Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
Trial ID or NCT#
NCT00717522
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Maria Ahern
6507256413
View on ClinicalTrials.gov
