Clinical trial NCT00717522: Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: Soft Tissue Sarcoma
CC-4047
Pomalidomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 anticancer therapy.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
timeFrame: AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).
Secondary outcomes:
measure: Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines
timeFrame: Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Coeur d'Alene
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
Study officials:
affiliation: Celgene
name: Abderrahim Fandi, MD
role: STUDY_DIRECTOR
References: