A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
|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: NCT01263899|
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : April 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma Mantle Cell Lymphoma Indolent Lymphoma||Drug: SB1518||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.
- Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ]Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
- Assess durability of response [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ]To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies.
- Assess number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ]To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.
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): NCT01263899
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, New York|
|Weill Medical College of Cornell|
|New York, New York, United States, 10021|
|University of Rochester James P. Wilmot Cancer Center|
|Rochester, New York, United States, 14642|
|United States, Texas|
|MD Anderson Cancer Canter|
|Houston, Texas, United States, 77030|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||Anas Younes, MD||MD Anderson Cancer Center at University of Texas, Houston|
|Principal Investigator:||Jonathan Friedberg, MD||University of Rochester James P. Wilmot Cancer Center|
|Principal Investigator:||Peter Martin, MD||Weill Medical College of Cornell University|
|Principal Investigator:||Julie Vose, MD||University of Nebraska|
|Principal Investigator:||Richard Klasa, MD||British Columbia Cancer Center - Vancouver Centre|