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ETCTN10222 A Phase II study of olaparib and AZD6738 in isocitrate dehydrogenase (IDH) mutant solid tumors
Protocol Number:
Phase II
Nilofer Azad
Johns Hopkins Kimmel Cancer Center in Baltimore
This phase II trial studies how well olaparib and ceralasertib 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.
Patients must have biopsy-confirmed evidence of an IDH1 or IDH2 mutation, confirmed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, associated with neomorphic activity of the encoded proteins.Subjects must be diagnosed with a cholangiocarcinoma or other solid malignant tumor that has progressed despite standard therapy, or for which no effective standard therapy exists. Patients with primary central nervous system (CNS) tumors, e.g. glioma, are not allowed.Patients must have tumors determined to be easily accessible for biopsy and must be willing to have serial biopsies.Patients must be willing to undergo extra blood sampling for correlative studies.Patients must have evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Patients receive olaparib PO BID on days 1-28 and ceralasertib PO QD on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Last Update
08/08/2020 05:02 AM