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NCT01609556 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
A Phase 1 study, sponsored by ImmunoGen.
- Completed
- Registry status
- Phase 1
- Development phase
- 206
- Enrollment target
NCT01609556: Completed Phase 1 study, sponsored by ImmunoGen.
NCT01609556 is a Phase 1 study that has completed, run by ImmunoGen. The registered enrollment target is 206 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (243% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01609556, a Phase 1 study, has completed, sponsored by ImmunoGen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 206 participants
- Enrollment target
Study Summary
The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.
Primary Outcome
MTD was defined as the highest dose at which 1 or fewer among 6 participants or less than or equal to (\<=) 33 percent (%) experienced a dose-limiting toxicity (DLT) (calculated based on adjusted ideal body weight \[AIBW\]). AIBW was calculated as ideal body weight (IBW) + 0.4 \* (actual weight - IBW), where IBW for men was 0.9 \* height in centimeters (cm) - 88 and IBW for women was 0.9 \* height in cm - 92. DLT was defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory val
Interventions
- DRUG Mirvetuximab soravtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2012-06-28 |
| Est. Completion | 2018-03-19 |
| Phase | Phase 1 |
What the finished NCT01609556 record still lists
NCT01609556 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (243% higher).
The record links to 0 conditions, and to 1 intervention - of which Mirvetuximab soravtansine is the first listed.
NCT01609556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01609556 about?
NCT01609556 is a clinical study titled "First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors". The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.
What is the current status of trial NCT01609556?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 206 participants. The study started on 2012-06-28. Estimated completion is 2018-03-19.
What interventions are being tested in trial NCT01609556?
The interventions under investigation include: Mirvetuximab soravtansine (DRUG).
Who is sponsoring clinical trial NCT01609556?
This trial is sponsored by ImmunoGen, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01609556's enrollment target sits among peer trials
206 253rd of 2000 higher than 1,748 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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