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PARP Inhibitor and ATR Inhibitor

ATR Inhibitor + PARP Inhibitor for Ovarian Cancer (CAPRI Trial)

Phase 2

Waitlist Available

Led By Fiona Simpkins, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients under consideration for Cohorts A, B, C, and D, must be willing to undergo mandatory tumor biopsies (non-target lesion)

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months

Must not have

Patients who have had prior AZD6738 or other cell cycle checkpoint inhibitors

Patients with a serious cardiac condition, systolic blood pressure <90 mm Hg, or lack of recovery of prior adverse events due to prior cancer therapy to Grade ≤1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new combination of drugs to treat ovarian cancer. The drugs will be given to women who have had the disease come back after treatment. The study will look at if the combination is safe and works well.

Who is the study for?

Women over 18 with recurrent ovarian cancer, either platinum-sensitive or resistant, can join. They must have good kidney and liver function, a certain level of fitness (ECOG 0 or 1), and a life expectancy over six months. Participants need measurable disease by RECIST v1.1 standards and may require specific BRCA mutation statuses depending on the cohort they're in.

What is being tested?

The trial tests AZD6738 combined with Olaparib pills in women with recurrent ovarian cancer to check safety, tolerability, response rate to treatment, and time without disease progression. It includes different cohorts based on sensitivity to platinum-based chemotherapy.

What are the potential side effects?

Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, kidney or liver issues due to drug toxicity. Specific side effects for each drug will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to have a biopsy of my tumor.

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I can care for myself and am expected to live at least 6 more months.

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My high-grade serous ovarian, peritoneal, or fallopian tube cancer has returned and cannot be cured with standard treatments.

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I can swallow pills without needing to change their form.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously taken AZD6738 or similar medications.

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I don't have serious heart issues, my blood pressure is above 90 mm Hg, and any side effects from previous cancer treatments are mild.

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I haven't had chemotherapy or radiotherapy in the last 3 weeks.

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I am allergic to AZD6738, olaparib, or their ingredients.

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I have not had major surgery in the last four weeks.

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I have been diagnosed with a blood disorder like MDS, AML, or something similar.

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I have active hepatitis.

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I have had a bone marrow or double cord blood transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of treatment-emergent adverse events

Response rate

Secondary study objectives

Progression free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: D-2 Olaparib Pill + AZD6738.Experimental Treatment2 Interventions

Cohort D Part II: Patients with ovarian cancer who are PARP inhibitor (PARPi) resistant (patients who have progressed on a PARPi). Patients must be platinum-sensitive and have a germline or somatic BRCA mutation or an HRD mutation. Approximately 12 patients will be treated. All patients will receive the combination of AZD6738 and olaparib. Cohort D will take a lower dose of olaparib (100-200 mg daily for a 28-day cycle) and a higher dose of AZD6738 (160-320 mg daily for about 14 days). Three to five dosing schedules will be evaluated.

Group II: D-1. Olaparib Pill + AZD6738.Experimental Treatment2 Interventions

Cohort D Part I: Patients will be platinum sensitive/platinum resistant ovarian cancer. Patient may or may not have received prior PARPi and will be enrolled irrespective of their BRCA status. The number of subjects treated will depend on the number of dose levels explored with a minimum of 12 subjects up to 30 subjects. All patients will receive the combination of AZD6738 and olaparib. Cohort D will take a lower dose of olaparib (100-200 mg daily for a 28-day cycle) and a higher dose of AZD6738 (160-320 mg daily for about 14 days). Three to five dosing schedules will be evaluated.

Group III: C. Olaparib Pill + AZD6738.Experimental Treatment2 Interventions

Cohort C: PARP inhibitor (PARPi) resistant (subjects who have progressed on a PARPi), patients must be platinum-sensitive, and have a germline or somatic BRCA mutation or an HRD mutation. Approximately 12 subjects could be treated. All patients will receive the combination of AZD6738 and olaparib. Patients will be administered olaparib orally twice daily at 300 mg BD. Patients will be administered AZD6738 orally once daily at 160 mg on days 1 to 7. For ease of administration, the AZD6738 should be administered at the same time as one of the olaparib doses and thus with one glass of water.

Group IV: B. Olaparib Pill + AZD6738.Experimental Treatment2 Interventions

Cohort B: Recurrent platinum-resistant ovarian cancer (progression less than or equal to 6 months of the last receipt), approximately 37 patients could be treated with an interim analysis after 12 subjects. All patients will receive the combination of AZD6738 and olaparib. Patients will be administered olaparib orally twice daily at 300 mg BD. Patients will be administered AZD6738 orally once daily at 160 mg on days 1 to 7. For ease of administration, the AZD6738 should be administered at the same time as one of the olaparib doses and thus with one glass of water.

Group V: A. Olaparib Pill + AZD6738.Experimental Treatment2 Interventions

Cohort A: Recurrent platinum-sensitive ovarian cancer (progression greater than 6 months from last receipt of platinum-based chemotherapy), approximately 37 patients could be treated with an interim analysis after 17 subjects. All patients will receive the combination of AZD6738 and olaparib. Patients will be administered olaparib orally twice daily at 300 mg BD. Patients will be administered AZD6738 orally once daily at 160 mg on days 1 to 7. For ease of administration, the AZD6738 should be administered at the same time as one of the olaparib doses and thus with one glass of water.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD6738

2015

Completed Phase 2

~130

0 / 13Eligibility criteria met