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NCT02996825 · ClinicalTrials.gov registry record · Phase 1
Mirvetuximab Soravtansine and Gemcitabine Hydrochloride in Treating Patients With FRalpha-Positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial, or Triple Negative Breast Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT02996825: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT02996825 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02996825, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer that has come back. Mirvetuximab soravtansine is a monoclonal antibody, called mirvetuximab, linked to a chemotherapy drug called DM4. Mirvetuximab attaches to FOLR1 positive cancer cells in a targeted way and delivers DM4 to kill them. Drugs used in the chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mirvetuximab soravtansine and gemcitabine may work better in treating patients with FRalpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer.
Primary Outcome
Tables will be created to summarize toxicities by dose level, cycles delivered, and total dose delivered, and side effects by dose and by cycle.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Gemcitabine
- DRUG Gemcitabine Hydrochloride
- OTHER Pharmacological Study
- BIOLOGICAL Mirvetuximab Soravtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-03-22 |
| Est. Completion | 2024-02-09 |
| Phase | Phase 1 |
What the finished NCT02996825 record still lists
NCT02996825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02996825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02996825 about?
NCT02996825 is a clinical study titled "Mirvetuximab Soravtansine and Gemcitabine Hydrochloride in Treating Patients With FRalpha-Positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial, or Triple Negative Breast Cancer". This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer that has come back. Mirvetuxim...
What is the current status of trial NCT02996825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2017-03-22. Estimated completion is 2024-02-09.
What interventions are being tested in trial NCT02996825?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Gemcitabine (DRUG), Gemcitabine Hydrochloride (DRUG), Pharmacological Study (OTHER), Mirvetuximab Soravtansine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02996825?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02996825's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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