At a glance
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A Phase II Study of Olaparib and AZD6738 in Isocitrate Dehydrogenase (IDH) Mutant Solid Tumors
In Brief
A Phase 2 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 6 other interventions for Malignant Solid Neoplasm and 2 related conditions. Active but no longer recruiting, targeting 24 participants across 13 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & 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, 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.
Interventions
Undergo tumor biopsies
Undergo collection of blood
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Given PO
Undergo CT scans
Undergo MRI scans
Given PO