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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: | NCT00400569 |
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.
Condition | Intervention | Phase |
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Liposarcoma Leiomyosarcoma Fibrosarcoma |
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 (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma |
Estimated Enrollment: | 48 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Sunitinib Malate
For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed bya 2 week rest period.
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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.
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:
Any of the following within the 6 months prior to study drug administration:
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Alberto Chiappori, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute ( Alberto Chiappori, M.D. ) |
Study ID Numbers: | MCC-14902, 105022, GA618075 |
Study First Received: | November 15, 2006 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00400569 History of Changes |
Health Authority: | United States: Institutional Review Board |
Sunitinib malate SUTENT SU011248 Soft tissue sarcoma Gastrointestinal stromal tumors (GIST) |
Tyrosine kinase inhibitor Imatinib mesylate Phase II Malignant Fibrous Histiocytoma (MFH) |
Histiocytoma, Malignant Fibrous Fibrosarcoma Leiomyosarcoma Histiocytoma, Benign Fibrous Tyrosine Angiogenesis Inhibitors Imatinib Malignant Fibrous Histiocytoma |
Neoplasms, Connective and Soft Tissue Liposarcoma Malignant Mesenchymal Tumor Soft Tissue Sarcomas Histiocytoma Sunitinib Sarcoma Gastrointestinal Stromal Tumors |
Fibrosarcoma Neoplasms, Muscle Tissue Neoplasms by Histologic Type Leiomyosarcoma Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions Neoplasms, Connective and Soft Tissue |
Liposarcoma Neoplasms Sunitinib Therapeutic Uses Sarcoma Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Neoplasms, Adipose Tissue |