Trial Outcomes & Findings for A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma (NCT NCT00668148)
NCT ID: NCT00668148
Last Updated: 2018-07-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks
Results posted on
2018-07-17
Participant Flow
Presented are the reasons the participants discontinued from study treatment.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
113
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
111
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Subject Non-compliance
|
1
|
|
Overall Study
Progressive Disease Before Treatment
|
2
|
|
Overall Study
Withdrawal of Consent
|
2
|
Baseline Characteristics
A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=111 Participants
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.
|
|---|---|
|
Age, Continuous
|
47.0 years
FULL_RANGE 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Disease Progression or Death Due to Any Cause Up To 12 WeeksPopulation: Enrolled participants who received any quantity of IMC-A12.
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.
Outcome measures
| Measure |
Ewing's Sarcoma/PNET
n=18 Participants
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.
|
Rhabdomyosarcoma
n=17 Participants
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.
|
Leiomyosarcoma
n=22 Participants
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.
|
Adipocytic Sarcoma
n=37 Participants
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.
|
Synovial Sarcoma
n=17 Participants
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.
|
Total
n=111 Participants
Total of all reporting groups.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks
|
27.3 percentage of participants
Interval 8.5 to 50.4
|
12.5 percentage of participants
Interval 2.1 to 32.8
|
25.4 percentage of participants
Interval 8.4 to 46.8
|
50.0 percentage of participants
Interval 32.9 to 64.9
|
21.4 percentage of participants
Interval 5.2 to 44.8
|
31.9 percentage of participants
Interval 23.0 to 41.1
|
SECONDARY outcome
Timeframe: Baseline to measured PD (up to 105.4 weeks)Population: 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.
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.
Outcome measures
| Measure |
Ewing's Sarcoma/PNET
n=18 Participants
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.
|
Rhabdomyosarcoma
n=17 Participants
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.
|
Leiomyosarcoma
n=22 Participants
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.
|
Adipocytic Sarcoma
n=37 Participants
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.
|
Synovial Sarcoma
n=17 Participants
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.
|
Total
n=111 Participants
Total of all reporting groups.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
6.4 weeks
Interval 5.1 to 12.1
|
6.1 weeks
Interval 5.1 to 7.3
|
6.0 weeks
Interval 5.4 to 11.0
|
12.1 weeks
Interval 6.0 to 17.7
|
6.4 weeks
Interval 5.6 to 11.9
|
6.7 weeks
Interval 6.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline to measured PD (up to 105.4 weeks)Population: Enrolled participants who received any quantity of IMC-A12.
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.
Outcome measures
| Measure |
Ewing's Sarcoma/PNET
n=18 Participants
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.
|
Rhabdomyosarcoma
n=17 Participants
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.
|
Leiomyosarcoma
n=22 Participants
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.
|
Adipocytic Sarcoma
n=37 Participants
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.
|
Synovial Sarcoma
n=17 Participants
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.
|
Total
n=111 Participants
Total of all reporting groups.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
|
5.6 percentage of participants
Interval 0.1 to 27.3
|
0 percentage of participants
Interval 0.0 to 19.5
|
0 percentage of participants
Interval 0.0 to 15.4
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
0 percentage of participants
Interval 0.0 to 19.5
|
1.8 percentage of participants
Interval 0.2 to 6.4
|
SECONDARY outcome
Timeframe: Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks)Population: Zero participants analyzed. Time to Response for CR and PR data was not collected for analysis per study report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date of first response to the date of progression or death due to any cause (up to 105.4 weeks)Population: Zero participants analyzed. Duration to Response for CR and PR data was not collected for analysis per study report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to date of death from any cause (up to 112.9 weeks)Population: 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.
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.
Outcome measures
| Measure |
Ewing's Sarcoma/PNET
n=18 Participants
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.
|
Rhabdomyosarcoma
n=17 Participants
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.
|
Leiomyosarcoma
n=22 Participants
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.
|
Adipocytic Sarcoma
n=37 Participants
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.
|
Synovial Sarcoma
n=17 Participants
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.
|
Total
n=111 Participants
Total of all reporting groups.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
24.1 weeks
Interval 12.6 to 37.6
|
23.6 weeks
Interval 8.9 to 52.1
|
NA weeks
Interval 25.7 to
Median OS and upper limit of 95% confidence interval could not be mathematically calculated due to high censoring rate.
|
46.4 weeks
Interval 31.3 to 61.1
|
56.3 weeks
Interval 22.3 to 71.3
|
38.4 weeks
Interval 31.1 to 52.0
|
SECONDARY outcome
Timeframe: Baseline through study completion (up to 105.4 weeks)Population: Enrolled participants who received any quantity of IMC-A12.
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.
Outcome measures
| Measure |
Ewing's Sarcoma/PNET
n=18 Participants
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.
|
Rhabdomyosarcoma
n=17 Participants
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.
|
Leiomyosarcoma
n=22 Participants
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.
|
Adipocytic Sarcoma
n=37 Participants
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.
|
Synovial Sarcoma
n=17 Participants
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.
|
Total
n=111 Participants
Total of all reporting groups.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)]
|
33.3 percentage of participants
Interval 13.3 to 59.0
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
40.9 percentage of participants
Interval 20.7 to 63.6
|
56.8 percentage of participants
Interval 39.5 to 72.9
|
35.3 percentage of participants
Interval 14.2 to 61.7
|
41.4 percentage of participants
Interval 32.2 to 51.2
|
SECONDARY outcome
Timeframe: Baseline through study completion (up to 112.9 weeks)Population: Enrolled participants who received any quantity of IMC-A12.
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.
Outcome measures
| Measure |
Ewing's Sarcoma/PNET
n=111 Participants
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.
|
Rhabdomyosarcoma
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.
|
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.
|
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.
|
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.
|
Total
Total of all reporting groups.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
Death Due to Other Cause
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
Any TEAE
|
108 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
Serious TEAE
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
Deaths Due to Disease Progression
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
Death Due to AE
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30-day safety follow-upPopulation: Zero participants analyzed. Analysis was not performed due to lack of available assay.
Outcome measures
Outcome data not reported
Adverse Events
Entire Study Population
Serious events: 56 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Study Population
n=111 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
2/111 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.90%
1/111 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.90%
1/111 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.90%
1/111 • Number of events 2
|
|
Eye disorders
Chorioretinopathy
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Malabsorption
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Subileus
|
0.90%
1/111 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Asthenia
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Chest pain
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Disease progression
|
12.6%
14/111 • Number of events 16
|
|
General disorders
General physical health deterioration
|
1.8%
2/111 • Number of events 2
|
|
General disorders
Infusion related reaction
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.90%
1/111 • Number of events 1
|
|
General disorders
Pain
|
5.4%
6/111 • Number of events 7
|
|
Infections and infestations
Catheter related infection
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Endocarditis bacterial
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Infection
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.7%
3/111 • Number of events 3
|
|
Infections and infestations
Pyelonephritis
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Tracheobronchitis
|
0.90%
1/111 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.90%
1/111 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.8%
2/111 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.8%
2/111 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.90%
1/111 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.90%
1/111 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.90%
1/111 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.90%
1/111 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.90%
1/111 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.90%
1/111 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.7%
3/111 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Spinal cord compression
|
0.90%
1/111 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.90%
1/111 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.90%
1/111 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
2.7%
3/111 • Number of events 3
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
4/111 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.6%
4/111 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.8%
2/111 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.90%
1/111 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
0.90%
1/111 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.90%
1/111 • Number of events 1
|
Other adverse events
| Measure |
Entire Study Population
n=111 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.7%
13/111 • Number of events 29
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
6/111 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain
|
9.0%
10/111 • Number of events 24
|
|
Gastrointestinal disorders
Constipation
|
14.4%
16/111 • Number of events 18
|
|
Gastrointestinal disorders
Diarrhoea
|
22.5%
25/111 • Number of events 42
|
|
Gastrointestinal disorders
Nausea
|
25.2%
28/111 • Number of events 32
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
15/111 • Number of events 18
|
|
General disorders
Asthenia
|
15.3%
17/111 • Number of events 81
|
|
General disorders
Chest pain
|
5.4%
6/111 • Number of events 6
|
|
General disorders
Fatigue
|
23.4%
26/111 • Number of events 36
|
|
General disorders
Mucosal inflammation
|
5.4%
6/111 • Number of events 7
|
|
General disorders
Oedema peripheral
|
6.3%
7/111 • Number of events 8
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.4%
6/111 • Number of events 7
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
6/111 • Number of events 8
|
|
Investigations
Blood creatinine increased
|
11.7%
13/111 • Number of events 22
|
|
Investigations
Haemoglobin decreased
|
5.4%
6/111 • Number of events 19
|
|
Investigations
Weight decreased
|
9.9%
11/111 • Number of events 14
|
|
Metabolism and nutrition disorders
Anorexia
|
17.1%
19/111 • Number of events 22
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
19.8%
22/111 • Number of events 60
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.2%
8/111 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
12/111 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
9/111 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.7%
13/111 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.3%
7/111 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
6/111 • Number of events 8
|
|
Nervous system disorders
Dizziness
|
5.4%
6/111 • Number of events 7
|
|
Nervous system disorders
Headache
|
10.8%
12/111 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.6%
14/111 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.8%
12/111 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
6/111 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.2%
8/111 • Number of events 8
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER