NCT01031381

Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy as well as the safety of RAD001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be taken orally once daily and bevacizumab will be administered once every 14 days. The study will be conducted over a period of about 3 to 4 years.

Detailed description

In this trial, approximately 50 patients will receive the study drug, RAD001 in combination with bevacizumab (Avastin)chemotherapy. RAD001 will be taken orally once daily and bevacizumab will be administered intravenously once every 14 days. In addition to study treatment, a few blood samples and a sample of the patients tumor from a previous surgery if available will be collected for research.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	RAD001	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.
DRUG	bevacizumab	bevacizumab will be administered intravenously (IV) once every 14 days.

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-01-01
• Completion: 2014-12-01
• First posted: 2009-12-14
• Last updated: 2016-08-30
• Results posted: 2016-08-30

Locations

1 site across 1 country: United States