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NCT02446600 · ClinicalTrials.gov registry record · Phase 3
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 3 study of Recurrent Fallopian Tube Carcinoma and Ovarian Clear Cell Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 579
- Enrollment target
- 20
- Study locations
NCT02446600: Active Phase 3 study of Recurrent Fallopian Tube Carcinoma and Ovarian Clear Cell Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT02446600 is a Phase 3 study of Recurrent Fallopian Tube Carcinoma and Ovarian Clear Cell Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 579 participants, above the 213-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (172% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02446600, a Phase 3 study of Recurrent Fallopian Tube Carcinoma and Ovarian Clear Cell Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 579 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin 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. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Echocardiography Test
- DRUG Cediranib Maleate
Study Locations (20)
California
- PCR Oncology - Arroyo Grande
- Mercy San Juan Medical Center - Carmichael
- Marin Cancer Care Inc - Greenbrae
- UC San Diego Moores Cancer Center - La Jolla
- Cedars Sinai Medical Center - Los Angeles
- Palo Alto Medical Foundation-Camino Division - Mountain View
- Palo Alto Medical Foundation-Gynecologic Oncology - Mountain View
- Kaiser Permanente-Oakland - Oakland
- Palo Alto Medical Foundation Health Care - Palo Alto
- Sutter Roseville Medical Center - Roseville
- Mercy Cancer Center - Sacramento - Sacramento
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Alaska
- Alaska Women's Cancer Care - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- Arizona Oncology Associates-West Orange Grove - Tucson
- Arizona Oncology Associates-Wilmot - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2016-03-28 |
| Est. Completion | 2026-11-25 |
| Phase | Phase 3 |
What the registry record for NCT02446600 still lists
NCT02446600 is an interventional study that assigns participants to a tested intervention. The registered 579 participants enrollment target is mid-sized for trials with a published cap, above the 213-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (172% higher).
The record links to 10 conditions, with Recurrent Fallopian Tube Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT02446600 names 20 study sites across 5 states, led by California, Alabama, Alaska.
Frequently Asked Questions
What is clinical trial NCT02446600 about?
NCT02446600 is a clinical study titled "Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate m...
What is the current status of trial NCT02446600?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 579 participants. The study started on 2016-03-28. Estimated completion is 2026-11-25.
What conditions does trial NCT02446600 study?
This clinical trial studies the following conditions: Recurrent Fallopian Tube Carcinoma, Ovarian Clear Cell Adenocarcinoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Ovarian Seromucinous Carcinoma.
What interventions are being tested in trial NCT02446600?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), Cediranib Maleate (DRUG).
Who is sponsoring clinical trial NCT02446600?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02446600 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02446600's enrollment target sits among peer trials
579 3rd of 35 higher than 33 of 35 other Recurrent Fallopian Tube Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Fallopian Tube Carcinoma 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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