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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00717522
Recruitment Status : Terminated (Study enrollment was terminated due to a corporate strategic decision unrelated to patient safety.)
First Posted : July 17, 2008
Results First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Soft Tissue Sarcoma
Intervention Drug: Pomalidomide
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pomalidomide
Hide Arm/Group Description 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
Period Title: Overall Study
Started 7
Completed 0
Not Completed 7
Reason Not Completed
Disease Progression             5
Adverse Event             1
Death             1
Arm/Group Title Pomalidomide
Hide Arm/Group Description 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
58.9  (13.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
3
  42.9%
Male
4
  57.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants
White 7
Non-white 0
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Pomalidomide
Hide Arm/Group Description:
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
≥1 AE 7
≥1 AE suspected to be related to study drug 6
≥1 Grade 3 AE 4
≥1 Grade 4 AE 1
≥1 SAE 3
≥1 SAE suspected to be related to study drug 1
Death 4
Death within 30 days of last dose of study drug 1
Discontinuation due to AE 2
Dose reduction and interruption due to AE 1
2.Secondary Outcome
Title Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines
Hide 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).
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not done. Study enrollment was suspended due to a corporate strategic decision unrelated to patient safety, and the protocol was amended to evaluate safety only (efficacy data was stored but not cleaned or analyzed unless related to safety).
Arm/Group Title Pomalidomide
Hide Arm/Group Description:
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. Median treatment duration was 49 days (range: 3 to 102 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pomalidomide
Hide Arm/Group Description 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
All-Cause Mortality
Pomalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pomalidomide
Affected / at Risk (%)
Total   3/7 (42.86%) 
Blood and lymphatic system disorders   
Anaemia  1  1/7 (14.29%) 
Febrile Neutropenia  1  1/7 (14.29%) 
Leukopenia  1  1/7 (14.29%) 
Neutropenia  1  1/7 (14.29%) 
Cardiac disorders   
Tachycardia  1  1/7 (14.29%) 
Gastrointestinal disorders   
Dysphagia  1  1/7 (14.29%) 
Metabolism and nutrition disorders   
Malnutrition  1  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders   
Muscle Spasms  1  1/7 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer Pain  1  2/7 (28.57%) 
Sarcoma Metastatic  1  1/7 (14.29%) 
Nervous system disorders   
Syncope  1  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/7 (14.29%) 
Pleural Effusion  1  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pomalidomide
Affected / at Risk (%)
Total   7/7 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  3/7 (42.86%) 
Neutropenia  1  3/7 (42.86%) 
Thrombocytopenia  1  2/7 (28.57%) 
Gastrointestinal disorders   
Nausea  1  3/7 (42.86%) 
Constipation  1  2/7 (28.57%) 
Dry mouth  1  2/7 (28.57%) 
Abdominal pain  1  1/7 (14.29%) 
Ascites  1  1/7 (14.29%) 
Dysphagia  1  1/7 (14.29%) 
Palatal disorder  1  1/7 (14.29%) 
Tongue disorder  1  1/7 (14.29%) 
Vomiting  1  1/7 (14.29%) 
General disorders   
Fatigue  1  2/7 (28.57%) 
Asthenia  1  1/7 (14.29%) 
Chills  1  1/7 (14.29%) 
Malaise  1  1/7 (14.29%) 
Oedema peripheral  1  1/7 (14.29%) 
Pain  1  1/7 (14.29%) 
Pyrexia  1  1/7 (14.29%) 
Immune system disorders   
Hypersensitivity  1  1/7 (14.29%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  1/7 (14.29%) 
Investigations   
Alanine aminotransferase increased  1  1/7 (14.29%) 
Ammonia increased  1  1/7 (14.29%) 
Aspartate aminotransferase increased  1  1/7 (14.29%) 
Blood creatinine increased  1  1/7 (14.29%) 
Blood lactate dehydrogenase increased  1  1/7 (14.29%) 
Electrocardiogram q waves  1  1/7 (14.29%) 
International normalised ratio increased  1  1/7 (14.29%) 
Weight decreased  1  1/7 (14.29%) 
Metabolism and nutrition disorders   
Hypoalbuminaemia  1  2/7 (28.57%) 
Hypocalcaemia  1  2/7 (28.57%) 
Hypokalaemia  1  2/7 (28.57%) 
Cachexia  1  1/7 (14.29%) 
Dehydration  1  1/7 (14.29%) 
Hyperglycaemia  1  1/7 (14.29%) 
Hypomagnesaemia  1  1/7 (14.29%) 
Hypophagia  1  1/7 (14.29%) 
Iron deficiency  1  1/7 (14.29%) 
Malnutrition  1  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders   
Joint stiffness  1  1/7 (14.29%) 
Musculoskeletal pain  1  1/7 (14.29%) 
Pain in extremity  1  1/7 (14.29%) 
Nervous system disorders   
Dizziness  1  1/7 (14.29%) 
Lethargy  1  1/7 (14.29%) 
Tremor  1  1/7 (14.29%) 
Vocal cord paralysis  1  1/7 (14.29%) 
Psychiatric disorders   
Anxiety  1  1/7 (14.29%) 
Libido decreased  1  1/7 (14.29%) 
Personality change  1  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  2/7 (28.57%) 
Cough  1  1/7 (14.29%) 
Dysphonia  1  1/7 (14.29%) 
Haemoptysis  1  1/7 (14.29%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  1/7 (14.29%) 
Dermatitis allergic  1  1/7 (14.29%) 
Ecchymosis  1  1/7 (14.29%) 
Erythema  1  1/7 (14.29%) 
Exfoliative rash  1  1/7 (14.29%) 
Rash  1  1/7 (14.29%) 
Vascular disorders   
Deep vein thrombosis  1  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene’s request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation.
Results Point of Contact
Name/Title: Associate Director, Clinical Trial Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT00717522     History of Changes
Other Study ID Numbers: CC-4047-STSAR-001
First Submitted: July 16, 2008
First Posted: July 17, 2008
Results First Submitted: March 6, 2013
Results First Posted: April 16, 2013
Last Update Posted: April 16, 2013