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
18 Years
N/A
Both
Soft Tissue Sarcoma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
Outcome Description:
An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject's health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.
Outcome Time Frame:
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).
Safety Issue:
Yes
Principal Investigator
Abderrahim Fandi, MD
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
United States: Food and Drug Administration
Study ID:
CC-4047-STSAR-001
NCT ID:
NCT00717522
Start Date:
August 2008
Completion Date:
January 2009
Related Keywords:
- Soft Tissue Sarcoma
- Soft Tissue Sarcoma
- CC-4047
- Pomalidomide
- Sarcoma
Name | Location |
|---|---|
| Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
| Kootenai Cancer Center | Post Falls, Idaho 83854 |
| Sarcoma Oncology Center | Santa Monica, California 90403 |
