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Tyrosine Kinase Inhibitor

Cediranib + Olaparib for Ovarian Cancer

Phase 2
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
Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) less than or equal to the upper limit of normal
For platinum sensitive cohort: Cancer that has not progressed within 6 months of the last receipt of platinum-based chemotherapy, no limit on the number of platinum-based lines, and no more than one prior non-platinum based line of therapy in the recurrent setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing olaparib and cediranib maleate to see if they can treat ovarian, primary peritoneal, or fallopian tube cancer that has come back.

Who is the study for?
This trial is for adults with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Participants must have measurable disease and not have used PARP inhibitors before. They should be in good physical condition (ECOG <=2) and able to take oral medications. Those with controlled blood pressure, no recent chemotherapy or invasive cancers (with some exceptions), and no history of certain heart conditions can join.Check my eligibility
What is being tested?
The study tests the effectiveness of combining Cediranib Maleate and Olaparib in treating patients whose ovarian cancer has returned after treatment. It examines if these drugs can block enzymes needed for tumor growth, using imaging techniques like CT scans and MRIs to measure results.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, high blood pressure, bleeding risks, heart problems due to Cediranib Maleate; Olaparib might cause anemia, digestive issues, taste changes or fatigue. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My thyroid function is normal, with no symptoms of dysfunction.
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My cancer did not worsen within 6 months after my last platinum-based treatment.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function is within the normal range.
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I am willing to have biopsies before and during treatment.
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I am 18 years old or older.
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I have a tumor that can be measured with scans or exams.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) in Platinum-Resistant Ovarian Cancer
Progression-Free Survival (PFS) by HRR Status in Platinum-Sensitive Ovarian Cancer
Secondary outcome measures
Biomarker Signature Development
Change in Circulating Endothelial Cells/Circulating Endothelial Precursor Cells
Genetic Alterations
+2 more
Other outcome measures
Ecediranib-olaparib application web portal metrics
Incidence of ecediranib-olaparib application user support call
Perceived usability and satisfaction of ecediranib-olaparib application from health care professionals
+1 more

Side effects data

From 2016 Phase 2 trial • 53 Patients • NCT01132820
81%
Fatigue
69%
Diarrhea
60%
Hypertension
48%
Anorexia
46%
Nausea
35%
Anemia
33%
Weight Loss
31%
Vomiting
31%
Peripheral Sensory Neuropathy
29%
Mucositis Oral
29%
Hypothyroidism
27%
Constipation
25%
Aspartate Aminotransferase Increased
23%
Headache
23%
Abdominal Pain
23%
Platelet Count Decreased
23%
Creatinine Increased
23%
White Blood Cell Decreased
21%
Urinary Tract Infection
21%
Pain
21%
Hyponatremia
21%
Proteinuria
19%
Alanine Aminotransferase Increased
19%
Hypomagnesemia
19%
Hypoalbuminemia
19%
Hypokalemia
17%
Dry Mouth
17%
Hyperglycemia
15%
Dyspnea
15%
Alkaline Phosphatase Increased
15%
Hypocalcemia
13%
Myalgia
10%
Dizziness
10%
Dehydration
10%
Voice Alteration
10%
Oral Pain
8%
Palmar-Plantar Erythrodysesthesia Syndrome
8%
Hoarseness
8%
Neoplasms Benign, Malignant And Unspecified (Incl
8%
Arthralgia
8%
Dyspepsia
8%
Neutrophil Count Decreased
8%
Back Pain
8%
Anxiety
6%
Dry Skin
6%
Blurred Vision
6%
Thromboembolic Event
6%
Cough
6%
Generalized Muscle Weakness
6%
Hypoglycemia
6%
Insomnia
6%
Tinnitus
6%
Fever
6%
Bruising
4%
Upper Respiratory Infection
4%
Flatulence
4%
Epistaxis
4%
Skin And Subcutaneous Tissue Disorders - Other
4%
Dysgeusia
4%
Alopecia
4%
Abdominal Distension
4%
Fecal Incontinence
4%
Rash Maculo-Papular
4%
Bladder Infection
4%
Dry Eye
4%
Rectal Hemorrhage
4%
Gastroesophageal Reflux Disease
4%
Edema Limbs
4%
Inr Increased
4%
Activated Partial Thromboplastin Time Prolonged
4%
Hypophosphatemia
4%
Hypernatremia
4%
Hyperkalemia
4%
Pelvic Pain
4%
Cognitive Disturbance
2%
Acute Kidney Injury
2%
Blood Bilirubin Increased
2%
Muscle Weakness Lower Limb
2%
Cholesterol High
2%
Gallbladder Pain
2%
Hemoglobin Increased
2%
Edema Face
2%
Gait Disturbance
2%
Nasal Congestion
2%
Acidosis
2%
Vaginal Hemorrhage
2%
Breast Pain
2%
Chest Wall Pain
2%
Blood And Lymphatic System Disorders - Other
2%
Rectal Pain
2%
Lymphocyte Count Decreased
2%
Hypotension
2%
Bullous Dermatitis
2%
Urinary Tract Obstruction
2%
Pain In Extremity
2%
Multi-Organ Failure
2%
Pruritus
2%
Esophageal Pain
2%
Pleuritic Pain
2%
Gastric Hemorrhage
2%
Reversible Posterior Leukoencephalopathy Syndrome
2%
Middle Ear Inflammation
2%
Ascites
2%
General Disorders And Administration Site Conditio
2%
Allergic Rhinitis
2%
Oral Hemorrhage
2%
Peripheral Motor Neuropathy
2%
Colitis
2%
Anal Hemorrhage
2%
Oral Dysesthesia
2%
Gastrointestinal Pain
2%
Joint Range Of Motion Decreased
2%
Hematuria
2%
Vaginal Pain
2%
Confusion
2%
Death Nos
2%
Myocardial Infarction
2%
Colonic Perforation
2%
Rectal Fistula
2%
Ileal Obstruction
2%
Peritoneal Necrosis
2%
Lung Infection
2%
Chest Pain - Cardiac
2%
Sinus Tachycardia
2%
Sinus Bradycardia
2%
Vertigo
2%
Conjunctivitis
2%
Endocrine Disorders - Other
2%
Eye Disorders - Other
2%
Hyperthyroidism
2%
Dysphagia
2%
Gastric Ulcer
2%
Flu Like Symptoms
2%
Skin Infection
2%
Investigations - Other
2%
Chills
2%
Lipase Increased
2%
Syncope
2%
Neck Pain
2%
Flank Pain
2%
Intracranial Hemorrhage
2%
Memory Impairment
2%
Vaginal Dryness
2%
Depressed Level Of Consciousness
2%
Depression
2%
Skin Induration
2%
Urinary Tract Pain
2%
Respiratory Failure
2%
Hot Flashes
2%
Hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cediranib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib and cediranib maleate)Experimental Treatment9 Interventions
Patients receive olaparib PO BID and cediranib maleate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a biopsy of tumor, blood sample collection, MUGA or echocardiogram, and CT scan or MRI scan throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biopsy
2014
Completed Phase 4
~850
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
40,933,083 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Joyce F LiuPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
3 Previous Clinical Trials
776 Total Patients Enrolled

Frequently Asked Questions

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

Could you provide an overview of the past experiments involving Cediranib Maleate?

"In 2005, Cediranib Maleate was first trialled at Research Site. This drug has since been evaluated in 289 total studies, many of which are occurring simultaneously in Jacksonville, Florida. Currently 193 active investigations into this medication exist."

Answered by AI

Is there still availability for participation in this research?

"Unfortunately, this trial is not currently searching for participants. Although it was initially posted on December 4th 2015 and last updated July 1st 2022, there are 3911 studies actively recruiting patients with cystadenocarcinoma, serous as well as 193 trials for Cediranib Maleate also seeking enrollees."

Answered by AI

What risks do patients face when taking Cediranib Maleate?

"The risk analysis conducted by Power assigned a rating of 2 to Cediranib Maleate, as this is still in Phase 2 trials and has only generated data regarding safety but not efficacy."

Answered by AI

What primary purpose does this research endeavor aim to accomplish?

"The primary aim of this medical trial, assessed within 30 days post-treatment, is to gauge progression-free survival. Additional objectives include evaluating the correlation between circulating endothelial cells at baseline and progression-free survival through a paired t-test or Wilcoxon signed rank test; determining the prevalence of genetic alterations using BROCA homologous recombination assay and bioinformatics pipeline; determining if BRCA mutations (germline or somatic) are linked to/against progression free survival with Kaplan Meier product limit estimates alongside stratified logrank tests utilising a two sided alpha level of 0.05; as well as"

Answered by AI

What clinical purposes does Cediranib Maleate typically serve?

"Cediranib Maleate is the most common medication prescribed to manage advanced directives. It can also provide some benefit in cases of malignant neoplasm of ovary, primary peritoneal cancer, and hallucinations with somatic symptoms."

Answered by AI

How many medical sites are currently facilitating this clinical investigation?

"This experiment is presently hosted in twenty facilities, including centres located in Jacksonville, Phoenix and Durham. It is advised that participants select the closest trial site to limit their travel commitments should they enroll."

Answered by AI

How many participants are currently partaking in this research project?

"Unfortunately, this specific study is not currently enrolling. It was initially posted on December 4th 2015 and has most recently been refreshed on July 1st 2022. If you are in search of other trials, there are 3911 active studies recruiting participants with cystadenocarcinoma serous as well as 193 clinical trials accepting candidates for Cediranib Maleate treatment interventions."

Answered by AI

Is this an experimental clinical exploration?

"Since its initial 2005 study, sponsored by AstraZeneca with 98 participants, Cediranib Maleate has been rigorously investigated and subsequently approved for Phase 1 drug trials. To date, 193 active experiments are being conducted in 1486 cities across 59 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer
2016. "Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02345265.
All > Adenocarcinoma > Recurrent Ovarian Cancer
~8 spots leftby Apr 2025
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