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A Phase 3, open-label, randomized 2-arm study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma
Status: Recruiting
This study compares treatment with niraparib to temozolomide in adult participants who have newly-diagnosed, MGMT unmethylated glioblastoma.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• newly-diagnosed intracranial Glioblastoma (GBM)
• unmethylated MGMT promoter
• no prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy
• not pregnant, planning to get pregnant, or breastfeeding
• for participants of child bearing age, highly effective birth control is required
• normal blood pressure (BP) or adequately treated and controlled hypertension (defined as systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg)
• able to swallow oral medications whole
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• metastatic or predominant leptomeningeal disease
• Current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study
• gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels
• cirrhosis or current unstable liver or biliary disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:
Drug: Niraparib, Drug: Temozolomide
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), Brain Tumor, GBM, Glioblastoma
Study Contact: Elizabeth Neil - neile@umn.edu
Principal Investigator: Elizabeth Neil
Phase: PHASE3
IRB Number: STUDY00024466
See this study on ClinicalTrials.gov