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NCT02484404 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...

A Phase 1 study of Breast Neoplasms and Colorectal Neoplasms, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
268
Enrollment target
1
Study location

NCT02484404 is a Phase 1 study of Breast Neoplasms and Colorectal Neoplasms that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 268 participants, below the 566-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02484404, a Phase 1 study of Breast Neoplasms and Colorectal Neoplasms, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
268 participants
Enrollment target
1
Study location

Study Summary

Background: \- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2 part of this study, researchers want to study if the combination treatments are effective in ovarian cancer. Objectives: \- Phase 2 part of the study: To determine how effective this combination is in treating ovarian cancer. Eligibility: \- Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian cancer that has no standard treatment. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. They will have CT or MRI scans. For these, they will lie in a machine that takes pictures of their bodies. * Phase 2 part of the study requests the participants to have tumor samples removed. * Participants will get Durvalumab through an IV. A small plastic tube will be inserted into a vein. The drug will be given every 4 weeks until disease progression. * Participants will take olaparib or cediranib by mouth every day. * Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All other cycles, they will have 1 visit. At these visits, they will repeat the screening procedures. * Patients will keep a drug and diarrhea diary. * Patients on cediranib will monitor their blood pressure and keep a blood pressure diary. * Participants who can become pregnant, or have a partner who can become pregnant, must practice an effective form of birth control. * After 12 cycles, participants will have 1-3 months of follow-up.

Conditions Studied

Breast Neoplasms Colorectal Neoplasms

Interventions

  • DRUG Olaparib
  • DRUG Durvalumab
  • DRUG Cediranib

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 268 participants
Start Date 2015-06-29
Est. Completion 2026-07-01
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 NCT02484404

The ClinicalTrials.gov registry entry for NCT02484404 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 566-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (53% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Olaparib is the first listed.

NCT02484404 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02484404 about?

NCT02484404 is a clinical study titled "Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...". Background: \- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phas...

What is the current status of trial NCT02484404?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 268 participants. The study started on 2015-06-29. Estimated completion is 2026-07-01.

What conditions does trial NCT02484404 study?

This clinical trial studies the following conditions: Breast Neoplasms, Colorectal Neoplasms.

What interventions are being tested in trial NCT02484404?

The interventions under investigation include: Olaparib (DRUG), Durvalumab (DRUG), Cediranib (DRUG).

Who is sponsoring clinical trial NCT02484404?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02484404 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.