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NCT06365853 · ClinicalTrials.gov registry record · Phase 2
A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
A Phase 2 study of Recurrent Ovarian Cancer and Folate Receptor-Alpha Positive, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06365853: Recruiting Phase 2 study of Recurrent Ovarian Cancer and Folate Receptor-Alpha Positive, sponsored by AbbVie.
NCT06365853 is a Phase 2 study of Recurrent Ovarian Cancer and Folate Receptor-Alpha Positive that is actively recruiting participants, run by AbbVie. The registered enrollment target is 100 participants, below the 174-participant average among 6 other Recurrent Ovarian Cancer trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06365853, a Phase 2 study of Recurrent Ovarian Cancer and Folate Receptor-Alpha Positive, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression.
Primary Outcome
This endpoint will be assessed in the participants receiving MIRV who are asymptomatic .
Conditions Studied
Interventions
- DRUG Mirvetuximab Soravtansine
- DRUG Lubricating Eye Drops
- DRUG Prednisolone acetate ophthalmic suspension 1% eye drops
- DRUG Brimonidine tartrate ophthalmic solution eye drops
Study Locations (20)
Oost-Vlaanderen
- OLV Ziekenhuis Aalst /ID# 269311 - Aalst
- AZ Sint-Lucas /ID# 269307 - Ghent
- UZ Gent /ID# 269309 - Ghent
New York
- New York Oncology Hematology - Albany Cancer Center /ID# 269345 - Albany
- Women'S Cancer Care Associates /ID# 269980 - Albany
Texas
- UT Southwestern Medical Center /ID# 269341 - Dallas
- Memorial Hermann Southeast Hospital /ID# 269347 - Houston
New South Wales
- Blacktown Hospital /ID# 269305 - Blacktown
- Newcastle Private Hosptial /ID# 269306 - Lambton Heights
California
- University of California Los Angeles /ID# 269339 - Los Angeles
Kentucky
- Norton Cancer Institute - St. Matthews /ID# 269070 - Louisville
Maryland
- Holy Cross Hospital - Silver Spring /ID# 269344 - Silver Spring
Missouri
- Mercy David C. Pratt Cancer Center /ID# 269350 - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-07-29 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What NCT06365853 shows while recruiting
NCT06365853 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 174-participant average among 6 other Recurrent Ovarian Cancer trials with a reported enrollment target (43% lower).
The record links to 2 conditions, with Recurrent Ovarian Cancer appearing as the primary indexed condition, and to 4 interventions - of which Mirvetuximab Soravtansine is the first listed.
NCT06365853 names 20 study sites across 15 states, led by Oost-Vlaanderen, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT06365853 about?
NCT06365853 is a clinical study titled "A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression". The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic ev...
What is the current status of trial NCT06365853?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-07-29. Estimated completion is 2027-06.
What conditions does trial NCT06365853 study?
This clinical trial studies the following conditions: Recurrent Ovarian Cancer, Folate Receptor-Alpha Positive.
What interventions are being tested in trial NCT06365853?
The interventions under investigation include: Mirvetuximab Soravtansine (DRUG), Lubricating Eye Drops (DRUG), Prednisolone acetate ophthalmic suspension 1% eye drops (DRUG), Brimonidine tartrate ophthalmic solution eye drops (DRUG).
Who is sponsoring clinical trial NCT06365853?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06365853 being conducted?
This trial has 20 study locations across California, Kentucky, Maryland, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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