A Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Renal Cell CarcinomaKidney Cancer
Interventions
DRUG

RAD001, Sunitinib

Patients will start treatment with Sunitinib and RAD001 on Cycle 1, Day 1. Sunitinib will be given orally daily for 4 weeks followed by a 2 week rest period. RAD001 will be given orally daily or weekly in subsequent cohorts with the first treatment on day 1. DLT determination will be based on toxicities observed in Cycles 1 - a cycle being defined by Sunitinib dosing. Once the MTD for the combination has been identified, a total of 10 patients will be enrolled into the study at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs

Trial Locations (1)

10021

Memorial Sloan-Kettering Cancer Center 1275 York Avenue, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00422344 - A Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma | Biotech Hunter | Biotech Hunter