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Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer | Clinical Trials | Clareo Health

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Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer

Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD 6738 and Olaparib in Recurrent Ovarian Cancer

NCT03462342•University of Pennsylvania

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•For inclusion in the study, patients must fulfill the following criteria:
•1. Patients ≥ 18 years of age
•2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
•3. 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.
•4. 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.
•5. All patients must have a measurable disease by RECIST v1.1.
•6. Germline BRCA mutation status:
•* Cohorts A and B: Patients with unknown BRCA status or negative BRCA germline mutation status will be permitted to enroll in the study. Patients with known BRCA germline mutations will be permitted to enroll up to a maximum of 10 subjects per cohort.
•* Cohort C and Cohort D Part II: All subjects must have either a germline or somatic BRCA mutation, or other HRD mutation, or tumor is HRD positive. Other HRD mutations will be reviewed for consideration for enrollment by study review committee or University of Pennsylvania principal investigator.
•* Cohort D Part I: Patients will be enrolled irrespective of BRCA status.
+24 more criteria

Exclusion Criteria

•1. 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.
•2. 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.
•3. 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.
•4. Patients with a systolic blood pressure \<90 mm Hg at two consecutive visits or recurrent symptomatic orthostatic hypotension.
•5. Lack of recovery of prior adverse events due to prior cancer therapy to Grade ≤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.
•6. 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.
•7. 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.
•8. Immunocompromised patients or HIV-positive patients on HAART due to potential drug interaction.
•9. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is two weeks.
•10. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is five weeks for enzalutamide or phenobarbital and three weeks for other agents.
+8 more criteria

Locations (3)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 9, 2018

Primary Completion Date

July 21, 2025

Completion Date

July 21, 2025

Last Updated

March 17, 2026

Enrollment

123

ACTUAL participants

Conditions

High Grade Serous Carcinoma

Interventions

Olaparib Pill

DRUG

AZD6738

DRUG

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BRCA1 MutationBRCA2 Mutation+3 more

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UNKNOWN

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High Grade Serous CarcinomaOvarian Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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