Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma

A Phase 2, Multicenter, Open-label, Single Arm, Two-stage Study to Evaluate the Efficacy and Safety of CC-4047 (Pomalidomide) in Patients With Advanced Soft Tissue Sarcomas Who Have Relapsed or Are Refractory to Systemic Anticancer Therapy

The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.

Inclusion Criteria:

• Must be > 18 years of age
• Must have histologically confirmed soft tissue sarcoma
• Must have locally recurrent unresectable, or metastatic soft tissue sarcoma, and have failed or relapsed after a minimum of one and a maximum of 3 prior systemic anticancer therapy regimens
• Must have measurable or evaluable disease determined as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Must have documented disease progression (PD) determined as per RECIST criteria within 3 months prior to study enrollment
• Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

• Pregnant or lactating females
• Prior therapy with thalidomide or lenalidomide
• Prior use of experimental/investigational drug therapy < 3 months prior to treatment initiation
• Prior chemotherapy, biologic or immunotherapy < 3 weeks prior to treatment initiation
• Prior radiotherapy < 3 weeks prior to treatment initiation
• Prior major surgery < 3 weeks prior to treatment initiation
• Absolute neutrophil count (ANC) < 1.5 x 109 cells/L
• Platelet count < 100 x 109cells/L
• Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvate transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN) or > 5.0 x ULN in the presence of demonstrable liver metastases
• Known active central nervous system (CNS) metastases