Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (RADBEV)
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|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|
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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|