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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.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, 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
Secondary outcome measures
Frequency and Severity of Adverse Effects
Overall Survival
Disease
Other outcome measures
Time From Randomization to the First Non-study, Anti-cancer Treatment or Death
Time From Randomization to the Second Non-study, Anti-cancer Treatment or Death
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
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1720
Echocardiography
2013
Completed Phase 4
~11670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Cediranib Maleate
2010
Completed Phase 2
~660
Olaparib
2007
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,952,784 Total Patients Enrolled
23 Trials studying Fallopian Tube Carcinoma
6,798 Patients Enrolled for Fallopian Tube Carcinoma
NRG OncologyOTHER
232 Previous Clinical Trials
100,199 Total Patients Enrolled
2 Trials studying Fallopian Tube Carcinoma
621 Patients Enrolled for Fallopian Tube Carcinoma
AstraZenecaIndustry Sponsor
4,287 Previous Clinical Trials
288,619,571 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have never been treated with PARP inhibitors.I have had hormone therapy for cancer in my ovaries, peritoneum, or fallopian tubes.I can swallow pills and don't have stomach issues affecting medicine absorption.You have untreated brain metastases, certain allergies, or specific heart conditions.I am 18 years old or older.I haven't received anti-angiogenic drugs for recurrent cancer, but may have had bevacizumab initially.My blood pressure is under control.I can check and record my blood pressure every day.My cancer responded completely to platinum therapy without getting worse.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.I have a history of cancer, heart issues, or specific surgeries.I do not have an uncontrolled illness, am not pregnant, HIV-negative, and do not use excluded medications.My cancer is sensitive to platinum and is a specific type with a known harmful BRCA mutation.My condition did not worsen for over 6 months after my last platinum-based treatment.I have had one non-platinum treatment for my cancer recurrence, not counting hormone therapy.I have not had treatments targeting blood vessel growth in cancer.My first cancer treatment included platinum-based drugs.I have not had a bone marrow or cord blood transplant.I have had one or more platinum-based treatments for cancer recurrence.My blood, kidney, liver, and metabolic functions meet the required health standards.I can care for myself and am up more than 50% of my waking hours.My thyroid function is normal, with no symptoms of dysfunction.I am not on medication that could significantly harm my kidneys.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (olaparib)
- Group 2: Arm I (platinum-based chemotherapy)
- Group 3: Arm III (olaparib, cediranib maleate)
Awards:
This trial has 2 awards, including:- 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.
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.
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