Cediranib + Olaparib for Ovarian and Breast Cancer

Recruiting at13 trial locations

Overseen by Joyce Liu, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the combination of two drugs, cediranib maleate and olaparib, to treat patients with certain types of recurrent cancer. Cediranib maleate cuts off the blood supply to cancer cells, while olaparib stops them from repairing their DNA. The trial aims to find the best dose and see if the combination works better than using olaparib by itself. Combining cediranib, which cuts off the blood supply to cancer cells, with olaparib, which stops cancer cells from repairing their DNA, may help patients live longer without their cancer getting worse.

Research Team

Joyce Liu, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with recurrent ovarian, fallopian tube, peritoneal cancer or triple-negative breast cancer. Participants must have had platinum-based chemotherapy (for ovarian cancer), be able to monitor their blood pressure daily, and not have used certain other treatments before. They should be in good health otherwise, with a life expectancy over 6 months and no severe uncontrolled conditions.

Inclusion Criteria

Participants in the Phase II part of the trial must have a way to measure their disease according to specific guidelines.

Your total bilirubin level is within 1.5 times the normal limit at the hospital.

I am 18 years old or older.

Exclusion Criteria

Participants may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks

You have had allergic reactions to similar drugs as cediranib maleate or olaparib.

My blood pressure is well-controlled.

Treatment Details

Interventions

• Cediranib Maleate (Angiogenesis Inhibitor)
• Olaparib (PARP Inhibitor)

Trial Overview The study is testing the effectiveness of combining Cediranib Maleate and Olaparib versus using Olaparib alone in treating specific recurrent cancers. It aims to find the best dose with manageable side effects and see if this combination can better prevent cancer growth by targeting both abnormal cell proliferation and the tumor's blood supply.

Participant Groups

Group I: Arm I (cediranib maleate and olaparib) Experimental Treatment 8 Interventions

Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection on the trial. Patients may also optionally undergo a tissue biopsy on the trial.

Group II: Arm II (olaparib) Active Control 7 Interventions

Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection on the trial. Patients may also optionally undergo a tissue biopsy on the trial.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School