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Study enrollment was terminated due to a corporate strategic decision unrelated to patient safety.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomalidomide | Experimental | 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abderrahim Fandi, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States | ||
| Kootenai Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pomalidomide | 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pomalidomide | 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants | Posted | Number | participants | 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). |
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pomalidomide | 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trial Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
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| 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). |
| Coeur d'Alene |
| Idaho |
| 83814 |
| United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Pomalidomide | 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle |
|
|
| Secondary | 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. | 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). | Posted | 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). |
|
|
| 3 |
| 7 |
| 7 |
| 7 |
| Sarcoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Palatal disorder | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Ammonia increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Electrocardiogram q waves | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
|
| Personality change | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
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.