Trial Summary
What is the purpose of this trial?This trial is testing olaparib and ceralasertib in patients with specific genetic mutations in their cancer. The drugs work by stopping cancer cells from repairing themselves and growing. The goal is to see if this combination can be more effective for these hard-to-treat cancers. Olaparib has been approved for use in various cancers, including ovarian and breast cancer.
Eligibility Criteria
This trial is for adults (18+) with IDH1 or IDH2 mutant cholangiocarcinoma or solid tumors that have progressed despite standard therapy, or no effective therapy exists. Participants must be willing to provide tissue samples and undergo extra blood sampling. They should not have severe chronic health issues, uncontrolled infections, or a history of certain heart conditions. Women must use contraception, and men agree to prevent partner pregnancy.Treatment Details
The phase II trial tests the effectiveness of olaparib and ceralasertib in treating patients with specific gene mutations in their tumors. These drugs may block enzymes needed for tumor cell growth. The study involves computed tomography, biopsies, bone marrow aspirations, and MRI scans to monitor treatment effects.
1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib, ceralasertib)Experimental Treatment8 Interventions
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 or unacceptable toxicity. 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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
University of Wisconsin Carbone Cancer Center - University HospitalMadison, WI
University of Wisconsin Carbone Cancer CenterMadison, WI
University of Wisconsin Hospital and ClinicsMadison, WI
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor