Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT01348503|
Recruitment Status : Terminated (Treatment was ineffective)
First Posted : May 5, 2011
Last Update Posted : August 31, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Lenalidomide Drug: Sorafenib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Open-label Dose-escalation Study With Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2014|
Experimental: Open Label, Single Arm
Dose escalation of lenalidomide in combination with sorafenib at standard doses in patients with advanced, unresectable hepatocellular carcinoma.
Escalating doses starting at 15 mg by mouth per day.
Fixed dose of 400 mg by mouth twice a day.
- Number of Participants with Dose Limiting Toxicities as a Measure of Safety of the combination of lenalidomide and sorafenib. [ Time Frame: 2 years ]
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): NCT01348503
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||E. Gabriela Chiorean, MD||Indiana University Melvin and Bren Simon Cancer Center|