Renal Cell Carcinoma Clinical Trial
Official title:
A Phase I Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma Patients
The purpose of this study is to test the safety of RAD-001 and Sunitinib given in
combination for renal cell cancer. We also want to find out what effects (good and bad) the
combination of RAD-001 and Sunitinib have on you and your tumor.
RAD001 is a pill that works by shutting down some of the pathways in the cell that make
tumors grow. Sunitinib is a pill that works by shutting off the signal in the cancer cells
that tell the cells to grow blood vessels. Without this signal, the blood vessels to the
tumors shrink down.
To assess the maximum tolerated doses and overall safety and tolerability of Sunitinib
administered in combination with RAD001 for the treatment of patients with metastatic renal
cell carcinoma.
To assess antitumor activity of the combination of Sunitinib and RAD001.
This study is designed to confirm that the 2 agents can be administered safely in
combination. Patients will begin treatment with Sunitinib and RAD001 on Day 1. RAD001 will
be administered orally on a weekly schedule. Sunitinib will be given orally on a 4 weeks on,
2 weeks off schedule. DLT determination will be based on toxicities observed in Cycle 1 - a
cycle is defined by Sunitinib dosing ( 6 weeks). Once the MTD for the combination has been
identified, a total of 10 patients will be enrolled at the highest dose level that allows
for administration of multiple cycles and provides potentially therapeutic drug levels of
both drugs to further assess safety and tolerability and to obtain a preliminary assessment
of efficacy. Patients will be treated with RAD001 and Sunitinib until there is disease
progression, significant toxicity or withdrawal of patient consent. Patients judged to
derive benefit from treatment would be offered participation in a continuation protocol at
the conclusion of this study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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