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NCT03878095 · ClinicalTrials.gov registry record · Phase 2

Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors

A Phase 2 study of Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
24
Enrollment target
13
Study locations

NCT03878095 is a Phase 2 study of Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (98% lower). The trial reports 13 study locations across 10 states.

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The verdict

NCT03878095, a Phase 2 study of Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
24 participants
Enrollment target
13
Study locations

Study Summary

This phase II trial studies how well olaparib and ceralasertib (AZD6738) work in treating patients with IDH mutant cholangiocarcinoma or solid tumors. Cancer is caused by changes (mutations) to genes that control the way cells function. Laboratory studies have shown that olaparib and AZD6738 can shrink IDH mutant tumors or stop them from growing. Olaparib and ceralasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Biopsy Procedure
  • DRUG Ceralasertib

Study Locations (13)

Connecticut

  • Smilow Cancer Center/Yale-New Haven Hospital - New Haven
  • Yale University - New Haven
  • Smilow Cancer Hospital Care Center-Trumbull - Trumbull

Michigan

  • Wayne State University/Karmanos Cancer Institute - Detroit
  • Weisberg Cancer Treatment Center - Farmington Hills

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Florida

  • UF Health Cancer Institute - Gainesville - Gainesville

Illinois

  • Northwestern University - Chicago

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-01-30
Est. Completion 2026-07-10
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03878095

The ClinicalTrials.gov registry entry for NCT03878095 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (98% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03878095 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Connecticut, Michigan, Alabama.

Frequently Asked Questions

What is clinical trial NCT03878095 about?

NCT03878095 is a clinical study titled "Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors". This phase II trial studies how well olaparib and ceralasertib (AZD6738) work in treating patients with IDH mutant cholangiocarcinoma or solid tumors. Cancer is caused by changes (mutations) to genes that control the way cells function. Laboratory studies have shown that olaparib and AZD6738 can shr...

What is the current status of trial NCT03878095?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2020-01-30. Estimated completion is 2026-07-10.

What conditions does trial NCT03878095 study?

This clinical trial studies the following conditions: Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Refractory Cholangiocarcinoma.

What interventions are being tested in trial NCT03878095?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Biopsy Procedure (PROCEDURE), Ceralasertib (DRUG).

Who is sponsoring clinical trial NCT03878095?

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

Where is trial NCT03878095 being conducted?

This trial has 13 study locations across Alabama, Connecticut, Florida, Illinois, Maryland. 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

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