A Phase II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma
- Estimate the proportion of patients with previously treated metastatic or unresectable
clear cell carcinoma of the kidney who are progression free (complete response [CR],
partial response [PR], or stable disease [SD]) at 3 months after treatment with
everolimus and imatinib mesylate.
- Estimate median time to progression in patients treated with this regimen.
- Determine the proportion of patients whose best overall response are CR, PR, SD, or
- Evaluate the mean and range of the maximum percent reduction in tumor size.
- Describe the toxicities of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1
and continuing in the absence of disease progression.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival at 3 Months
3 months post 1st dose
Christopher W. Ryan, MD
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|