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

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Pomalidomide; Thalidomide

Criteria

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