Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Malignant Solid Neoplasm
- Refractory Cholangiocarcinoma
- Refractory Malignant Solid Neoplasm
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the overall response rates of olaparib and ceralasertib (AZD6738) in subjects with recurrent/progressive IDH1/2-mutant solid malignant tumors, who will be recruited to 2 cohorts: a. Cholangiocarcinoma b. Other solid malignant tumors. SECONDARY OBJECTIVES: I. To ass...
PRIMARY OBJECTIVE: I. To determine the overall response rates of olaparib and ceralasertib (AZD6738) in subjects with recurrent/progressive IDH1/2-mutant solid malignant tumors, who will be recruited to 2 cohorts: a. Cholangiocarcinoma b. Other solid malignant tumors. SECONDARY OBJECTIVES: I. To assess the progression free survival (PFS) of olaparib and AZD6738 in adults with recurrent/progressive IDH1/2-mutant solid malignant tumors. II. To estimate the overall survival (OS) in adults with recurrent/progressive IDH1/2- mutant solid malignant tumors. III. To assess the duration of response in adults with recurrent/progressive IDH1/2-mutant solid malignant tumors. IV. To assess the safety and tolerability of the combination of olaparib and AZD6738. EXPLORATORY OBJECTIVES: I. To evaluate 2-hydroxyglutarate (2HG) concentration in plasma by mass spectrometry and correlate with treatment response. II. To evaluate 2HG levels in tumor biopsies prior to the beginning of treatment and while on therapy and correlate with treatment response. III. Correlate 2HG concentration in plasma and in tumor biopsies. IV. To evaluate deoxyribonucleic acid (DNA) double strand breaks (DSBs) as measured by mass cytometry time of flight (CyTOF)-imaging mass cytometry (IMC) in tumor biopsies before and after treatment with olaparib and AZD6738. OUTLINE: Patients receive olaparib orally (PO) twice daily (BID) on days 1-28 and ceralasertib PO once daily (QD) on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Tracking Information
- NCT #
- NCT03878095
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Navid Hafez Yale University Cancer Center LAO
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