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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PHASE I: Participants must have histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal serous cancer, fallopian tube cancer, or triple-negative breast cancer
Breast cancer patients must have recurred post both an Adriamycin- and taxane-containing regimen
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upadverse events monitored for 3 years, mortality assessed up to 5 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Fallopian Tube Cancer
- Ovarian Cancer
- Ovarian Adenocarcinoma
- Breast Cancer
- Peritoneal Serous Adenocarcinoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with a specific type of cancer called epithelial ovarian cancer, primary peritoneal serous cancer, fallopian tube cancer, or triple-negative breast cancer.
Select...
You have breast cancer that has come back after treatment with both Adriamycin and taxane.
Select...
You have a type of ovarian, peritoneal, or fallopian tube cancer that is high-grade and has a specific genetic mutation, or you have a high-grade histology of these cancers and also carry a specific genetic mutation.
Select...
You have been diagnosed with a specific type of cancer that starts in the ovaries, fallopian tubes, or lining of the abdomen.
Select...
If you have ovarian cancer, primary peritoneal, or fallopian tube cancer, you must have either visible tumors or high levels of a cancer marker called CA125. These must be confirmed by two separate tests taken within three months, with at least one test taken within a week before starting treatment. If you only have high CA125 levels, you will be monitored using different criteria than if you have visible tumors.
Select...
You must have a disease that can be measured using a standard method called RECIST 1.1.
Select...
If you have breast cancer, your disease must be measurable according to specific criteria called RECIST.
Select...
If you have ovarian cancer and have received chemotherapy before, your treatment must have included a platinum-based medication as the first option.
Select...
You have not received a certain type of drug called a PARP-inhibitor for your cancer before, except for a specific one called BSI-201 (iniparib).
Select...
It's okay if you have received hormone-based therapy for ovarian, primary peritoneal serous, fallopian tube cancer, or breast cancer before.
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%
Hypomagnesemia
19%
Alanine Aminotransferase Increased
19%
Hypoalbuminemia
19%
Hypokalemia
17%
Dry Mouth
17%
Hyperglycemia
15%
Dyspnea
15%
Alkaline Phosphatase Increased
15%
Hypocalcemia
13%
Myalgia
10%
Dizziness
10%
Voice Alteration
10%
Oral Pain
10%
Dehydration
8%
Hoarseness
8%
Palmar-Plantar Erythrodysesthesia Syndrome
8%
Neoplasms Benign, Malignant And Unspecified (Incl
8%
Arthralgia
8%
Dyspepsia
8%
Neutrophil Count Decreased
8%
Back Pain
8%
Anxiety
6%
Cough
6%
Generalized Muscle Weakness
6%
Thromboembolic Event
6%
Dry Skin
6%
Insomnia
6%
Tinnitus
6%
Blurred Vision
6%
Fever
6%
Bruising
6%
Hypoglycemia
4%
Flatulence
4%
Skin And Subcutaneous Tissue Disorders - Other
4%
Rash Maculo-Papular
4%
Upper Respiratory Infection
4%
Dysgeusia
4%
Alopecia
4%
Abdominal Distension
4%
Fecal Incontinence
4%
Epistaxis
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%
Vaginal Hemorrhage
2%
Gastric Hemorrhage
2%
Blood Bilirubin Increased
2%
Reversible Posterior Leukoencephalopathy Syndrome
2%
Blood And Lymphatic System Disorders - Other
2%
Hemoglobin Increased
2%
Cholesterol High
2%
Chest Wall Pain
2%
Breast Pain
2%
Allergic Rhinitis
2%
Pruritus
2%
Bullous Dermatitis
2%
Hypotension
2%
Rectal Pain
2%
Esophageal Pain
2%
General Disorders And Administration Site Conditio
2%
Gallbladder Pain
2%
Lymphocyte Count Decreased
2%
Pain In Extremity
2%
Pleuritic Pain
2%
Multi-Organ Failure
2%
Urinary Tract Obstruction
2%
Ascites
2%
Edema Face
2%
Gait Disturbance
2%
Muscle Weakness Lower Limb
2%
Acute Kidney Injury
2%
Nasal Congestion
2%
Acidosis
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%
Middle Ear Inflammation
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Biopsy
2014
Completed Phase 4
~1180
Echocardiography
2013
Completed Phase 4
~11670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Computed Tomography
2017
Completed Phase 2
~2890
Biospecimen Collection
2004
Completed Phase 1
~1540
Cediranib Maleate
2010
Completed Phase 2
~660
Olaparib
2017
Completed Phase 4
~1430
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,264,722 Total Patients Enrolled
Joyce F LiuPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
693 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have ovarian cancer and have received chemotherapy before, your treatment must have included a platinum-based medication as the first option.You have not received a certain type of drug called a PARP-inhibitor for your cancer before, except for a specific one called BSI-201 (iniparib).You may not be eligible if you have had cancer in the past.You have certain heart-related risks or conditions.You have an ongoing and uncontrolled health condition.You are currently pregnant or breastfeeding.You cannot use natural herbal products or traditional remedies while in the study.You have been diagnosed with a specific type of cancer called epithelial ovarian cancer, primary peritoneal serous cancer, fallopian tube cancer, or triple-negative breast cancer.You have breast cancer that has come back after treatment with both Adriamycin and taxane.You have a type of ovarian, peritoneal, or fallopian tube cancer that is high-grade and has a specific genetic mutation, or you have a high-grade histology of these cancers and also carry a specific genetic mutation.You have been diagnosed with a specific type of cancer that starts in the ovaries, fallopian tubes, or lining of the abdomen.If you have ovarian cancer, primary peritoneal, or fallopian tube cancer, you must have either visible tumors or high levels of a cancer marker called CA125. These must be confirmed by two separate tests taken within three months, with at least one test taken within a week before starting treatment. If you only have high CA125 levels, you will be monitored using different criteria than if you have visible tumors.You must have a disease that can be measured using a standard method called RECIST 1.1.If you have breast cancer, your disease must be measurable according to specific criteria called RECIST.You cannot have participated in another research study or taken any experimental medications in the past 4 weeks. You also cannot have received any previous treatments that affect the VEGF pathway for your recurrent condition.You have cancer that has spread to your brain or spinal cord, and it has not been treated yet. Or, there are signs of it causing symptoms.It's okay if you have received hormone-based therapy for ovarian, primary peritoneal serous, fallopian tube cancer, or breast cancer before.
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 cancere 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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