Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma

A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma

This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.

Inclusion Criteria:

• Histologically or cytologically confirmed soft tissue sarcoma
• Locally advanced, recurrent, or metastatic, unresectable disease
• Measurable disease according to modified RECIST
• ECOG performance status of 0 or 1
• Men or women at least 18 years of age
• Adequate hematological, renal, hepatic, and coagulation function

Exclusion Criteria:

• Prior treatment with anthracyclines
• Uncontrolled cardiovascular disease