Status:
TERMINATED
Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
Lead Sponsor:
Celgene
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 anti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00717522
Start Date
August 1 2008
End Date
January 1 2009
Last Update
November 19 2019
Active Locations (3)
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1
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
2
Kootenai Cancer Center
Coeur d'Alene, Idaho, United States, 83814
3
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114