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Tyrosine Kinase Inhibitor

Cediranib + Olaparib for Recurrent Ovarian Cancer

Phase 2 & 3

Waitlist Available

Led By Jung-min Lee

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

Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is not available tumor sample from fresh biopsy is acceptable

Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from study enrollment to the onset of progression as determined by response evaluation criteria in solid tumors version 1.1 (recist) criteria, or death due to any cause, whichever occurs first, assessed up to 5 years

Awards & highlights

Study Summary

This trial is testing two drugs, cediranib and olaparib, to see if they work better than standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after treatment or continued to grow during treatment.

Who is the study for?

This trial is for adults with recurrent ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based chemotherapy. Participants must not have used anti-angiogenic agents or PARP-inhibitors before and should be able to take oral medications. They need a good performance status (ECOG 0-2), controlled blood pressure and thyroid function, no severe cardiac history or untreated brain metastases, and can't be HIV-positive or pregnant.Check my eligibility

What is being tested?

The study tests if cediranib maleate combined with olaparib is more effective than each drug alone or standard chemotherapy in treating certain cancers. It examines how these drugs block enzymes needed for tumor growth versus how chemo stops cell division/spread. The trial includes imaging tests like CT and MRI to monitor the disease.See study design

What are the potential side effects?

Potential side effects include gastrointestinal issues due to oral medication intake, high blood pressure requiring control measures, possible impact on thyroid function needing monitoring, as well as general risks associated with taking cancer treatment drugs such as fatigue, nausea, and increased risk of infection.

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 and I can provide a recent or new biopsy sample if needed.

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I have been diagnosed with ovarian, peritoneal, or fallopian tube cancer.

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I can take pills and don’t have stomach issues affecting medicine absorption.

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I do not have untreated brain tumors or symptoms from brain or spinal cord tumors.

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I can take care of myself but may not be able to do heavy physical work.

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I do not have HIV.

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I am 18 years old or older.

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I am not taking any strong medication that affects liver enzymes.

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I do not have signs of MDS or AML.

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

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I have no history of heart conditions.

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I have had 3 or fewer previous cancer treatments.

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My cancer has returned and does not respond well to platinum-based treatments.

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My blood pressure is under control.

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I do not use herbal or alternative medicines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from study enrollment to the onset of progression as determined by response evaluation criteria in solid tumors version 1.1 (recist) criteria, or death due to any cause, whichever occurs first, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from study enrollment to the onset of progression as determined by response evaluation criteria in solid tumors version 1.1 (recist) criteria, or death due to any cause, whichever occurs first, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from study enrollment to the onset of progression as determined by response evaluation criteria in solid tumors version 1.1 (recist) criteria, or death due to any cause, whichever occurs first, assessed 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

Overall survival (OS) (Phase III)

Progression-free survival (PFS) (Phase II and Phase III)

Secondary outcome measures

Incidence of adverse events (Phase II and Phase III)

Objective response rate (partial or complete response) (Phase II and Phase III)

Other outcome measures

Biomarkers in plasma angiome

Change in circulating endothelial cell levels

Gene mutations assessed BROCA-HR

+1 more

Side effects data

From 2015 Phase 2 & 3 trial • 1814 Patients • NCT00384176

77%

Diarrhoea

52%

Nausea

48%

Hypertension

47%

Fatigue

45%

Neutropenia

40%

Stomatitis

37%

Decreased Appetite

34%

Vomiting

29%

Thrombocytopenia

26%

Neuropathy Peripheral

26%

Abdominal Pain

25%

Dysphonia

24%

Headache

24%

Epistaxis

24%

Paraesthesia

19%

Peripheral Sensory Neuropathy

18%

Constipation

17%

Weight Decreased

16%

Palmar-Plantar Erythrodysaesthesia Syndrome

16%

Asthenia

14%

Dyspnoea

14%

Pyrexia

13%

Dysgeusia

13%

Hypothyroidism

12%

Cough

12%

Proteinuria

11%

Abdominal Pain Upper

11%

Nasopharyngitis

10%

Leukopenia

10%

Back Pain

Alopecia

Pain In Extremity

Dizziness

Hypokalaemia

Anaemia

Insomnia

Urinary Tract Infection

Arthralgia

Oropharyngeal Pain

Rash

Oedema Peripheral

Depression

Lethargy

Alanine Aminotransferase Increased

Myalgia

Dysphagia

Dyspepsia

Drug Hypersensitivity

Dry Mouth

Phlebitis

Musculoskeletal Pain

Dehydration

Pulmonary Embolism

Upper Respiratory Tract Infection

Gastrointestinal Pain

Vena Cava Thrombosis

Left Ventricular Dysfunction

Cerebral Haemorrhage

Abdominal Abscess

Pleural Effusion

Non-Cardiac Chest Pain

Pharyngeal Oedema

Pneumonia

Catheter Related Infection

Agranulocytosis

Oesophagitis

Angina Pectoris

Intestinal Perforation

Atrial Flutter

Supraventricular Tachycardia

Ileus

Rectal Haemorrhage

Hypercalcaemia

General Physical Health Deterioration

Embolism Venous

Lobar Pneumonia

Abdominal Infection

Sepsis

Transient Ischaemic Attack

Haematuria

Cerebrovascular Accident

Cognitive Disorder

Renal Failure

Convulsion

Deep Vein Thrombosis

Cardiomyopathy

Enteritis

Gastrointestinal Toxicity

Ileus Paralytic

Large Intestinal Obstruction

Appendicitis

Bronchitis

Catheter Site Cellulitis

Neutropenic Sepsis

Pulmonary Tuberculosis

Syncope

Cerebral Ischaemia

Haemorrhagic Stroke

Vascular Encephalopathy

Subclavian Vein Thrombosis

Thrombosis

Cardiopulmonary Failure

Mitral Valve Incompetence

Myocardial Ischaemia

Intestinal Haemorrhage

Bradyphrenia

Hypertensive Crisis

Febrile Neutropenia

Pancytopenia

Intestinal Obstruction

Gastrointestinal Inflammation

Large Intestine Perforation

Death

100%

80%

60%

40%

20%

Study treatment Arm

Cediranib 30 mg

1Bevacizumab 5mg/kg

Cediranib 20 mg

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Phase III Arm III (single-agent cediranib maleate)Experimental Treatment5 Interventions

Patients receive cediranib maleate PO as determined by the Phase II study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.

Group II: Phase III Arm II (cediranib maleate, olaparib)Experimental Treatment6 Interventions

Patients receive cediranib maleate PO and olaparib PO as in Phase II Arm II. Patients also undergo CT and MRI throughout the study.

Group III: Phase II Arm IV (olaparib)Experimental Treatment4 Interventions

Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).

Group IV: Phase II Arm III (cediranib maleate)Experimental Treatment5 Interventions

Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.

Group V: Phase II Arm II (cediranib maleate, olaparib)Experimental Treatment6 Interventions

Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.

Group VI: Phase III Arm I (reference regimen)Active Control7 Interventions

Patients undergo physician's choice standard of care chemotherapy as in Phase II Arm I. No modification of the assigned regimens, such as additional drugs (gemcitabine or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)

Group VII: Phase II Arm I (reference regimen)Active Control7 Interventions

Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Cediranib Maleate

2010

Completed Phase 2

~660

Olaparib

2007

Completed Phase 4

~2140

Cediranib

2016

Completed Phase 3

~4030

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER

231 Previous Clinical Trials

100,290 Total Patients Enrolled

2 Trials studying Endometrioid Adenocarcinoma

378 Patients Enrolled for Endometrioid Adenocarcinoma

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,591 Total Patients Enrolled

5 Trials studying Endometrioid Adenocarcinoma

1,224 Patients Enrolled for Endometrioid Adenocarcinoma

Canadian Cancer Trials GroupNETWORK

124 Previous Clinical Trials

66,891 Total Patients Enrolled

Media Library

Cediranib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02502266 — Phase 2 & 3

Endometrioid Adenocarcinoma Clinical Trial 2023: Cediranib Highlights & Side Effects. Trial Name: NCT02502266 — Phase 2 & 3

Cediranib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02502266 — Phase 2 & 3

Frequently Asked Questions

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

Is it possible to sign up for this research project at the current time?

"This particular trial, as of November 8th, 2022, is not looking for new patients. It was first posted on February 5th 2016 and has been updated regularly since then. Although this study isn't searching for new members right now, there are plenty of other trials (5483 in total) that are still recruiting."

Answered by AI

Are there other tests that have been run with Cediranib before?

"At this time, there are 1407 different ongoing clinical trials researching cediranib. Of these, 349 have progressed to Phase 3 testing. Cediranib is being studied most extensively in Shanghai, but there are 66844 total locations running trials for this medication globally."

Answered by AI

How many individuals are being treated within the confines of this experiment?

"Unfortunately, this particular trial is no longer seeking patients. The clinical trial was first posted on February 5th 2016 and the last update to the information was on November 8th 2022. There are currently 4076 trials actively searching for patients with fallopian tubes and 1407 trials for Cediranib that are still recruiting participants."

Answered by AI

Is this scientific research being conducted in more than one facility within the state?

"The University of Wisconsin Carbone Cancer Center in Madison, the Ascension Saint Vincent Indianapolis Hospital, and the Mission Cancer and Blood - Laurel in Des Moines are just a few of the locations where this clinical trial is taking place. In total, there are 12 sites running this study."

Answered by AI

For what purpose is Cediranib most commonly prescribed?

"Cediranib is most often used to treat advanced soft tissue sarcoma (STS), but it can also be useful in treating skin infections caused by staphylococcus aureus, carcinoma, and escherichia infections."

Answered by AI

Is this an experimental clinical trial?

"As of right now, there are 1,407 active clinical trials involving the use of cediranib in 3,466 cities across 82 countries. The very first trial began in 1997 and was completed as a Phase 3 drug approval study with 300 participants. Since that time, 2,215 studies have been wrapped up."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer

2016. "Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02502266.

All > Adenocarcinoma > Recurrent Ovarian Cancer