Olaparib vs. Cediranib + Olaparib for Recurrent Ovarian Cancer

Recruiting at 400 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Research Team

Joyce F Liu

Principal Investigator

NRG Oncology

Eligibility Criteria

Women aged 18+ with platinum-sensitive high-grade ovarian, fallopian tube, or primary peritoneal cancer that responded well to initial platinum-based therapy. Must not have used PARP inhibitors before, can manage daily blood pressure checks, and agree to use two forms of contraception. No recent chemotherapy/radiotherapy or investigational drugs within the past month.

Inclusion Criteria

I have not taken PARP inhibitors for my ovarian, peritoneal, or fallopian tube cancer.

I have a specific type of ovarian cancer and a positive test for BRCA mutation.

My cancer can be measured by scans or has a high CA125 level.

Exclusion Criteria

You have untreated brain metastases, certain allergies, or specific heart conditions.

I haven't had chemotherapy or radiotherapy in the last 4-6 weeks and have recovered from any side effects.

I have never taken PARP inhibitor medications.

Treatment Details

Interventions

• Cediranib Maleate (Tyrosine Kinase Inhibitor)
• Olaparib (PARP Inhibitor)

Trial Overview The trial compares the effectiveness of Olaparib alone or combined with Cediranib against standard platinum-based chemotherapy in treating recurrent cancers. It examines if these drugs can better inhibit tumor growth by blocking enzymes and blood vessel formation necessary for tumors.

Participant Groups

Group I: Arm III (olaparib, cediranib maleate) Experimental Treatment 10 Interventions

Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles 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 throughout the trial.

Group II: Arm II (olaparib) Experimental Treatment 9 Interventions

Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

Group III: Arm I (platinum-based chemotherapy) Active Control 11 Interventions

See detailed description.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology