Phase I/II Trial of RAD001 Plus Nexavar in Patients With Kidney Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Carcinoma, Renal Cell
Interventions
DRUG

RAD001

RAD001 will be administered orally once a day, daily, without interruption per 4 wk cycle for 2 cycles. MTD is established in Phase I portion of trial (2.5, 5 or 10mg). If responding, additional therapy will be given.

DRUG

Sorafenib

A dose of 400mg of Nexavar® will be administered orally twice a day, daily, without an interruption per 4 week cycle for 2 cycles. If responding, additional therapy will be given.

Trial Locations (1)

77030

The Methodist Hospital Research Institute, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

The Methodist Hospital Research Institute

OTHER