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

Celgene

Status and phase: Terminated; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Drug: Pomalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717522

CC-4047-STSAR-001

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Pomalidomide

Experimental group

Description:

7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle

Treatment:

Drug: Pomalidomide