Clinical Trial: Study of Everolimus (RAD001) in Combination With Lenalidomide

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase I Study of Everolimus (RAD001) in Combination With Lenalidomide in Patients With Advanced Solid Malignancies Enriched for Renal Cell Carcinoma

Brief Summary: The purpose of this study is to study the combination of two anticancer drugs, everolimus (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard treatment or patients who are unable to tolerate the standard treatment for their cancer.

Detailed Summary:

The purpose of this study is to study the combination of two anticancer drugs, everolimus (RAD001) and lenalidomide in patients whose cancer is no longer responding to standard treatment or patients who are unable to tolerate the standard treatment for their cancer. The investigators seek to establish the safety of taking these two medications together and to determine the appropriate doses of the two drugs when given together as well as identify potential side effects when the drugs are administered together.

Another purpose of this study is to find out if the medication works for the patient's kind of cancer and side effects of the combination of RAD001 and lenalidomide by looking at the patient's response to the treatment. The investigators want to find out what effects, good or bad, the drugs have on the patient's cancer.

This study will also look at specific substances called biomarkers in the patient's blood and in the tumor tissue which are involved in the growth of tumor cells and determine if the levels of these biomarkers are related to the patient's response to treatment or development of side effects.

An expansion cohort is currently enrolling patients with adenoidcystic carcinoma, neuroendocrine and kidney cancer.

Sponsor: Emory University

Current Primary Outcome: The maximum doses of both drugs that can be administered without inducing dose limiting toxicity (DLT) in ≥ 33% of the treated patient cohort [ Time Frame: Within the first 28 days for DLT and throughout the duration of the study for safety. ]

Original Primary Outcome: The maximum doses of both drugs that can be administered without inducing dose limiting toxicity (DLT) in ≥33% of the treated patient cohort. [ Time Frame: Within the first 28 days for DLT and throughout the duration of the study for safety. ]

Current Secondary Outcome: The frequency of achieving a complete plus partial response with the 2 drug combination by dose cohort to be assessed by non-investigational cross sectional imaging after every 2 cycles [ Time Frame: After every 2 cycles (every 8 weeks) ]

Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: October 8, 2010
Date Started: September 2010
Date Completion: March 2018
Last Updated: March 1, 2017
Last Verified: March 2017