Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006719-21 | EudraCT Number | ||
| CP13-0707 | Other Identifier | ImClone, LLC | |
| I5A-IE-JAEC | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants will be stratified into five tiers according to diagnosis:
A total of 85 participants will be enrolled initially, 17 in each tier. Participants will receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.
The purpose of this study is to determine the progression-free survival (PFS) rate assessed 12 weeks after the initiation of IMC-A12 monotherapy, administered every 2 weeks to participants with previously-treated, advanced or metastatic soft tissue and Ewing's sarcoma/PNET.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-A12 (cixutumumab) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-A12 (cixutumumab) | Biological | Ewing's Sarcoma/PNET 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | PFS at 12 weeks was reported by disease condition and defined as the percentage of participants who have neither experienced disease progression nor died at 12 weeks after the date of first dose. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 12 weeks divided by the total number of participants treated then multiplied by 100. | Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was reported by disease condition and defined as the interval from the date of first dose until disease progression or death whichever occurred earlier. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience disease progression or death. |
Not provided
Inclusion:
Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| E-mail: ClinicalTrials@ ImClone.com | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Aurora | Colorado | 80045 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22682017 | Derived | Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7. |
Not provided
Not provided
Presented are the reasons the participants discontinued from study treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Entire Study Population | IMC-A12 (cixutumumab) 10 milligrams per kilogram (mg/kg) dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Participants were stratified into 5 arms according to the disease condition: Ewing's Sarcoma/peripheral neuroectodermal tumor (PNET), rhabdomyosarcoma, leiomyosarcoma, adipocytic sarcoma, and synovial sarcoma. Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| IMC-A12 (cixutumumab) | Biological | Rhabdomyosarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
|
|
| IMC-A12 (cixutumumab) | Biological | Leiomyosarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
|
|
| IMC-A12 (cixutumumab) | Biological | Adipocytic sarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
|
|
| IMC-A12 (cixutumumab) | Biological | Synovial sarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
|
|
| Baseline to measured PD (up to 105.4 weeks) |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | ORR was reported by disease condition and defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100. | Baseline to measured PD (up to 105.4 weeks) |
| Time to Response | Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks) |
| Duration of Response | Date of first response to the date of progression or death due to any cause (up to 105.4 weeks) |
| Overall Survival (OS) | OS was reported by disease condition and defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. | Baseline to date of death from any cause (up to 112.9 weeks) |
| Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)] | CBR was reported by disease condition. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria. Percentage of participants with best overall response is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100. | Baseline through study completion (up to 105.4 weeks) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths | TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs, serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Event module. | Baseline through study completion (up to 112.9 weeks) |
| Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity) | 30-day safety follow-up |
| Orlando |
| Florida |
| 32806 |
| United States |
| ImClone Investigational Site | Metairie | Louisiana | 70006-2921 | United States |
| ImClone Investigational Site | Metairie | Louisiana | 70006 | United States |
| ImClone Investigational Site | Detroit | Michigan | 48201-2014 | United States |
| ImClone Investigational Site | St Louis | Missouri | 63110 | United States |
| ImClone Investigational Site | Columbus | Ohio | 43210 | United States |
| ImClone Investigational Site | Brussels | 1000 | Belgium |
| ImClone Investigational Site | Leuven | 3000 | Belgium |
| ImClone Investigational Site | Wilrijk | 2610 | Belgium |
| ImClone Investigational Site | Bordeaux | 33076 | France |
| ImClone Investigational Site | Lyon | 69008 | France |
| ImClone Investigational Site | Paris | 75231 | France |
| ImClone Investigational Site | Toulouse | 31052 | France |
| ImClone Investigational Site | Dresden | 01307 | Germany |
| ImClone Investigational Site | Mannheim | 68167 | Germany |
| ImClone Investigational Site | Leiden | 2333 ZA | Netherlands |
| ImClone Investigational Site | Warsaw | 02-781 | Poland |
| ImClone Investigational Site | Barcelona | 08025 | Spain |
| ImClone Investigational Site | Barcelona | 08035 | Spain |
| ImClone Investigational Site | Barcelona | 08041 | Spain |
| ImClone Investigational Site | Barcelona | 08907 | Spain |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Participants were stratified into 5 arms according to the disease condition: Ewing's Sarcoma/PNET, rhabdomyosarcoma, leiomyosarcoma, adipocytic sarcoma, and synovial sarcoma. Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | PFS at 12 weeks was reported by disease condition and defined as the percentage of participants who have neither experienced disease progression nor died at 12 weeks after the date of first dose. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 12 weeks divided by the total number of participants treated then multiplied by 100. | Enrolled participants who received any quantity of IMC-A12. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was reported by disease condition and defined as the interval from the date of first dose until disease progression or death whichever occurred earlier. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience disease progression or death. | Enrolled participants who received any quantity of IMC-A12. Three (3) participants in Ewing's sarcoma/PNET, 1 participant in rhabdomyosarcoma, 4 participants in leiomyosarcoma, 6 participants in adipocytic sarcoma, and 3 participants in synovial sarcoma groups were censored for analysis. | Posted | Median | 95% Confidence Interval | weeks | Baseline to measured PD (up to 105.4 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | ORR was reported by disease condition and defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100. | Enrolled participants who received any quantity of IMC-A12. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to measured PD (up to 105.4 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Zero participants analyzed. Time to Response for CR and PR data was not collected for analysis per study report. | Posted | Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Zero participants analyzed. Duration to Response for CR and PR data was not collected for analysis per study report. | Posted | Date of first response to the date of progression or death due to any cause (up to 105.4 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was reported by disease condition and defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. | Enrolled participants who received any quantity of IMC-A12. Five (5) participants in Ewing's sarcoma/PNET, 4 participants in rhabdomyosarcoma, 12 participants in leiomyosarcoma, 11 participants in adipocytic sarcoma, and 5 participants in synovial sarcoma groups were censored for analysis. | Posted | Median | 95% Confidence Interval | weeks | Baseline to date of death from any cause (up to 112.9 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)] | CBR was reported by disease condition. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria. Percentage of participants with best overall response is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100. | Enrolled participants who received any quantity of IMC-A12. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through study completion (up to 105.4 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths | TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs, serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Event module. | Enrolled participants who received any quantity of IMC-A12. | Posted | Count of Participants | Participants | No | Baseline through study completion (up to 112.9 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity) | Zero participants analyzed. Analysis was not performed due to lack of available assay. | Posted | 30-day safety follow-up |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entire Study Population | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Participants were stratified into 5 arms according to the disease condition: Ewing's sarcoma/PNET, rhabdomyosarcoma, leiomyosarcoma, adipocytic sarcoma, and synovial sarcoma. Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. | 56 | 111 | 97 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chorioretinopathy | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D012208 | Rhabdomyosarcoma |
| D007890 | Leiomyosarcoma |
| D013584 | Sarcoma, Synovial |
| D012509 | Sarcoma |
| D012512 | Sarcoma, Ewing |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| ID | Term |
|---|---|
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009372 | Neoplasms, Connective Tissue |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C557414 | cixutumumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Other |
|
| Poland |
|
| Spain |
|
| Belgium |
|
| Germany |
|
| Netherlands |
|
| OG002 | Leiomyosarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent. |
| OG003 | Adipocytic Sarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent. |
| OG004 | Synovial Sarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent. |
| OG005 | Total | Total of all reporting groups. |
|
|
| Leiomyosarcoma |
IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent. |
| OG003 | Adipocytic Sarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent. |
| OG004 | Synovial Sarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawn consent. |
| OG005 | Total | Total of all reporting groups. |
|
|
IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. |
| OG003 | Adipocytic Sarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. |
| OG004 | Synovial Sarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. |
| OG005 | Total | Total of all reporting groups. |
|
|
| OG002 |
| Leiomyosarcoma |
IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. |
| OG003 | Adipocytic Sarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. |
| OG004 | Synovial Sarcoma | IMC-A12 (cixutumumab) 10 mg/kg dose administered as intravenous infusion over a period of 1 hour once every 2 weeks (6-week cycle). Treatment was continued until there was evidence of disease progression, unacceptable toxicity, or withdrawal of consent. |
| OG005 | Total | Total of all reporting groups. |
|
|
|