Back to resultsEfficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
Primary Purpose
Soft Tissue Sarcoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pomalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Soft Tissue Sarcoma, CC-4047, Pomalidomide
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
Sites / Locations
- Sarcoma Oncology Center
- Kootenai Cancer Center
- Nebraska Methodist Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pomalidomide
Arm Description
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
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.
Secondary Outcome Measures
Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines
Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00717522
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Study enrollment was terminated due to a corporate strategic decision unrelated to patient safety.
Study Start Date
August 1, 2008 (Actual)
Primary Completion Date
January 1, 2009 (Actual)
Study Completion Date
January 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
Soft Tissue Sarcoma, CC-4047, Pomalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pomalidomide
Arm Type
Experimental
Arm Description
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
CC-4047, Pomalyst
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
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.
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).
Secondary Outcome Measure Information:
Title
Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines
Description
Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abderrahim Fandi, MD
Organizational Affiliation
Celgene
Official's Role
Study Director
Facility Information:
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Kootenai Cancer Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
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