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

Not Recruiting

Trial ID: NCT00717522


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.

Official Title

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

Stanford Investigator(s)

Kristen N Ganjoo
Kristen N Ganjoo

Professor of Medicine (Oncology)


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

   - 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


drug: Pomalidomide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Ahern

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