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Tyrosine Kinase Inhibitor

Olaparib vs. Cediranib + Olaparib for Recurrent Ovarian Cancer

Phase 3

Waitlist Available

Led By Joyce F Liu

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease or evaluable disease and a cancer antigen 125 (CA125) that has doubled from the post-treatment nadir and is also greater than 2 times upper limit of normal (ULN)

Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib or olaparib

Must not have

No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 30 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two different treatments for ovarian, fallopian tube, or primary peritoneal cancer that has come back. One treatment is a standard chemotherapy treatment, and the other is a new treatment that uses two drugs, olaparib and cediranib maleate. The trial will see if the new treatment is more effective than the standard chemotherapy treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, high blood pressure from Cediranib, and gastrointestinal symptoms. Individual reactions may vary based on personal health conditions.

Eligibility Criteria

Inclusion Criteria

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

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

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I can swallow pills and don't have stomach issues affecting medicine absorption.

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I am 18 years old or older.

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My cancer is sensitive to platinum and is a specific type with a known harmful BRCA mutation.

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My cancer responded completely to platinum therapy without getting worse.

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I can check and record my blood pressure every day.

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My first cancer treatment included platinum-based drugs.

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I can care for myself and am up more than 50% of my waking hours.

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My thyroid function is normal, with no symptoms of dysfunction.

Exclusion Criteria

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

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I have not had a bone marrow or cord blood transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria

Secondary study objectives

Frequency and Severity of Adverse Effects

Overall Survival

Disease

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (olaparib, cediranib maleate)Experimental Treatment10 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 Treatment9 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 Control11 Interventions

See detailed description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Multigated Acquisition Scan

2015