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Angiogenesis Inhibitor
Cediranib + Olaparib for Ovarian and Breast Cancer
Phase 1 & 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
Age >= 18 years
Breast cancer patients must have recurred post both an Adriamycin- and taxane-containing regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adverse events monitored for 3 years, mortality assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two drugs, cediranib and olaparib, compared to olaparib alone, in treating patients with recurrent ovarian, fallopian tube, peritoneal, or triple-negative breast cancer.
Who is the study for?
This trial is for adults with recurrent ovarian, fallopian tube, peritoneal cancer or triple-negative breast cancer. Participants must have had platinum-based chemotherapy (for ovarian cancer), be able to monitor their blood pressure daily, and not have used certain other treatments before. They should be in good health otherwise, with a life expectancy over 6 months and no severe uncontrolled conditions.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining Cediranib Maleate and Olaparib versus using Olaparib alone in treating specific recurrent cancers. It aims to find the best dose with manageable side effects and see if this combination can better prevent cancer growth by targeting both abnormal cell proliferation and the tumor's blood supply.See study design
What are the potential side effects?
Potential side effects include high blood pressure from Cediranib Maleate affecting blood vessels; gastrointestinal issues due to absorption requirements; fatigue; possible organ inflammation; risk of developing myelodysplastic syndrome or acute myelogenous leukemia; allergic reactions similar to those caused by related compounds.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My breast cancer returned after treatments with Adriamycin and taxane.
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Side effects from my previous cancer treatment are mild or gone, except for hair loss.
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I agree to use birth control during and 3 months after the study.
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My ovarian cancer treatment included platinum-based chemotherapy.
Select...
My kidney function is within the normal range.
Select...
My cancer is measurable or my CA125 levels are high.
Select...
I am fully active or able to carry out light work.
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I can take pills and don't have stomach issues that affect medication absorption.
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I have been diagnosed with a specific type of ovarian, fallopian tube, peritoneal, or triple-negative breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ adverse events monitored for 3 years, mortality assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse events monitored for 3 years, mortality assessed 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
Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I)
Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II)
The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T).
+1 moreSecondary outcome measures
Number of Participants With Treatment-related Toxicities of the Combination of Cediranib Maleate and Olaparib (Phase I)
Number of Participants With Treatment-related Toxicities of the Combination of Cediranib and Olaparib (Tablet Formulation) in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T).
Overall Survival (Phase II)
+1 moreSide effects data
From 2016 Phase 2 trial • 53 Patients • NCT0113282081%
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (cediranib maleate and olaparib)Experimental Treatment8 Interventions
Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. Courses 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 on the trial. Patients may also optionally undergo a tissue biopsy on the trial.
Group II: Arm II (olaparib)Active Control7 Interventions
Patients receive olaparib PO BID on days 1-28. Courses 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 on the trial. Patients may also optionally undergo a tissue biopsy on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biopsy
2014
Completed Phase 4
~850
Echocardiography
2013
Completed Phase 4
~11670
Computed Tomography
2017
Completed Phase 2
~2720
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
40,932,998 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Joyce F LiuPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
691 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to similar drugs as cediranib maleate or olaparib.Participants in the Phase II part of the trial must have a way to measure their disease according to specific guidelines.Your total bilirubin level is within 1.5 times the normal limit at the hospital.I am 18 years old or older.My breast cancer returned after treatments with Adriamycin and taxane.Side effects from my previous cancer treatment are mild or gone, except for hair loss.I had skin, breast, or cervical cancer but it was treated early and did not spread.Your AST and ALT levels in your blood are not more than 2.5 times the normal limit.My kidney function is within the normal range.I am at high risk for heart problems and need close heart monitoring.My blood pressure is well-controlled.My tests do not show signs of MDS or AML.I do not have untreated brain metastases or symptoms from brain or spinal cord tumors.I do not have HIV due to potential drug interactions.My cancer can be measured by scans or I have high CA125 levels.I agree to use birth control during and 3 months after the study.My ovarian cancer treatment included platinum-based chemotherapy.I have not taken anti-angiogenic drugs for my recurrent or metastatic cancer.I can check and record my blood pressure every day.I haven't had chemotherapy or radiotherapy in the last 3 weeks, or 6 weeks for specific drugs, and have recovered from any side effects.I do not use herbal products or folk remedies.I am not pregnant, as the treatment could harm my unborn baby.My cancer is measurable or my CA125 levels are high.Your white blood cell count is not too low.You are expected to live for at least 6 more months.I am fully active or able to carry out light work.I can take pills and don't have stomach issues that affect medication absorption.I am not taking strong medication that affects liver enzyme CYP3A4.You have low levels of protein in your urine on two separate tests taken at least a week apart, or a specific ratio of protein to creatinine in your urine.Your troponin T or I levels are within the normal range at the hospital where you are being treated.Your blood clotting tests (INR, aPTT) are within a certain range, unless you have a confirmed Lupus anticoagulant.You have enough platelets in your blood (at least 100,000 per microliter).Your hemoglobin level is higher than 9 grams per deciliter.I have been diagnosed with a specific type of ovarian, fallopian tube, peritoneal, or triple-negative breast cancer.I have not taken PARP inhibitors for my recurrent or metastatic cancer.To put it simply, this criterion means that the researchers are looking for patients who do not have any of the conditions listed.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (olaparib)
- Group 2: Arm I (cediranib maleate and olaparib)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What clinical applications is Cediranib Maleate most commonly used for?
"Cediranib Maleate is primarily prescribed for advanced directives, as well as malignant neoplasms of the ovary, primary peritoneal cancer, and hallucinations experienced by somatic individuals."
Answered by AI
Are participants still welcome to join this clinical exploration?
"This experiment is not presently accepting new enrollees. It was first posted on March 25th, 2010 and the most recent update to the trial details occurred on November 12th of 2022. For those looking for additional tests relevant to their condition, there are 6008 studies actively recruiting participants with high grade ovarian serous adenocarcinoma and 193 trials utilizing Cediranib Maleate as an intervention that require participation."
Answered by AI
Could you provide an overview of all the research conducted with Cediranib Maleate?
"Presently, 193 investigations into Cediranib Maleate are live with 27 in the latter phase of clinical trials. The most prolific center is located in Houston, Texas yet there are also 9498 other medical sites executing studies for this medication."
Answered by AI
Is this a pioneering clinical trial?
"Since its Phase 1 approval in 2005, the drug Cediranib Maleate has been studied for 193 times across 59 nations and 1486 cities. This medication was first trialed by AstraZeneca with 98 participants, and since then 110 subsequent studies have taken place."
Answered by AI
What is the uppermost limit of participants for this research endeavor?
"This clinical trial is no longer actively enrolling individuals. It was initially posted on March 25th 2010 and its latest edition occurred on November 12th 2022. Currently, there are 6008 studies recruiting patients with high grade ovarian serous adenocarcinoma and 193 trials for Cediranib Maleate that require participants."
Answered by AI
What is the projected outcome of this research endeavor?
"This clinical trial, which will span a period of 28 days, aims to identify the Maximum Tolerated Dose (MTD) for combining cediranib and olaparib in treating recurrent ovarian cancer, fallopian tube cancer or peritoneal cancer or metastatic triple-negative breast cancer. Secondary objectives include evaluating overall survival with Kaplan Meier analysis & log rank tests for between group comparison; determining treatment related toxicities from this combination via National Cancer Institute Common Terminology Criteria version 4.0; and calculating tumour response rate through Response Evaluation Criteria In Solid Tumors (RECIST)."
Answered by AI
How many facilities are offering this trial's services?
"Currently, 14 different clinics are hosting this clinical trial. Participating cities include Fort Wayne, Boston and Charlestown as well as 11 additional sites. To minimize the burden of travel during enrollment, it is advised to select a clinic nearby your current location."
Answered by AI
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