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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 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.

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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.

Conditions Studied

Triple-Negative Breast Carcinoma Ovarian Endometrioid Adenocarcinoma Fallopian Tube Carcinoma Ovarian High Grade Serous Adenocarcinoma Ovarian Serous Adenocarcinoma Primary Peritoneal Serous Adenocarcinoma Ovarian Serous Surface Papillary Adenocarcinoma

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)

3,257 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, categorized as Phase 1. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 20 other Triple-Negative Breast Carcinoma trials with a reported enrollment target (19% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 6 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.