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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 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1730
Echocardiography
2013
Completed Phase 4
~11670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cediranib Maleate
2010
Completed Phase 2
~660
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,574 Total Patients Enrolled
23 Trials studying Fallopian Tube Carcinoma
6,798 Patients Enrolled for Fallopian Tube Carcinoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,273 Total Patients Enrolled
2 Trials studying Fallopian Tube Carcinoma
621 Patients Enrolled for Fallopian Tube Carcinoma
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,207 Total Patients Enrolled

Media Library

Cediranib Maleate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02446600 — Phase 3
Fallopian Tube Carcinoma Research Study Groups: Arm II (olaparib), Arm I (platinum-based chemotherapy), Arm III (olaparib, cediranib maleate)
Fallopian Tube Carcinoma Clinical Trial 2023: Cediranib Maleate Highlights & Side Effects. Trial Name: NCT02446600 — Phase 3
Cediranib Maleate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02446600 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research build off of previous Quality-of-Life Assessments?

"Quality-of-Life Assessment was first investigated in 1997 at Spectrum Health Hospital - Butterworth Campus. So far, 3427 clinical trials have completed with 1933 more currently underway; many of these active studies are based out of Nampa, Idaho."

Answered by AI

What is Quality-of-Life Assessment designed to help alleviate?

"Quality-of-Life Assessment is a frequently used treatment for typhus. However, it can also be useful in managing kaposi's sarcoma aids related, helicobacter pylori infection, and endometritis."

Answered by AI

How does Quality-of-Life Assessment affect patients negatively or positively?

"There is some data supporting the efficacy of Quality-of-Life Assessment, as this is a Phase 3 trial. Furthermore, there are multiple rounds of data supporting safety, so our team at Power rates it a 3 on our safety scale."

Answered by AI

How many individuals are being observed in this experiment?

"No, this study is no longer active and is not currently enrolling patients. The trial was first posted on February 4th, 2016 and was most recently edited on October 22nd, 2020. On the website, there are 4063 trials actively searching for patients with carcinoma and 1933 studies for Quality-of-Life Assessment admitting patients right now."

Answered by AI

Are new volunteers currently being sought for this clinical trial?

"According to the latest information on clinicaltrials.gov, this trial is not currently looking for patients as of 10/22/2022. The study was first posted on 2/4/2016. However, there are 5996 other trials that are actively recruiting right now."

Answered by AI

What is the precedence for this type of clinical trial?

"Quality-of-Life Assessment has been researched since 1997. The Alfacell Corporation sponsored the first study, which enrolled 300 participants. After proving its efficacy in this initial study, Quality-of-Life Assessment received Phase 3 approval and is now being trialed in 1933 active studies located across 90 countries."

Answered by AI

In how many different areas is this experiment being conducted today?

"In addition to the three main recruitment sites of Saint Luke's Cancer Institute - Nampa in Nampa, Idaho, Dana-Farber Cancer Institute in Boston, Massachusetts and Weisberg Cancer Treatment Center in Farmington Hills, Michigan; this trial is also enrolling at 100 other locations."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
California
British Columbia
How old are they?
18 - 65
What site did they apply to?
UCSF Medical Center-Mission Bay
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
2016. "Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02446600.
All > Adenocarcinoma > Recurrent Ovarian Cancer
~64 spots leftby Apr 2025
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