Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET)Phase 2NCT00668148
A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma
A Phase 2 study testing IMC-A12 (cixutumumab) in people with Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET) and Rhabdomyosarcoma, run by Eli Lilly and Company at 22 sites in 7 countries.
Trial summary
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: 1. Ewing's sarcoma/peripheral neuroectodermal tumor (PNET) 2. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET), Rhabdomyosarcoma, Leiomyosarcoma
- What is being tested?
- IMC-A12 (cixutumumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 22 sitesin 7 countries
- Study dates
- Jul 2008to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically-confirmed sarcoma of one of the following histologies: (1) Ewing's sarcoma / PNET; (2) rhabdomyosarcoma; (3) leiomyosarcoma; (4) adipocytic sarcoma; or (5) synovial sarcoma
- Has measurable disease, at least one lesion ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
- Has at least one measurable lesion located outside of a previously irradiated area
- Has radiographic documentation of disease progression within 6 months prior to study entry
- Has relapsed, refractory, and/or metastatic disease, incurable by surgery, radiotherapy, or other conventional systemic therapy
- Been considered ineligible for systemic chemotherapy or received at least one previous regimen for relapsed, refractory, and/or metastatic disease
Show all 12Show fewer
- Adequate hematologic function
- Has adequate hepatic function
- Has adequate coagulation function
- Has adequate renal function
- Has fasting serum glucose < 120 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN)
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Who cannot join
- Has uncontrolled brain or leptomeningeal metastases
- Not recovered to grade ≤ 1 from adverse events due to agents administered more than 3 weeks prior to study entry
- Is receiving any other investigational agent(s)
- Major surgery, hormonal therapy (other than replacement), chemotherapy, radiotherapy, or any form of investigational therapy within 3 weeks prior to enrollment
- History of treatment with other agents targeting the insulin-like growth factor-I receptor (IGF-IR)
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-A12
Show all 9Show fewer
- Has poorly controlled diabetes mellitus
- Is receiving therapy with immunosuppressive agents
- Is pregnant or breastfeeding
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States7 sites
ImClone Investigational Site
Aurora, Colorado, 80045
ImClone Investigational Site
Columbus, Ohio, 43210
ImClone Investigational Site
Detroit, Michigan, 48201-2014
ImClone Investigational Site
Metairie, Louisiana, 70006-2921
ImClone Investigational Site
Metairie, Louisiana, 70006
ImClone Investigational Site
Orlando, Florida, 32806
ImClone Investigational Site
St Louis, Missouri, 63110
France4 sites
ImClone Investigational Site
Bordeaux, 33076
ImClone Investigational Site
Lyon, 69008
ImClone Investigational Site
Paris, 75231
ImClone Investigational Site
Toulouse, 31052
Spain4 sites
ImClone Investigational Site
Barcelona, 08025
ImClone Investigational Site
Barcelona, 08035
ImClone Investigational Site
Barcelona, 08041
ImClone Investigational Site
Barcelona, 08907
Belgium3 sites
ImClone Investigational Site
Brussels, 1000
ImClone Investigational Site
Leuven, 3000
ImClone Investigational Site
Wilrijk, 2610
Germany2 sites
ImClone Investigational Site
Dresden, 01307
ImClone Investigational Site
Mannheim, 68167
About this study
Official title: A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET
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:
- Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
- rhabdomyosarcoma
- leiomyosarcoma
- adipocytic sarcoma
- synovial sarcoma.
Read more
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.
Read the detailed description
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.
- Conditions
- Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET), Rhabdomyosarcoma, Leiomyosarcoma, Adipocytic Sarcoma, Synovial Sarcoma
- Being tested
- IMC-A12 (cixutumumab)
- Keywords
- Sarcoma, Ewing's sarcoma / peripheral neuroectodermal tumor (PNET);, rhabdomyosarcoma;, leiomyosarcoma;, adipocytic sarcoma, synovial sarcoma
- Medical subject headings
- Rhabdomyosarcoma, Leiomyosarcoma, Sarcoma, Synovial, Sarcoma, Sarcoma, Ewing, Neuroectodermal Tumors, Primitive, Peripheral, Neuroectodermal Tumors, Primitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-A12 (cixutumumab)Biological
Also called cixutumumab, LY3012217
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.
IMC-A12 (cixutumumab)Biological
Also called 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.
IMC-A12 (cixutumumab)Biological
Also called 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.
IMC-A12 (cixutumumab)Biological
Also called 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.
IMC-A12 (cixutumumab)Biological
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| IMC-A12 (cixutumumab) | Experimental | Not described Receives: Biological: IMC-A12 (cixutumumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: Baseline to measured PD (up to 105.4 weeks)
Time to Response
Measured: Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks)
Duration of Response
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through study completion (up to 112.9 weeks)
Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)
Measured: 30-day safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2010
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET)Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E-mail: ClinicalTrials@ ImClone.com, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668148
- Sponsor's protocol ID
- 13925
- Other IDs
- 2007-006719-21, CP13-0707, I5A-IE-JAEC
- Status last verified
- Jun 2018
- First submitted
- 25 Apr 2008
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22682017
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET
- ClinicalTrials.gov ID
- NCT00668148
- Acronym / sponsor ID
- 13925
- Conditions
- Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET), Rhabdomyosarcoma, Leiomyosarcoma, Adipocytic Sarcoma, Synovial Sarcoma
- Keywords
- Sarcoma, Ewing's sarcoma / peripheral neuroectodermal tumor (PNET);, rhabdomyosarcoma;, leiomyosarcoma;, adipocytic sarcoma, synovial sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
- rhabdomyosarcoma
- leiomyosarcoma
- adipocytic sarcoma
- synovial sarcoma.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMC-A12 (cixutumumab) | Experimental | Biological: IMC-A12 (cixutumumab) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically-confirmed sarcoma of one of the following histologies: (1) Ewing's sarcoma / PNET; (2) rhabdomyosarcoma; (3) leiomyosarcoma; (4) adipocytic sarcoma; or (5) synovial sarcoma
- Has measurable disease, at least one lesion ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
- Has at least one measurable lesion located outside of a previously irradiated area
- Has radiographic documentation of disease progression within 6 months prior to study entry
- Has relapsed, refractory, and/or metastatic disease, incurable by surgery, radiotherapy, or other conventional systemic therapy
Key exclusion criteria (9 listed)
- Has uncontrolled brain or leptomeningeal metastases
- Not recovered to grade ≤ 1 from adverse events due to agents administered more than 3 weeks prior to study entry
- Is receiving any other investigational agent(s)
- Major surgery, hormonal therapy (other than replacement), chemotherapy, radiotherapy, or any form of investigational therapy within 3 weeks prior to enrollment
- History of treatment with other agents targeting the insulin-like growth factor-I receptor (IGF-IR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-A12 (cixutumumab)Also: cixutumumab, LY3012217Ewing'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. | Biological | IMC-A12 (cixutumumab) |
| IMC-A12 (cixutumumab)Also: cixutumumab, LY3012217Rhabdomyosarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. | Biological | IMC-A12 (cixutumumab) |
| IMC-A12 (cixutumumab)Also: cixutumumab, LY3012217Leiomyosarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. | Biological | IMC-A12 (cixutumumab) |
| IMC-A12 (cixutumumab)Also: cixutumumab, LY3012217Adipocytic sarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. | Biological | IMC-A12 (cixutumumab) |
| IMC-A12 (cixutumumab)Also: cixutumumab, LY3012217Synovial sarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. | Biological | IMC-A12 (cixutumumab) |
Primary outcome
Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks
Time frame: Baseline to Disease Progression or Death Due to Any Cause Up To 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.
8 secondary outcomes
Progression-Free Survival (PFS)
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)]
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)
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)]
Time frame: Baseline through study completion (up to 105.4 weeks)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22682017Asmane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E-mail: ClinicalTrials@ ImClone.com study director
Eli Lilly and Company
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMC-A12 (cixutumumab) in people with Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET) and Rhabdomyosarcoma, run by Eli Lilly and Company at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, France, Spain, Belgium, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks (time frame: Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00668148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.