Study of Everolimus (RAD001) in Combination With Lenalidomide
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|ClinicalTrials.gov Identifier: NCT01218555|
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Organ Malignancies Adenoidcystic Carcinoma Neuroendocrine Tumors||Drug: Lenalidomide Drug: Everolimus||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Everolimus (RAD001) in Combination With Lenalidomide in Patients With Advanced Solid Malignancies Enriched for Renal Cell Carcinoma|
|Actual Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Experimental: Lenalidomide combination with everolimus
Non-randomized study of escalating doses of daily, orally administered lenalidomide in combination with standard doses of everolimus, an orally available mammalian target of rapamycin (mTOR) inhibitor.
Lenalidomide (10mg, 15mg, 20mg or 25mg) once daily by mouth, every day of each 28-day cycle.
Other Name: Revlimid
5mg or 10mg of everolimus administered once daily by mouth on a once daily continuous dosing schedule for 28 days.
- 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. ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218555
|United States, Georgia|
|Grady Health System|
|Atlanta, Georgia, United States, 30303|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Taofeek Owonikoko, PhD/MD||Emory University Winship Cancer Institute|