A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma

Phase 2

Completed

• Conditions: Synovial Sarcoma; Rhabdomyosarcoma; Leiomyosarcoma; Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET); Adipocytic Sarcoma
• Interventions: Biological: IMC-A12 (cixutumumab)

• Registration Number: NCT00668148
• Lead Sponsor: Eli Lilly and Company

Brief 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. rhabdomyosarcoma

3. leiomyosarcoma

4. adipocytic sarcoma

5. 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 Timeline

• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Study Start: 2008-07
• Disposition First Submitted: 2010-09-01
• Disposition First Submitted QC: 2010-09-01
• Disposition First Posted: 2010-09-06
• Primary Completion: 2010-10
• Study Completion: 2012-02
• Results First Submitted: 2018-03-17
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Results First Posted: 2018-07-17
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMC-A12 (cixutumumab)	IMC-A12 (cixutumumab)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]	Baseline to measured PD (up to 105.4 weeks)	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 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)
Progression-Free Survival (PFS)	Baseline to measured PD (up to 105.4 weeks)	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.
Overall Survival (OS)	Baseline to date of death from any cause (up to 112.9 weeks)	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.
Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)]	Baseline through study completion (up to 105.4 weeks)	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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths	Baseline through study completion (up to 112.9 weeks)	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.
Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)	30-day safety follow-up

Trial Locations

Locations (1)

ImClone Investigational Site; 🇪🇸 Barcelona, Spain