A Phase 2 interventional study of IMC-A12 (cixutumumab) and IMC-A12 (cixutumumab) in Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET), Rhabdomyosarcoma and Leiomyosarcoma, sponsored by Eli Lilly and Company. Completed at 22 sites in 7 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-07-17.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
238 studies on the registry are indexed under Rhabdomyosarcoma; 49 are open to participants now.
This study's enrollment of 113 is above the median of 42 across 202 interventional studies indexed under Rhabdomyosarcoma.
Browse Rhabdomyosarcoma studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: IMC-A12 (cixutumumab)
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.
Also known as: cixutumumab, LY3012217
Rhabdomyosarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
Also known as: cixutumumab, LY3012217
Leiomyosarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
Also known as: cixutumumab, LY3012217
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.
Also known as: cixutumumab, LY3012217
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.
Also known as: cixutumumab, LY3012217
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.
Time frame: Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks
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.
Time frame: 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.
Time frame: Baseline to measured PD (up to 105.4 weeks)
Time to Response
Time frame: Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks)
Duration of Response
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through study completion (up to 112.9 weeks)
Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)
Time frame: 30-day safety follow-up
| Milestone | Entire Study Population |
|---|---|
| Started | 113 |
| Received at least 1 dose of study drug | 111 |
| Completed | 103 |
| Not completed | 10 |
| Withdrew: Adverse event | 5 |
| Withdrew: Subject non-compliance | 1 |
| Withdrew: Progressive disease before treatment | 2 |
| Withdrew: Withdrawal of consent | 2 |
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.
| percentage of participants | Ewing's Sarcoma/PNET | Rhabdomyosarcoma | Leiomyosarcoma | Adipocytic Sarcoma | Synovial Sarcoma | Total |
|---|---|---|---|---|---|---|
| Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks | 27.3 (8.5 to 50.4) | 12.5 (2.1 to 32.8) | 25.4 (8.4 to 46.8) | 50.0 (32.9 to 64.9) | 21.4 (5.2 to 44.8) | 31.9 (23.0 to 41.1) |
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.
| weeks | Ewing's Sarcoma/PNET | Rhabdomyosarcoma | Leiomyosarcoma | Adipocytic Sarcoma | Synovial Sarcoma | Total |
|---|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | 6.4 (5.1 to 12.1) | 6.1 (5.1 to 7.3) | 6.0 (5.4 to 11.0) | 12.1 (6.0 to 17.7) | 6.4 (5.6 to 11.9) | 6.7 (6.0 to 11.0) |
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.
| percentage of participants | Ewing's Sarcoma/PNET | Rhabdomyosarcoma | Leiomyosarcoma | Adipocytic Sarcoma | Synovial Sarcoma | Total |
|---|---|---|---|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | 5.6 (0.1 to 27.3) | 0 (0.0 to 19.5) | 0 (0.0 to 15.4) | 2.7 (0.1 to 14.2) | 0 (0.0 to 19.5) | 1.8 (0.2 to 6.4) |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
| weeks | Ewing's Sarcoma/PNET | Rhabdomyosarcoma | Leiomyosarcoma | Adipocytic Sarcoma | Synovial Sarcoma | Total |
|---|---|---|---|---|---|---|
| Overall Survival (OS) | 24.1 (12.6 to 37.6) | 23.6 (8.9 to 52.1) | NA (25.7 to NA) | 46.4 (31.3 to 61.1) | 56.3 (22.3 to 71.3) | 38.4 (31.1 to 52.0) |
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.
| percentage of participants | Ewing's Sarcoma/PNET | Rhabdomyosarcoma | Leiomyosarcoma | Adipocytic Sarcoma | Synovial Sarcoma | Total |
|---|---|---|---|---|---|---|
| Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)] | 33.3 (13.3 to 59.0) | 23.5 (6.8 to 49.9) | 40.9 (20.7 to 63.6) | 56.8 (39.5 to 72.9) | 35.3 (14.2 to 61.7) | 41.4 (32.2 to 51.2) |
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.
| Participants | Entire Study Population |
|---|---|
| Any TEAE | 108 |
| Serious TEAE | 56 |
| Deaths Due to Disease Progression | 10 |
| Death Due to Other Cause | 1 |
| Death Due to AE | 1 |
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Entire Study Population | — | 56/111 (50.5%) | 97/111 (87.4%) |
| Event | Entire Study Population |
|---|---|
| Disease progressionGeneral disorders | 14/111 |
| PainGeneral disorders | 6/111 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/111 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 4/111 |
| PneumoniaInfections and infestations | 3/111 |
| Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/111 |
| Renal failure acuteRenal and urinary disorders | 3/111 |
| Vaginal haemorrhageReproductive system and breast disorders | 1/54 |
| AnaemiaBlood and lymphatic system disorders | 2/111 |
| General physical health deteriorationGeneral disorders | 2/111 |
| Event | Entire Study Population |
|---|---|
| NauseaGastrointestinal disorders | 28/111 |
| FatigueGeneral disorders | 26/111 |
| DiarrhoeaGastrointestinal disorders | 25/111 |
| HyperglycaemiaMetabolism and nutrition disorders | 22/111 |
| AnorexiaMetabolism and nutrition disorders | 19/111 |
| AstheniaGeneral disorders | 17/111 |
| ConstipationGastrointestinal disorders | 16/111 |
| VomitingGastrointestinal disorders | 15/111 |
| CoughRespiratory, thoracic and mediastinal disorders | 14/111 |
| AnaemiaBlood and lymphatic system disorders | 13/111 |
Enrolled participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Median | 47.0 ± 10.3 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 54 |
| Male | 57 |
| Ethnicity (NIH/OMB)(Participants) | Entire Study Population |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 102 |
| Unknown or Not Reported | 1 |
| Race/Ethnicity, Customized(Participants) | Entire Study Population |
|---|---|
| White | 101 |
| Black | 5 |
| Other | 5 |
| Region of Enrollment(Participants) | Entire Study Population |
|---|---|
| France | 15 |
| United States | 50 |
| Poland | 7 |
| Spain | 9 |
| Belgium | 23 |
| Germany | 1 |
| Netherlands | 6 |
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cixutumumab