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Spots Global Cancer Trial Database for Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer

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Trial Identification

Brief Title: Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer

Official Title: A Single Arm, Open-label, Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib Tablets in Women With Recurrent Platinum Resistant Epithelial Ovarian Cancer, Including Fallopian Tube and/or Primary Peritoneal Cancer Who do Not Carry a Deleterious or Suspected Deleterious Germline BRCA Mutation

Study ID: NCT02889900

Study Description

Brief Summary: This is an open label, single arm, multi-center study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in platinum-resistant relapsed high grade serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal carcinoma patients who have received at least 3 prior lines of chemotherapy and who do not carry deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutations.

Detailed Description: The study will recruit approximately 60 patients aged ≥18 years, with histologically proven diagnosis of platinum-resistant relapsed high grade serous, high grade endometroid or clear cell ovarian, fallopian tube or primary peritoneal carcinoma who have received at least 3 prior lines of therapy, and who do not carry a deleterious or suspected deleterious germline BRCA mutation. All patients should have recurrent platinum resistant disease. The receipt of prior antiangiogenic treatment (e.g. bevacizumab) is optional. If used, it can be in the first line or recurrent setting. To be eligible to enter the study, all patients should have measurable disease (as assessed by the Investigator). There is no maximum duration for taking the study treatments (cediranib+olaparib). Patients should continue on study treatments until objective radiological disease progression, as defined by RECIST version 1.1 guidelines, or they meet other discontinuation criteria. Following discontinuation of study treatment patients will be followed for disease progression (if they have not already progressed), survival and post-progression anti cancer therapies until the data cut-off for the primary analysis, approximately 8 months after enrollment of the last patient.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Research Site, Mobile, Alabama, United States

Research Site, Anchorage, Alaska, United States

Research Site, Downey, California, United States

Research Site, Greenbrae, California, United States

Research Site, Orange, California, United States

Research Site, San Diego, California, United States

Research Site, San Francisco, California, United States

Research Site, West Hollywood, California, United States

Research Site, Miami, Florida, United States

Research Site, Miami, Florida, United States

Research Site, Orlando, Florida, United States

Research Site, Augusta, Georgia, United States

Research Site, Newnan, Georgia, United States

Research Site, Fort Wayne, Indiana, United States

Research Site, Westwood, Kansas, United States

Research Site, Covington, Louisiana, United States

Research Site, Towson, Maryland, United States

Research Site, Boston, Massachusetts, United States

Research Site, Billings, Montana, United States

Research Site, New York, New York, United States

Research Site, Rochester, New York, United States

Research Site, Charlotte, North Carolina, United States

Research Site, Winston-Salem, North Carolina, United States

Research Site, Knoxville, Tennessee, United States

Research Site, Seattle, Washington, United States

Contact Details

Name: Jung-Min Lee, M.D.

Affiliation: NIH - National Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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