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Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
Not Recruiting
Trial ID: NCT00717522
Purpose
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
Professor of Medicine (Oncology)
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
Intervention(s):
drug: Pomalidomide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maria Ahern
6507256413