Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00113334|
Recruitment Status : Completed
First Posted : June 8, 2005
Results First Posted : June 12, 2009
Last Update Posted : August 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: ABT-510||Phase 1 Phase 2|
This is a phase Ib/II, single-center, open-label study designed to assess the safety, tolerability, pharmacokinetics, and biologic efficacy of ABT-510 (thrombospondin). Participants will be patients with incurable head and neck cancer.
Patients will begin at a fixed dose level of thrombospondin subcutaneously twice daily. Cycles of treatment are 28 days (4 weeks). Patients will be treated with thrombospondin until progression of tumor or toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer|
|Study Start Date :||April 2005|
|Primary Completion Date :||March 2008|
|Study Completion Date :||March 2008|
Experimental: ABT-510 (Thrombospondin)
Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
100 mg subcutaneously twice daily
Other Name: Thrombospondin Analogue
- Response Rate [ Time Frame: Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years. ]Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon's optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113334
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Edward S. Kim, MD||M.D. Anderson Cancer Center|