Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03878095
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsies
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Ceralasertib — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT scans
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI scans
  • Olaparib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jan 30, 2020
Status verified
Jan 2026
Primary completion
Mar 12, 2025
Completion
Jul 10, 2026

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (olaparib, ceralasertib)
    Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 30 days post treatment after removal from study ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Smilow Cancer Hospital Care Center-TrumbullTrumbullConnecticut06611-
UF Health Cancer Institute - GainesvilleGainesvilleFlorida32610-
Northwestern UniversityChicagoIllinois60611-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Weisberg Cancer Treatment CenterFarmington HillsMichigan48334-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
M D Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALSmilow Cancer Center/Yale-New Haven Hospital· New Haven, CTYale University· New Haven, CTSmilow Cancer Hospital Care Center-Trumbull· Trumbull, CTUF Health Cancer Institute - Gainesville· Gainesville, FLNorthwestern University· Chicago, IL

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