Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Celgene Corporation

Stanford Investigator(s):

Intervention(s):

  • Drug: Pomalidomide

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Ahern
6507256413
Not Recruiting