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NCT03587311 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Platinum-Resistant Ovarian Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT03587311: Active Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Platinum-Resistant Ovarian Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03587311 is a Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Platinum-Resistant Ovarian Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 96 participants, below the 296-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03587311, a Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Platinum-Resistant Ovarian Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the side effects of bevacizumab and anetumab ravtansine or paclitaxel in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that does not respond to treatment (refractory). Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Anetumab ravtansine is a drug that targets a protein in the body called mesothelin, which can be found in some ovarian, pancreatic and other tumors. Chemotherapy drugs, such as paclitaxel, 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. It is not yet known whether giving bevacizumab and anetumab ravtansine or paclitaxel may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome
PFS will be estimated using the Kaplan-Meier method and compared between groups with log rank test. Summary statistics will be provided, such as the median, 6-month and estimates, along with 95% confidence intervals. Plots will also be constructed which show the PFS estimate and 95% confidence intervals.
Conditions Studied
Interventions
- DRUG Paclitaxel
- BIOLOGICAL Bevacizumab
- BIOLOGICAL Anetumab Ravtansine
Study Locations (20)
Kansas
- HaysMed - Hays
- The University of Kansas Cancer Center - Olathe - Olathe
- Mercy Hospital Pittsburg - Pittsburg
- Salina Regional Health Center - Salina
- University of Kansas Health System Saint Francis Campus - Topeka
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
- Moffitt Cancer Center - Tampa
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
- Weisberg Cancer Treatment Center - Farmington Hills
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Colorado
- UCHealth University of Colorado Hospital - Aurora
Illinois
- Northwestern University - Chicago
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2018-10-12 |
| Est. Completion | 2026-10-21 |
| Phase | Phase 2 |
What the registry record for NCT03587311 still lists
NCT03587311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 296-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (68% lower).
The record links to 8 conditions, with Ovarian Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Paclitaxel is the first listed.
NCT03587311 names 20 study sites across 10 states, led by Kansas, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT03587311 about?
NCT03587311 is a clinical study titled "Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Patients With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This phase II trial studies the side effects of bevacizumab and anetumab ravtansine or paclitaxel in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that does not respond to treatment (refractory). Bevacizumab is a monoclonal antibody that may interfere with the ability ...
What is the current status of trial NCT03587311?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2018-10-12. Estimated completion is 2026-10-21.
What conditions does trial NCT03587311 study?
This clinical trial studies the following conditions: Ovarian Endometrioid Adenocarcinoma, Platinum-Resistant Ovarian Carcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Ovarian High Grade Serous Adenocarcinoma.
What interventions are being tested in trial NCT03587311?
The interventions under investigation include: Paclitaxel (DRUG), Bevacizumab (BIOLOGICAL), Anetumab Ravtansine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03587311?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03587311 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03587311's enrollment target sits among peer trials
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Each bar is a band; taller bars hold more other Ovarian Endometrioid Adenocarcinoma 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.
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