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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Pfizer |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00330564 |
Primary objectives:
Secondary objectives:
Correlative objectives:
Condition | Intervention | Phase |
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Von Hippel-Lindau Syndrome |
Drug: SU011248 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study of SU011248 (Sunitinib Malate) in Von Hippel-Lindau Syndrome |
Estimated Enrollment: | 28 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
SU011248
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Drug: SU011248
50 mg/day orally for 4 weeks, no treatment for 2 weeks (6 weeks = 1 cycle).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cherie A Perez, BS, RN | 713-563-1602 | |
Contact: Eric Jonasch, MD | 713-792-2830 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Cherie A Perez, BS RN 713-563-1602 | |
Contact: Surena Matin, M.D., FACS 713-792-3250 | |
Sub-Investigator: Surena F Matin, M.D., FACS | |
Principal Investigator: Eric Jonasch, MD |
Principal Investigator: | Eric Jonasch, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Eric Jonasch, MD/Asst. Professor ) |
Study ID Numbers: | 2005-0463 |
Study First Received: | May 26, 2006 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00330564 |
Health Authority: | United States: Food and Drug Administration |
VHL Syndrome Von Hippel-Lindau Syndrome Sunitinib Malate SU011248 VHL Disease |
Angiomatosis Von Hippel-Lindau Disease Sunitinib |
Von Hippel-Lindau syndrome Vascular Diseases Neurocutaneous Syndromes |
Disease Antineoplastic Agents Growth Substances Nervous System Diseases Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions |
Pathologic Processes Syndrome Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Growth Inhibitors |