NCT00591734

RAD001 Plus Bevacizumab in Metastatic Melanoma

A Phase II Trial of RAD001 Plus Bevacizumab in the Treatment of Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma.

Detailed description

All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients will receive 6 weeks of treatment, followed by re evaluation. Patients with objective response or stable disease will continue treatment until disease progression. During the study, all patients will receive 10 mg of RAD001 orally daily and 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks. Fifty-five patients will be enrolled in this multi-centered study

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.
DRUG	Everolimus	10 mg by mouth daily

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-10-01
• Completion: 2011-10-01
• First posted: 2008-01-11
• Last updated: 2021-11-24
• Results posted: 2013-02-26

Locations

15 sites across 1 country: United States