Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
Conditions
Brief summary
The dual primary efficacy endpoints include the following: • PFS: Time from randomization until first documented progressive disease (PD) by RECIST v1.1 per BICR, or death due to any cause, whichever occurs first, • ▪ OS: Time from randomization to death by any cause.
Detailed description
• PFS (Investigators): Time from randomization until PD or death whichever occurred first as assessed by Investigator using RECIST v1.1., • ORR: Proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1. • BoR: Recorded from the date of randomization until PD/recurrence (or death). • DoR: Time from the first objective response (CR or PR) to first objectively documented PD or death (whichever occurs first)., • CBR at 24 weeks: proportion of patients who attain CR, PR, or stable disease (SD) for 24 weeks as per RECIST v1.1. • CA-125 response will be assessed per GCIG criteria • Combined response according to RECIST v1.1 + GCIG criteria. Responses will be reported separately and combined for RECIST v1.1 and CA-125/GCIG criteria.
Interventions
Sponsors
Corcept Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dual primary efficacy endpoints include the following: • PFS: Time from randomization until first documented progressive disease (PD) by RECIST v1.1 per BICR, or death due to any cause, whichever occurs first, • ▪ OS: Time from randomization to death by any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| • PFS (Investigators): Time from randomization until PD or death whichever occurred first as assessed by Investigator using RECIST v1.1., • ORR: Proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1. • BoR: Recorded from the date of randomization until PD/recurrence (or death). • DoR: Time from the first objective response (CR or PR) to first objectively documented PD or death (whichever occurs first)., • CBR at 24 weeks: proportion of patients who attain CR, PR, or stable disease (SD) for 24 weeks as per RECIST v1.1. • CA-125 response will be assessed per GCIG criteria • Combined response according to RECIST v1.1 + GCIG criteria. Responses will be reported separately and combined for RECIST v1.1 and CA-125/GCIG criteria. | — |
Countries
Belgium, France, Hungary, Italy, Poland, Spain
Outcome results
None listed