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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Abbott |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00113334 |
The goals of this clinical research study are to see how individuals with advanced head and neck cancer respond to treatment with the new drug thrombospondin (ABT-510) and to learn how effective it is in destroying cancer cells. The safety of ABT-510 and the effect ABT-510 has on cells in the body will also be studied.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: ABT-510 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer |
Enrollment: | 6 |
Study Start Date: | April 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ABT-510 (Thrombospondin): Experimental |
Drug: ABT-510
100 mg subcutaneously twice daily
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | University of Texas M.D. Anderson Cancer Center ( Edward S. Kim, M.D./Assistant Professor ) |
Study ID Numbers: | 2003-1027 |
Study First Received: | June 7, 2005 |
Results First Received: | April 24, 2009 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00113334 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Head and Neck Cancer Thrombospondin Analogue ABT-510 Antiangiogenic agent |
Lung Skin Thyroid |
Head and Neck Neoplasms Angiogenesis Inhibitors |
Neoplasms Neoplasms by Site Head and Neck Neoplasms |