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NCT01116648 · ClinicalTrials.gov registry record · Phase 1
Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer
A Phase 1 study of Triple-Negative Breast Carcinoma and Ovarian Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 155
- Enrollment target
- 14
- Study locations
NCT01116648: Active Phase 1 study of Triple-Negative Breast Carcinoma and Ovarian Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT01116648 is a Phase 1 study of Triple-Negative Breast Carcinoma and Ovarian Endometrioid Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 155 participants, below the 192-participant average among 20 other Triple-Negative Breast Carcinoma trials with a reported enrollment target (19% lower). The trial reports 14 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116648, a Phase 1 study of Triple-Negative Breast Carcinoma and Ovarian Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 155 participants
- Enrollment target
- 14
- Study locations
Study Summary
This partially randomized phase I/II trial studies the side effects and the best dose of cediranib maleate and olaparib and to see how well they work compared to olaparib alone in treating patients with ovarian, fallopian tube, peritoneal, or triple-negative breast cancer that has returned after a period of improvement (recurrent). Cediranib maleate may help keep cancer cells from growing by affecting their blood supply. Olaparib may stop cancer cells from growing abnormally. The combination of cediranib maleate and olaparib may be safe, tolerable and/or effective in treating patients with recurrent ovarian, fallopian tube, or peritoneal cancer or recurrent triple-negative breast cancer.
Primary Outcome
Was determined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
- DRUG Cediranib Maleate
Study Locations (14)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
- Massachusetts General Hospital - Charlestown
- Newton-Wellesley Hospital - Newton
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
- National Institutes of Health Clinical Center - Bethesda
- National Cancer Institute - Rockville
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- NorthShore University HealthSystem-Evanston Hospital - Evanston
Indiana
- Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard - Fort Wayne
- Fort Wayne Medical Oncology and Hematology Inc-Parkview - Fort Wayne
California
- Cedars Sinai Medical Center - Los Angeles
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2010-04-14 |
| Est. Completion | 2026-11-25 |
| Phase | Phase 1 |
What the registry record for NCT01116648 still lists
NCT01116648 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 20 other Triple-Negative Breast Carcinoma trials with a reported enrollment target (19% lower).
The record links to 7 conditions, with Triple-Negative Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT01116648 lists 14 locations in 6 states (Massachusetts, Maryland, Illinois).
Frequently Asked Questions
What is clinical trial NCT01116648 about?
NCT01116648 is a clinical study titled "Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer". This partially randomized phase I/II trial studies the side effects and the best dose of cediranib maleate and olaparib and to see how well they work compared to olaparib alone in treating patients with ovarian, fallopian tube, peritoneal, or triple-negative breast cancer that has returned after a p...
What is the current status of trial NCT01116648?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2010-04-14. Estimated completion is 2026-11-25.
What conditions does trial NCT01116648 study?
This clinical trial studies the following conditions: Triple-Negative Breast Carcinoma, Ovarian Endometrioid Adenocarcinoma, Fallopian Tube Carcinoma, Ovarian High Grade Serous Adenocarcinoma, Ovarian Serous Adenocarcinoma.
What interventions are being tested in trial NCT01116648?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Cediranib Maleate (DRUG).
Who is sponsoring clinical trial NCT01116648?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01116648 being conducted?
This trial has 14 study locations across California, Illinois, Indiana, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple-Negative Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01116648's enrollment target sits among peer trials
155 4th of 20 higher than 17 of 20 other Triple-Negative Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple-Negative Breast 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.
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