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Tracking Information | |||||
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First Received Date † | November 15, 2006 | ||||
Last Updated Date | January 28, 2009 | ||||
Start Date † | November 2006 | ||||
Current Primary Outcome Measures † |
Overall response rate evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: dependent upon results ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00400569 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma | ||||
Official Title † | Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma | ||||
Brief Summary | This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity. All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study. |
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Detailed Description | This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial PI compromises the ability of the patient to receive treatment or the patient desires to stop treatment. All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study. An office 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, and ECG will be obtained at every scheduled visit. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † |
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Intervention † | Drug: Sunitinib Malate | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 48 | ||||
Estimated Completion Date | August 2010 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00400569 | ||||
Responsible Party | Alberto Chiappori, M.D., H. Lee Moffitt Cancer Center & Research Institute | ||||
Secondary IDs †† | 105022, GA618075 | ||||
Study Sponsor † | H. Lee Moffitt Cancer Center and Research Institute | ||||
Collaborators †† | Pfizer | ||||
Investigators † |
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Information Provided By | H. Lee Moffitt Cancer Center and Research Institute | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |