A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00179751|
Recruitment Status : Terminated
First Posted : September 16, 2005
Last Update Posted : November 7, 2005
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: CC-5013 Drug: gemcitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study Of Lenalidomide (Revlimid ) In Combination With Gemcitabine In Patients With Untreated Advanced Carcinoma Of The Pancreas|
|Study Start Date :||April 2005|
|Estimated Study Completion Date :||August 2006|
- Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide days 1- 21 in combination with gemcitabine days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.
- Phase II-To explore the anti-tumor activity of the combination of lenalidomide on days 1 - 21 and gemcitabine days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.
- Phase I-To explore the anti-tumor activity of the combination of lenalidomide and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
- Phase II-To evaluate the safety profile of the combination of lenalidomide and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
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): NCT00179751
|United States, Louisiana|
|Cancer and Blood Institute|
|Metairie, Louisiana, United States, 70006|
|United States, Missouri|
|Bernard Cancer Center|
|St. Louis, Missouri, United States, 63110|
|United States, Ohio|
|Case Western Reserve University Hospitals Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106|
|United States, South Carolina|
|Charleston Cancer Center|
|Charleston, South Carolina, United States, 29406|
|United States, Tennessee|
|Sarah Cannon Cancer Center|
|Nashville, Tennessee, United States, 37203-1632|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|