NCT00422344

A Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma

A Phase I Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Cell Carcinoma
• Kidney Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-01-15
• Last updated: 2010-02-26

Locations

1 site across 1 country: United States