Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
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 Principal Investigator (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
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 (CBC) and differential,
comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Response (OR)
Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
From On Treatment to Off Study - average of 6 months
Alberto Chiappori, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|