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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
Must not have
Participants may not have had prior use of PARP inhibitors; patients may not have received prior treatment affecting the VEGF pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, or sorafenib
Participants with any of the following: History of myocardial infarction within six months, Unstable angina, New York Heart Association (NYHA) classification of III or IV, Prior treatment with anthracyclines, Prior treatment with trastuzumab, Prior central thoracic radiation therapy (RT), History of myocardial infarction within 6 to 12 months, A NYHA classification of II controlled with treatment, Prior history of impaired cardiac function, History of a stroke or transient ischemic attack within six months, Clinically significant peripheral vascular disease or vascular disease, Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib, Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease, History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib, Current use of a prohibited medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Summary

This study is evaluating whether a drug called olaparib and a drug called cediranib maleate work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent).

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not used PARP inhibitors or drugs affecting the VEGF pathway for my cancer.
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Criterion: You have had a heart attack, unstable chest pain, or severe heart failure in the last six months. You have also had specific cancer treatments or surgeries within certain timeframes, or are currently dealing with certain medical conditions or medications.
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I have never had a hypertensive crisis or brain issues due to high blood pressure.
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I am not pregnant or breastfeeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) in Platinum-Resistant Ovarian Cancer
Progression-Free Survival (PFS) by HRR Status in Platinum-Sensitive Ovarian Cancer
Secondary study objectives
Biomarker Signature Development
Change in Circulating Endothelial Cells/Circulating Endothelial Precursor Cells
Genetic Alterations
+2 more
Other study objectives
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%
Hypoalbuminemia
19%
Alanine Aminotransferase Increased
19%
Hypomagnesemia
19%
Hypokalemia
17%
Dry Mouth
17%
Hyperglycemia
15%
Dyspnea
15%
Alkaline Phosphatase Increased
15%
Hypocalcemia
13%
Myalgia
10%
Dehydration
10%
Voice Alteration
10%
Dizziness
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%
Hypoglycemia
6%
Cough
6%
Thromboembolic Event
6%
Generalized Muscle Weakness
6%
Blurred Vision
6%
Insomnia
6%
Tinnitus
6%
Fever
6%
Bruising
4%
Fecal Incontinence
4%
Upper Respiratory Infection
4%
Flatulence
4%
Skin And Subcutaneous Tissue Disorders - Other
4%
Rash Maculo-Papular
4%
Alopecia
4%
Dysgeusia
4%
Epistaxis
4%
Abdominal Distension
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%
Urinary Tract Obstruction
2%
Bullous Dermatitis
2%
Middle Ear Inflammation
2%
Acidosis
2%
Gallbladder Pain
2%
Edema Face
2%
Hemoglobin Increased
2%
Acute Kidney Injury
2%
Vaginal Hemorrhage
2%
Pruritus
2%
Blood Bilirubin Increased
2%
Breast Pain
2%
Lymphocyte Count Decreased
2%
General Disorders And Administration Site Conditio
2%
Nasal Congestion
2%
Blood And Lymphatic System Disorders - Other
2%
Rectal Pain
2%
Cholesterol High
2%
Gastric Hemorrhage
2%
Ascites
2%
Esophageal Pain
2%
Gait Disturbance
2%
Muscle Weakness Lower Limb
2%
Chest Wall Pain
2%
Reversible Posterior Leukoencephalopathy Syndrome
2%
Multi-Organ Failure
2%
Pleuritic Pain
2%
Allergic Rhinitis
2%
Pain In Extremity
2%
Hypotension
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
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Computed Tomography
2017
Completed Phase 2
~2740
Echocardiography
2013
Completed Phase 4
~11580
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biopsy
2014
Completed Phase 4
~1090
Cediranib Maleate
2010
Completed Phase 2
~660
Olaparib
2007
Completed Phase 4
~2190

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Ovarian cancer treatments often include PARP inhibitors like Olaparib and VEGFR inhibitors like Cediranib Maleate. PARP inhibitors work by blocking the PARP enzyme, which helps repair DNA damage in cells. This is particularly effective in cancer cells with BRCA mutations, leading to cell death. VEGFR inhibitors, on the other hand, target the vascular endothelial growth factor receptor, which is involved in the formation of blood vessels that supply the tumor. By inhibiting this pathway, Cediranib Maleate can reduce tumor growth and spread. These targeted therapies are crucial for ovarian cancer patients as they offer a more precise treatment option, potentially leading to better outcomes and fewer side effects compared to conventional chemotherapy.
The safety of antiangiogenic agents and PARP inhibitors in platinum-sensitive recurrent ovarian cancer.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,930 Total Patients Enrolled
291 Trials studying Ovarian Cancer
74,941 Patients Enrolled for Ovarian Cancer
Joyce F LiuPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
3 Previous Clinical Trials
776 Total Patients Enrolled
~8 spots leftby Sep 2025
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