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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-01

Study Completion Date

2009-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Soft Tissue Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pomalidomide

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

Group Type EXPERIMENTAL

Pomalidomide

Intervention Type DRUG

Interventions

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Pomalidomide

Intervention Type DRUG

Other Intervention Names

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CC-4047 Pomalyst

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No