Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors (NCT03878095) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors
United States24 participantsStarted 2020-01-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must be able to understand the nature of this trial and provide written informed consent, prior to any study specific procedures. Patients with impaired decision making capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) may be considered eligible for this study at the treating physician's discretion, provided that the physician is reasonably sure that the possible risks and benefits of the study are clear and that the patient will take the drug as prescribed
* Subjects must be diagnosed with a solid malignant tumor (other than cholangiocarcinoma or primary central nervous system \[CNS\] tumor) that has progressed despite standard therapy, or for which no effective standard therapy exists. Patients with cholangiocarcinoma are no longer allowed as this cohort has closed to accrual. Patients with primary CNS tumors, e.g. glioma, are not allowed
* 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
* Patients must have tumors determined to be easily accessible for biopsy and must be willing to have serial biopsies. Tumor biopsies will be performed on the most accessible biopsiable site of disease. All possible precautions to avoid complications will be taken, including discussions in multidisciplinary meetings, if needed. If a patient opts out of a pre-tr…
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Up to 30 days post treatment after removal from study