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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

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A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration- Resistant Prostate Cancer Previously Treated With Chemotherapy

This is a research study designed to test how well a new medication (xaluritamig) works compared to other treatments for people with metastatic castration-resistant prostate cancer. These patients have already been treated with a certain chemotherapy. Participants will be randomly assigned to one of two groups: xaluritamig or either cabazitaxel (existing cancer treatment) or another treatment chosen by the doctor. The goal of the study is to find out which treatment is more effective and safer for patients.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023844
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of adenocarcinoma of the prostate
• evidence of progressive disease
• completed requirements for previous treatment
• may not be able to do strenuous activity but able to walk and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of central nervous system (CNS) metastasis
• significant side effects from previous treatment that haven't resolved
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Metastatic Castration-resistant Prostate Cancer, Prostate
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A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine in platinum-resistant ovarian cancer

This study will enroll patients with ovarian cancer who have experienced their cancer worsening after at least two previous treatments. This study will give these patients OPB-101, a genetically engineered CAR-T cell therapy product - a product that will be created from the patient's own T-cells - that the researchers hope has been designed to more accurately recognize and destroy the cancer cells. The goal of this study is to make sure OPB-101 is safe to give, if it is effective against this type of cancer, and to find the best dose of OPB-101 to give patients.

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025091
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer
• recurrent platinum-resistant disease, cancer has recurred within 6 months of the last dose of platinum-based chemotherapy
• received at least 2 but no more than 3 prior lines of systemic chemotherapy including a platinum based chemotherapy
• may not be able to do strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• women childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after the last dose of therapy
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• uncontrolled bacterial, fungal, or viral infections
• active invasive cancer other than the cancer under study
• significant lung disease
• active central nervous system (CNS) involvement
• dependent on intravenous hydration or total parenteral nutrition
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC)
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MT2023-35: A Pilot Study to Identify Risk Factors for Long-Term Functional and Pulmonary Outcomes Following Allogeneic Hematopoietic Cell Transplantation for Oncologic Diagnoses.

The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what are the best methods for diagnosing lung problems and follow-up care. The lung problems that may develop after transplant varies from patient to patient, and we don’t exactly know what risk factors influence who develops them or how patients respond to pulmonary (breathing system) therapies. Also, we wish to improve how we monitor lung function and quality of life after transplant, especially in children and young adults.

Principal Investigator: Alex Hoover
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021591
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Sex: Male or Female
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 0 to 25 years at the time of Hematopoietic Cell Transplantation (HCT)
• received stem cell transplant for cancer
• receive ongoing care at the University of Minnesota Childhood Cancer/BMT Survivor Program
Exclusion Criteria:

• people who don't speak or read English
Conditions: Cancer
Keywords: HCT, Hematopoietic Cell Transplantation
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Post-contracture release radiation for Dupuytren's disease

The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes

Principal Investigator: Leslie Chang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00002191
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnoses of Dupuytren's disease
• English-speaking
Exclusion Criteria:

• people who have Dupuytren's disease and are not currently seeking treatment
Keywords: Dupuytren Contracture, Dupuytren's Disease
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A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors (FOG-001-101)

This study is for people who have been diagnosed with cancer that is advanced (means disease has spread from the original site or has come back) or is metastatic (means the disease has spread to other parts of the body). FOG-001 is currently being developed to treat people with cancer. We want see how safe and tolerable FOG-001 is when given alone and together with other anticancer drugs at different dose levels in participants. We also want to see how FOG-001 affects the body and the cancer

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025544
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• locally advanced or metastatic solid tumor
• may not be able to do physically strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for specific requirements by type of tumor
Exclusion Criteria:

• history of bone metastasis except patients with mCRPC
• Osteoporosis
• uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
• women who are pregnant, breastfeeding, or planning to be come pregnant
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: cancer, metastatic cancer, Clinics and Surgery Center (CSC), solid tumor
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A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naïve Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00007800
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Conditions: Cancer, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
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A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS)

This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023797
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• new diagnosis of non-small cell lung cancer (NSCLC) OR metastatic (in other areas of the body) or is too advanced for treatment that will cure the cancer
• tumor has an epidermal growth factor receptor gene (EGFR) mutation
• able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work, but can't do strenuous physical activity
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• not have fully recovered from surgery, or has surgery planned during the time the participant is expected to be in the study
• uncontrolled tumor-related pain
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), non-small cell lung cancer, NSCLC
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HM2025-23: Phase 3 Randomized, Double-Blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 mutated or KMT2A Rearranged Acute Myeloid Leukemia

AML is a type of blood cancer where infection fighting cells called white blood cells (WBCs) don’t grow up or “mature” like they are supposed to. Instead, they stay stuck as infant or immature “blast” cells. This study will investigate the potential risks and benefits of adding a targeted therapy called ziftomenib to intensive therapy (7+3) OR non-intensive (Venetoclax + Azacitidine) for patients whose cancers are found to have KMT2A rearrangements or mutations in the NPM1 gene. We will also see if the use of ziftomenib as maintenance therapy following consolidation is beneficial.

Principal Investigator: Jeremy Allred
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026093
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Acute Myeloid Leukemia (AML)
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• must agree to use a highly effective method of birth control
• see link to clincialtrials.gov for complete Inclusion criteria
Exclusion Criteria:

• received prior therapy for AML
• involvement of central nervous system
• history of another type of cancer
• women who are pregnant or breastfeeding
• other significant medical illness,
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)

The purpose of this research is to measure the safety and effectiveness of ivonescimab compared to pembrolizumab. Ivonescimab is an antibody designed to block proteins that help cancer cells grow and spread, and by blocking these proteins may potentially slow cancer progression. Participants will have a 50% chance of being assigned to either the ivonescimab treatment group or the pembrolizumab treatment group.

Principal Investigator: Faysal Haroun
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025046
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• may be restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• diagnosis of metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC)
• have not received any treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• small cell lung cancer
• known genetic alterations that have treatment options
• have received treatment for this cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Non-Small Cell Lung Cancer, NSCLC
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A Phase Ib open label randomised clinical trial to evaluate safety and efficacy of BI 770371 in combination with pembrolizumab with or without cetuximab compared with pembrolizumab monotherapy for the first-line treatment of patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

The goal of this study is to find out whether combining different study drugs makes tumors shrink in people with advanced head and neck cancer. This type of cancer is in the mouth, nose, throat, and sinuses. The study drugs are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 1 out of 3 groups, by chance (like drawing names from a hat), and which of the study treatments participants will receive.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024665
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) of the primary tumor location of oral cavity, oropharynx, hypopharynx, and larynx
• have not received prior systemic treatment for metastatic or recurrent HNSCC
• do not have contraindications to pembrolizumab
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Nasopharyngeal cancer (NPC)
• progressive HNSCC within 6 months of completion of systemic therapy
• prior allogeneic stem cell or solid organ transplantation
• see link to clinicaltrials.gov for complete Exclusion critieria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Head and Neck Squamous Cell Carcinoma, HNSCC
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MT2020-08 A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or azer-cel), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.

Principal Investigator: Supriya Gupta
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00009953
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
Exclusion Criteria:

• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
Conditions: Cancer
Keywords: Non-Hodgkin Lymphoma, Clinics and Surgery Center (CSC)
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MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.

This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019229
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed diagnosis of an advanced, and/or metastatic or relapsed/refractory solid tumor that can not be surgically removed
• must have exhausted available treatment options or refused established treatment options
• restricted from physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for additional Inclusion criteria
Exclusion Criteria:

• major surgery or radiation therapy in the past 4 weeks
• active hepatitis B or C infection
• severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation (study staff will review)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Solid Tumors, Clinics and Surgery Center (CSC)
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TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes (TADPOL)

This study is looking at the safety and effects of Difluoromethylornithine (DFMO) and its effect on insulin production in people who have been newly diagnosed with type 1 diabetes. DFMO is a drug that is FDA-approved for other uses, but is being looked at in this study for preserving beta cell function. Participants will be randomized (like flipping a coin) to take either the placebo medicine or Difluoromethylornithine (DFMO) for 6 months followed by 6 months of no medication. Of all people participating in the study, 2 out of 3 people will receive DFMO and 1 out of 3 people will receive placebo treatment. Participation in this study will be approximately 12 months.

Principal Investigator: Brandon Nathan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024995
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 4 to 40 years old
• diagnosis of Type 1 Diabetes (T1D) and started insulin no more than 100 days before starting this clinical trial
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• any severe, active disease that interferes with food intake or requires the use of chronic medication, with the exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids
• unable to swallow pills
• current use of anti-psychotic medication
• allergy to milk or soy
• women & men of child bearing age must agree to use approved birth control
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: T1D, Type 1 Diabetes

A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53WILD-TYPE, ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA (XPORT-EC-042)

The purpose of this research study is to further evaluate the safety and effectiveness of selinexor for maintenance in patients with TP53 wild-type endometrial cancer.

Principal Investigator: Britt Erickson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025314
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed Endometrial cancer including: endometrioid, serous, undifferentiated, and carcinosarcoma
• Stage IV disease at diagnosis or first relapse
• may be unable to do physically strenuous activity but walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• gastrointestinal disease that could interfere with the absorption of selinexor (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea)
• serious psychiatric or medical condition that could interfere with participation
• another cancer in the past 3 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Endometrial Cancer
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MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.

Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021781
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 0 to 75 years old
• diagnosis of Idiopathic Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), Acquired Amegakaryocytic Thrombocytopenia, Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, SA
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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors (BEHOLD-1)

This study is being done to test if GSK5733584, the study drug, can improve cancer, is safe, well-tolerated, works and helps to treat cancer, how the body reacts to and how the body uses the study drug at different doses.

Principal Investigator: Deanna Teoh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025827
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube or endometrial cancer that is metastatic or not able to have surgical treatment
• received or are intolerant to 1 but no more than 3 lines of prior systemic therapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• pleural/abdominal effusion/ascites requiring clinical intervention or presence of pericardial effusion
• brain metastasis unless asymptomatic
• heart arrhythmias or ECG abnormalities
• Left ventricular ejection fraction (LVEF) < 50%
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), cancer, neoplasm, solid tumors
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DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer (DE-01)

The purpose of this research is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy (Carboplatin and Paclitaxel).

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026413
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of epithelial endometrial cancer
• HER2 positive
• advanced disease (Stage III/IV) or first recurrent endometrial cancer
• first time systemic anticancer therapy or may have received one prior line of chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy
• may not be able to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• history of organ transplant
• other ongoing or active illness such as infection, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease requiring systemic treatment, heart or lung diseases
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Endometrial Cancer
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DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a breast cancer prevention pilot study

The trial offers women with ductal cell carcinoma in situ (DCIS) 6 months of neoadjuvant exposure to endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.

Principal Investigator: Jane Hui
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022523
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of HR+ DCIS (at least 50% ER or PR (from biopsy at diagnosis) with or without microinvasion
• may have received endocrine therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• breast cancer is invasive
• unable to swallow tablets or capsules
• gastrointestinal conditions that would interfere with absorption of medication -- see link to clinical trials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), breast cancer, DCIS
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A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors

This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024172
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer
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MT2022-49: Early identification of cognitive side-effects of immunotherapy

This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019811
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
Exclusion Criteria:

• presence of speech or hearing problem
• diagnosis of cognitive impairment
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), CAR-T, Chimeric Antigen Receptor T-Cell Therapy
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I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)

The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.

Principal Investigator: Douglas Yee, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011111
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
Exclusion Criteria:

• other medical or mental health diagnosis that would limit compliance with study requirements
Conditions: Cancer
Keywords: Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2, Clinics and Surgery Center (CSC)

A Phase 3, Open label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen in Children from 6 Years to less than 18 Years of Age with Active ANCA-associated Vasculitis (AAV)

Blood vessel inflammation can damage parts of the body. The medicines we use to treat AAV try to turn off the blood vessel inflammation to prevent damage to the body. The purpose of this study is to see how safe and how well a medicine called avacopan works when combined with a child’s regular medicine used to treat their AAV. This medicine is not approved in children, so will be called a “study drug.”

Principal Investigator: Bryce Binstadt
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023481
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 6 to 17 years old
• diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
• newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
• weigh at least 15 kg (33 lbs)
Exclusion Criteria:

• any other known multisystem autoimmune disease
• any medical condition requiring or expected to require continued use of immunosuppressive treatments, including corticosteroids
Conditions: Rare Diseases
Keywords: AAV, Active ANCA-associated Vasculitis, Vasculitis
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MT2022-52: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.

Principal Investigator: Mark Juckett
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00017906
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Bone Marrow Transplant, Leukemia, Stem Cell Transplant
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Phase I Study of Peptide Alarm Therapy (PAT) Administered by Intratumoral Injection with a PD-1/PD-L1 Inhibitor in Patients with Solid Tumor Cancers Who Have Failed Two Prior Therapies

This study is testing an “investigational” drug referred to as peptide alarm therapy (PAT) that was specially made for this study. PAT is using the peptide to stimulate the immune system for people who have failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi). The goal of the 1st part of the study is to identify an acceptable, safe dose of PAT and up to 3 dose levels of PAT will be tested. If dose level 3 is reached without toxicity, it becomes the dose used for the next part of the study. In the 2nd part of the study, additional patients are treated at the PAT dose identified as safe in the 1st part to gain additional safety information and provide an initial estimate of anti-cancer effect.

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015219
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• positive for Cytomegalovirus (CMV) and Epstein–Barr virus (EBV
• failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi).
• strenuous activity may be restricted; can do light work; able to walk
• people of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• active metastases to the central nervous system
• active autoimmune disease that has required systemic treatment in the past 2 years
• history of bone marrow and/or solid organ transplant
• other active medical conditions
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), metastasis, solid tumor
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Closed Loop and Education for hypoglycemia Awareness Restoration (CLEAR) (CLEAR)

The purpose of this study is to learn how to improve hypoglycemia unawareness - a condition where people with Type 1 Diabetes may not be able to tell how low their blood sugar levels are. This study will use different types of education and devices to see if they can help people become more aware when the blood sugar is low.

Principal Investigator: Elizabeth Seaquist
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022428
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• diagnosis of type 1 diabetes
• sometimes struggle to feel symptoms of low blood sugar
• have had diabetes for at least 10 years
• A1c no more than 10.5%
• able to read and speak English (because non-English versions of the tests and the educational materials are not available)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• medical conditions that limit participation in study activities, as determined by the physician (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)
• active alcohol or drug abuse
• seizure disorder unrelated to hypoglycemia, unless seizure-free for at 12 months and on stable therapy
• medical condition that requires intermittent or continuous use of glucocorticoids
• women who are pregnant, planning to become pregnant or are breastfeeding
• hospitalized for mental illness in last year
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: hypoglycemia unawareness, severe hypoglycemia, Diabetes, Hypoglycemia, T1D, Type 1 Diabetes

An Open-Label Multiple-Dose, 52-Week Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents (ages: 12 to <18 years) with Conditions Associated with Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism (Congenital or Acquired)

This is a study to see if a new drug, named XYOSTED Injection (study drug) will help in the treatment of male adolescents ages 12 to less than 18 years old who have low or no testosterone due to a medical condition called Hypogonadism. Male Hypogonadism is a condition in which the body doesn’t produce enough of the hormone called testosterone that plays a key role in masculine growth and development during puberty. Participation in the study will last 52 weeks.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025680
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Sex: Male
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:
-12 to < 18 years of age
• diagnosed with a deficiency or absence of testosterone due to hypogonadism
• if receiving testosterone treatment, must be on a stable dose for at least 12 weeks before starting the study
• body mass index (BMI)-for-age greater than the 5th percentile and weigh at least 40 kg (88 pounds)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• suspected or known constitutional growth delay in growth and puberty (CDGP)
• possible nutritional or gastrointestinal disorder that may impact growth
• allergy to foods or products containing sesame seeds or sesame oil
• history of suicidal behavior suicide attempts
• have a history of drug or alcohol abuse
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine, Rare Diseases
Keywords: hypogonadism, testosterone
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RANDOMIZED PHASE III TRIAL OF NEOADJUVANT IMMUNOTHERAPY WITH RESPONSE-ADAPTED TREATMENT VERSUS STANDARD-OFCARE TREATMENT FOR RESECTABLE STAGE III/IV CUTANEOUS SQUAMOUS CELL CARCINOMA

We are studying the use of immunotherapy before and after (in some cases) surgery to see if it will extend the length of time until the cancer returns compared to the usual approach. The usual approach for patients who are not in a study is treatment with surgery which may be followed by radiation. Participants will either get the study drug cemiplimab (REGN2810) before surgery for the cancer or will have up-front surgery. For those who receive cemiplimab (REGN2810), it will be given before surgery every 3 weeks for up to 12 weeks. In either case, participants may also receive radiation after surgery depending on the tumor tissue results from surgery.

Principal Investigator: Curtis Hanba
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025188
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
• previously untreated or recurrent CSCC
• walking and able to do self-care, but unable to work; up and about at least 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• history of solid organ or bone marrow transplant
• no active, known, or suspected autoimmune disease for the past 5 years
• current significant medical issues
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Eyelid Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma, Clinics and Surgery Center (CSC)
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A double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)

Nerandomilast is being developed to treat lung fibrosis. This study is to test a drug called nerandomilast in people with SARD-ILD who also take an immunosuppressant medicine. Participants are put into 2 groups randomly, which means by chance and will receive either nerandomilast or placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any study drug. Participants will be in the study for about 7.5 to 13 months depending on when they join the study.

Principal Investigator: Hyun Kim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024424
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD)
• lung function has not improved with immunosuppressant (IS) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active vasculitis
• suicidal behavior in the past 2 years
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Rare Diseases, Rare Diseases, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Autoimmune Rheumatic Diseases, Interstitial Lung Diseases
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A PHASE III TRIAL OF ONE VS. TWO YEARS OF MAINTENANCE OLAPARIB, WITH OR WITHOUT BEVACIZUMAB, IN PATIENTS WITH BRCA1/2 MUTATED OR HOMOLOGOUS RECOMBINATION DEFICIENT (HRD+) OVARIAN CANCER FOLLOWING RESPONSE TO FIRST LINE PLATINUM-BASED CHEMOTHERAPY

The usual approach for patients who are not in a study is treatment of ovarian cancer with surgery, radiation, or U.S. Food and Drug Administration (FDA)-approved drugs. Sometimes, combinations of these treatments are used. We are doing this study because we want to find out if the use of Olaparib for one year is as good or worse than the usual approach for ovarian tumor.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024824
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• newly diagnosed, confirmed stage III or IV ovarian cancer of the following types: high grade serous or endometrioid, or other epithelial ovarian cancer with BRCA1/2 alteration
• ovarian cancer includes ovarian, fallopian, or primary peritoneal cancer
• must have had cytoreductive surgery
• must have completed first line platinum-based therapy before starting the study (no more than 12 weeks prior)
• not pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Fallopian Tube Cancer, Ovarian Cancer, Clinics and Surgery Center (CSC)
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A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants (AGLOW)

To evaluate the efficacy, safety, and pharmacokinetics of VX-407 in participants with Autosomal Dominant Polycystic Kidney Disease with PKD1 gene variants

Principal Investigator: Katti Woerner
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026103
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Participants between the ages of 18 and 65 years, inclusive.
• Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
• participants with a pre-existing diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Kidney disease other than ADPKD that in the opinion of the investigator would independently impact the natural history of ADPKD
• Solid organ or bone marrow transplantation, or nephrectomy
• Any condition possibly affecting drug absorption (e.g., gastrectomy, gastrointestinal tract surgery except appendectomy and cholecystectomy
• Clinically significant liver dysfunction
Conditions: Kidney, Prostate & Urinary, Rare Diseases
Keywords: autosomal dominant polycystic kidney disease (ADPKD), kidney disease, Clinics and Surgery Center (CSC)