A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma — Rad/Sutent  

Renal Cell Carcinoma Clinical Trial

Official title: A Single Arm, Phase Ib Study of RAD001 and Sunitinib in Patients With Advanced Renal Cell Carcinoma

Status Completed

Clinical Trial Summary

This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at the maximum tolerated dose (MTD) in patients with metastatic RCC . In the dose escalation portion, patients will be treated with sunitinib, given in an intermittent schedule (2 weeks of daily dosing followed by one week off drug. RAD001 will be given daily. Escalation of both drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week cycles, with dose limiting toxicity (DLT) determined by Cycle 2 Day 0.

Clinical Trial Description

Escalation of both drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week cycles, with dose limiting toxicity (DLT) determined by Cycle 2 Day 0. Dose levels will be evaluated one at a time beginning with 3 patients. If 1/3 patients demonstrate DLT (as defined in section Complete), then enrollment will proceed to the next dose level. 1/3 patients develops a DLT, then 3 more patients will be accrued to this dose level. If 0-1/6 patients demonstrate DLT, then enrollment will proceed to the next dose level. However, if 2 or more patients out of 6 demonstrate DLT at a dose level, then enrollment will proceed at the next lowest dose level. The highest dose level not resulting in greater than 1/6 DLT will be considered the MTD. Dose expansion will then proceed at this dose level.

Once the maximum tolerated dose has been established for this regimen a dose expansion of 20 patients with metastatic RCC will be undertaken. Up to 10 patients with a positive FDG- PET scan at baseline (defined by 1 or more target lesions demonstrating an SUV > 5.0) will begin treatment per Figure 2B. Patients 1-10 will begin Sunitinib on Day 0 and begin RAD001 on Day 14 after repeat FDG-PET scan. Patients 11-20, will have a 2 week lead-in period of RAD001 and will begin Sunitinib 2 weeks later on Day 0. After repeat FDG-PET scan. Both groups of patients will repeat PET scan at Day 14 of cycle 2. Patients with negative FDG PET scans (SUV < 5.0 in all lesions) will not undergo repeat scanning. Patients will undergo evaluations for tumor response every 12 weeks with appropriate measurement studies (CT, MRI, bone scan). In the setting of a mixed response (progressive disease in 1 or more lesions but continued regression or stable disease below baseline in other lesions) patients may continue on study if it is determined by the PI, treating physician and patient that there is ongoing clinical benefit to the patient. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

• NCT number: NCT00788060
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 1
• Start date: October 2008
• Completion date: December 2012