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Protocol No. UW15058

Principal Investigator Bailey, Howard

Phase II

Age Group Adult

Scope National

Sponsor Type Institutional

Title A Phase II Study of Pazopanib as Front-Line Therapy in Patients with Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy

Objective The purpose of this research study is to look at how people with soft tissue sarcoma respond to treatment with a drug called pazopanib as their first treatment.

Treatment Pazopanib 200 mg orally twice a day for 4 days, then escalated to 400 mg orally twice a day for 4 days, then escalated to 800 mg orally once a day for the duration of the study. Each cycle is 28 days

Description Phase II using Pazopanib in patients with non-resectable or metastatic soft tissue sarcomas who are not candidates for chemotherapy.

Key Eligibility
  • Histologically confirmed diagnosis of nonresectable or metastatic soft tissue sarcoma.
  • Evaluable disease by imaging or physical exam OR measurable disease
  • Not a candidate for chemotherapy
  • ECOG performance status less than or equal to 2
  • Adequate bone marrow and organ function
  • Able to swallow and retain oral pills
  • No prior systemic therapy for this type of sarcoma. Neoadjuvant or adjuvant therapy more than two years prior would not apply.
  • No prior treatment with VEGFR tyrosine kinase inhibitor.
  • No known brain metastases
  • Corrected QTc must be less than 480 msecs
  • Must have controlled hypertension
  • No cerebrovascular accident including transient ischemic attack, pulmonary embolism (PE) (including asymptomatic or previously treated PE), or untreated deep venous thrombosis within the past 6 months. Patients with DVT who are being treated with therapeutic anti-coagulating agents are eligible.
  • No active bleeding or bleeding diathesis.
  • No recent hemoptysis
  • No known HIV-positivity. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

  • Applicable Disease Sites Sarcoma

    Status Open

    Participating Institutions UW Hospital and Clinics