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PARP Inhibitor and ATR Inhibitor
ATR Inhibitor + PARP Inhibitor for Ovarian Cancer (CAPRI Trial)
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
CAPRI Trial 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.Check my eligibility
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.See study design
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.
CAPRI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CAPRI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-emergent adverse events
Response rate
Secondary outcome measures
Progression free survival
CAPRI 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
Find a Location
Who is running the clinical trial?
Myriad Genetics, Inc.Industry Sponsor
16 Previous Clinical Trials
5,303 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,605,196 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,880,783 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a whole blood transfusion in the last 120 days.My ovarian cancer is not mucinous and has been reviewed by specific universities.I am willing to have a biopsy of my tumor.I had brain metastases over a year ago, received treatment, and have been free of CNS recurrence since.I have previously taken AZD6738 or similar medications.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.I do not have any other serious illnesses, recent cancers, a weakened immune system, HIV, or take certain medications.I haven't had chemotherapy or radiotherapy in the last 3 weeks.I am allergic to AZD6738, olaparib, or their ingredients.I can care for myself and am expected to live at least 6 more months.My high-grade serous ovarian, peritoneal, or fallopian tube cancer has returned and cannot be cured with standard treatments.My cancer has a BRCA or HRD mutation.My BRCA gene status does not affect my eligibility.My kidneys, liver, and bone marrow are working well.I finished my last ovarian cancer treatment at least 3 weeks ago.I may or may not have been treated with a PARP inhibitor before.I am fully recovered from major surgery and it has been more than 4 weeks since the operation.I can swallow pills without needing to change their form.I have not had major surgery in the last four weeks.My cancer did not respond to platinum-based chemotherapy.I am 18 years old or older.I have been diagnosed with a blood disorder like MDS, AML, or something similar.I have active hepatitis.I have had a bone marrow or double cord blood transplant.I was diagnosed with brain metastases less than a year ago.My BRCA gene status is either not tested or negative.
Research Study Groups:
This trial has the following groups:- Group 1: C. Olaparib Pill + AZD6738.
- Group 2: D-2 Olaparib Pill + AZD6738.
- Group 3: D-1. Olaparib Pill + AZD6738.
- Group 4: B. Olaparib Pill + AZD6738.
- Group 5: A. Olaparib Pill + AZD6738.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has AZD6738 been tested in any other clinical trials?
"First studied in 2005 at Research Site, AZD6738 has since gone through a total of 66 completed trials. At present, there are 199 active clinical trials recruiting patients; many sites based in Philadelphia offer these treatments."
Answered by AI
Is enrollment for this trial currently open?
"The information posted on the clinicaltrials.gov website verifies that this research project is currently looking for participants, having been initially opened to enrollment back in March of 2018 and updated as recently as August 18th 2022."
Answered by AI
To what extent is the research community participating in this investigation?
"This clinical trial necessitates 86 eligible participants, who can be sourced from various locations such as the Hospital of the University of Pennsylvania in Philadelphia and Johns Hopkins School of Medicine in Baltimore."
Answered by AI
Is this investigative research a pioneering venture in its field?
"As of present, there are 199 active trials for AZD6738 dispersed in 1472 cities and 59 nations. The first clinical trial of this drug was commissioned by AstraZeneca in 2005 with 98 participants; since then, 66 further studies have been completed through Phase 1 approval."
Answered by AI
To what ailments does AZD6738 typically provide relief?
"AZD6738 is the primary treatment for advance directives, but it also has a range of applications in treating malignant neoplasm of ovary, primary peritoneal cancer and somatic hallucinations."
Answered by AI
Has the FDA given AZD6738 authorization?
"AZD6738 has been assigned a safety rating of 2, as it is currently in Phase 2 trials and there exists evidence to suggest its security but not yet any data confirming efficacy."
Answered by AI
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