Trials / Completed
CompletedNCT02631876
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer
FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 366 (actual)
- Sponsor
- ImmunoGen, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine 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.
Detailed description
Participants will be randomized to either mirvetuximab soravtansine or investigator's choice chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirvetuximab soravtansine | Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm. |
| DRUG | Paclitaxel | Paclitaxel will be administered per dose and schedule specified in the arm. |
| DRUG | Pegylated liposomal doxorubicin | Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm. |
| DRUG | Topotecan | Topotecan will be administered per dose and schedule specified in the arm. |
Timeline
- Start date
- 2016-03-02
- Primary completion
- 2019-01-01
- Completion
- 2020-01-01
- First posted
- 2015-12-16
- Last updated
- 2020-10-14
- Results posted
- 2020-06-09
Locations
131 sites across 13 countries: United States, Belgium, Bosnia and Herzegovina, Canada, Czechia, France, Ireland, Italy, Russia, Serbia, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02631876. Inclusion in this directory is not an endorsement.