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A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)
Status: Recruiting
The purpose of this research is to collect information about the safety and tolerability of the study drug ACE-232, along with how well it works to control metastatic castration-resistant prostate cancer (mCRPC).
Sex: Male
Age Group: 18 years and over
Inclusion Criteria:
• diagnosis of Metastatic Castration-resistant Prostate Cancer (MCRPC) with - ongoing androgen deprivation therapy (ADT) or had bilateral orchiectomy
• difficult to treat or intolerant to standard treatment
• 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
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• spinal cord compression or known brain metastases
• severe cardiovascular disorders
• known gastrointestinal (GI) disorder or GI procedure
• poorly controlled diabetes
• active or uncontrolled autoimmune disease
• see link to clinicaltrials.gov for complete exclusion criteria
Interventions:
Drug: ACE-232 tablets
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), MCRPC, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer
Study Contact: Emmanuel Antonarakis - anton401@umn.edu
Principal Investigator: Emmanuel Antonarakis
Phase: PHASE1
IRB Number: STUDY00024643
See this study on ClinicalTrials.gov