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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Pfizer |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00495625 |
An open label multi-site phase II clinical trial of dose escalated sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.
Condition | Intervention | Phase |
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Liver |
Drug: Sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Open-Label Study of Sunitinib Malate (SUO11248) in Adult Subjects With Metastatic and/or Surgically Unresectable Hepatocellular Cancers |
Estimated Enrollment: | 42 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
SU011248 Treatment
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Drug: Sunitinib malate
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5mg daily for 28 days, every 42 days. Dose may be escalated to 50mg daily for 28 days at the treating investigator's discretion.
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An open label multi-site phase II clinical trial of sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Sunitinib malate will be dispensed as capsules at the beginning of each treatment cycle.The dose may be escalated at the investigator's discretion. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.
A follow up visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count and differential, comprehensive metabolic panel (including liver function tests) and alpha-feto protein (when indicated) will be obtained at every scheduled follow up visit.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function as defined by the following criteria:
Exclusion Criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Chris Garrett, MD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute, Inc. ( Jonathan Strosberg ) |
Study ID Numbers: | MCC-14733, Pfizer #2005-0880 |
Study First Received: | June 29, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00495625 |
Health Authority: | United States: Institutional Review Board |
Hepatocellular cancer (HCC) Sunitinib malate Vascular endothelial growth factor (VEGF) Platelet-derived growth factor (PDGF) Tyrosine kinases |
Sunitinib Endothelial Growth Factors Hepatocellular carcinoma |
Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |