Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cā¦ (NCT03462342) | Clinical Trial Compass
CompletedPhase 2
Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer
United States123 participantsStarted 2018-03-09
Plain-language summary
Investigational agent, AZD6738 will be given in combination with Olaparib to women with recurrent ovarian cancer (platinum-sensitive or platinum-resistant).
This study will determine if using Olaparib in combination with AZD6738 is safe and tolerable and also determine the objective response rate and progression free survival of combination of AZD6738 and Olaparib in women with recurrent ovarian cancer in distinct platinum-sensitive and platinum-resistant cohorts.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
ā. Patients ā„ 18 years of age
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
ā. For Cohorts A-C, and Cohort D, Part II, patients must have high grade serous ovarian, primary peritoneal, and/or fallopian tube cancer histologically or cytologically confirmed that is recurrent and for which standard curative measures do not exist or are no longer effective. For Cohort D, Part I, patients may have any non-mucinous epithelial ovarian cancer (including histologies such as clear cell, or endometrioid). Pathology must be reviewed internally at the University of Pennsylvania, Johns Hopkins University, or Harvard University prior to initiation of treatment.
ā. All patients under consideration for Cohorts A, B, C, and D, must be willing to undergo mandatory tumor biopsies (non-target lesion). Patients should have at least one lesion (non-target) for biopsy. However, for patients in Cohorts A, B, C, and D, if patients are found to not have a safe lesion to biopsy by the radiology team, they may still be enrolled in the study and forego the biopsy. Patients who undergo attempted biopsies that are unsuccessful may still enroll and receive study drug.
ā. All patients must have a measurable disease by RECIST v1.1.
ā. Germline BRCA mutation status:
ā. Adequate renal function, defined as measured creatinine clearance ā„ 51 ml/min.
ā. Adequate hepatic function, defined as AST and ALT levels ā¤ 2.5 X ULN (for subjects with liver metastases, AST or ALT ā¤ 5 Ć ULN) and total bilirubin \< 1.5 X ULN, absent Gilbert's disease.
ā. Patients with known brain metastases diagnosed within one year will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
ā. Patients who have had prior AZD6738 or other cell cycle checkpoint inhibitors such as other ATM or ATR inhibitor, WEE-1 inhibitor, or CHK1 (or 1/2) inhibitors.
ā. Patients with a serious cardiac condition, such as congestive heart failure; New York Heart Association Class III/IV heart disease; unstable angina pectoris; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment. Resting ECG with QTc \> 470 msec on two or more time points within a 24-hour period or family history of long QT syndrome.
ā. Patients with a systolic blood pressure \<90 mm Hg at two consecutive visits or recurrent symptomatic orthostatic hypotension.
ā. Lack of recovery of prior adverse events due to prior cancer therapy to Grade ā¤1 (NCI CTCAE v5.0; except alopecia). Stable persistent Grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the PI. Patients with platinum-related hypomagnesemia (on replacement) will be eligible.
ā. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, clinically significant GI bleeding or hemoptysis within 28 days prior to the start of the study, or psychiatric illness/social situations that would limit compliance with study requirements.
ā. Another previous, active or current invasive malignancy within the last five years, with the exception of curatively treated stage IA cervical carcinoma, or resected stage IA, Grade 1 endometrial cancer, noninvasive non-melanoma skin cancers, DCIS of the breast or other solid tumors including lymphomas (without bone marrow involvement). Patients with localized breast cancer who are disease free at least three years out from treatment may be eligible.
ā. Immunocompromised patients or HIV-positive patients on HAART due to potential drug interaction.