NCT00331409

Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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 progressive disease. * 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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	2.5 mg by mouth daily
DRUG	imatinib mesylate	600 mg by mouth daily

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2006-05-31
• Last updated: 2017-10-26
• Results posted: 2011-10-05

Locations

1 site across 1 country: United States