Clinical trial
PH3 Study of IMGN853 vs Investigator's Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer (FORWARD I)
This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of IMGN853 to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.
Primary Outcome Measures:
- Progression free survival in all patients randomized to the study and in patients with high folate receptor alpha expression [ Time Frame: Up to 2 years ]
Secondary Outcome Measures:
- Objective response rate (ORR) per RECIST1.1 [ Time Frame: Up to 2 years ]
- Overall survival (OS) as measured from the date of randomization until the date of death. [ Time Frame: Up to 2 years ]
- Quality of life [ Time Frame: Up to 2 years ]
| Category | Value |
|---|---|
| Date last updated at source | 2017-04-03 |
| Study type(s) | Interventional |
| Expected enrolment | 333 |
| Study start date | 2015-12-01 |
| Estimated primary completion date | 2018-11-01 |