Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (RADBEV)
|ClinicalTrials.gov Identifier: NCT01031381|
Recruitment Status : Completed
First Posted : December 14, 2009
Results First Posted : August 30, 2016
Last Update Posted : August 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma||Drug: RAD001 Drug: bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer An Investigator-initiated, Single-institution Trial at Magee-Womens Hospital|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||December 2014|
U.S. FDA Resources
Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal.
Other Names:Drug: bevacizumab
bevacizumab will be administered intravenously (IV) once every 14 days.
Other Name: Avastin
- Progression-free Survival (PFS) at 6-months [ Time Frame: Up to 36 months (data collection period for the cohort); Up to 6 months for participant ]The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) [ Time Frame: Within 4 weeks (28 days) of study treatment initiation (baseline) ]The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031381
|United States, Pennsylvania|
|Magee-Womens Hospital of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Robert Edwards, MD||University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division|