Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 1

Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer

NCT01116648 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 155 participants
Start Date 2010-04-14
Est. Completion 2026-11-25
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01116648

The ClinicalTrials.gov registry entry for NCT01116648 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01116648 reports 14 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, Maryland, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01116648?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial