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Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors

NCT03878095 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-29

Study results available
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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.

Conditions

  • Malignant Solid Neoplasm
  • Refractory Cholangiocarcinoma
  • Refractory Malignant Solid Neoplasm

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor biopsies

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

DRUG

Ceralasertib

Given PO

PROCEDURE

Computed Tomography

Undergo CT scans

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI scans

DRUG

Olaparib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Patricia M LoRusso · Yale University Cancer Center LAO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2025-03-12
Completion
2026-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878095 on ClinicalTrials.gov