7 results
Primary Objectives:*To explore whether early abiraterone exposure (AUC) is corre*lated to treatment response after 3 months and 6 months of therapy (primarily based on radiographic response (RECIST re*sponse: SD, PR, CR) and secondary on…
To determine the efficacy (as assessed by rPFS) and safety of olaparib versus investigator choice of enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal…
Primary objective:To determine the equivalent dose of abiraterone when taken with a continental breakfast compared to 1000 mg in fasted stateSecondary objective:To evaluate the preference of the patients: intake of abiraterone with or without food
To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…
Phase 2:• To assess the safety, tolerability, systemic exposure, and efficacy of AMT-101 in subjects with chronic antibiotic-resistant pouchitis• To select an AMT-101 dose for Phase 3Phase 3:Co-primary Objectives:• To determine the effect of AMT-101…
The purpose of this study is to understand if a new treatment for prostate cancer (niraparib) added to a standard treatment (abiraterone acetate plus prednisone) will work better than the standard treatment alone.Cohort 3: the purpose is to evaluate…
Primary: * To assess Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy.Secondary: * To formally compare CBR in both…