Study Using IMC-A12 (Cixutumumab) With or Without Cetuximab in Participants With Metastatic Colorectal Cancer Who Have Failed a Treatment Regimen That Consisted of a Prior Anti-EGFR Therapy

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Biological: IMC-A12; Biological: cetuximab

• Registration Number: NCT00503685
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Participants with metastatic Colorectal Cancer (mCRC) who have progressed on a prior Anti-epidermal growth factor receptor (EGFR) regimen randomized to receive IMC-A12 monotherapy or combination therapy with cetuximab to assess response, survival, durations of response, safety and tolerability as well as pharmacodynamics of IMC-A12 and cetuximab

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-18
• Study First Posted: 2007-07-19
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2010-10-12
• Disposition First Submitted QC: 2010-10-12
• Disposition First Posted: 2010-10-19
• Results First Submitted: 2018-03-17
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-02
• Last Update Submitted: 2018-05-02
• Results First Posted: 2018-06-06
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMC-A12	IMC-A12	Administered every 2 weeks
IMC-A12 + cetuximab	cetuximab	Administered every 2 weeks
IMC-A12 + cetuximab [Kirsten rat sarcoma (K-ras) wild-type]	cetuximab	Participants who have experienced confirmed partial response (PR) or stable disease (SD) ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression are enrolled in this arm.
IMC-A12 + cetuximab	IMC-A12	Administered every 2 weeks
IMC-A12 + cetuximab [Kirsten rat sarcoma (K-ras) wild-type]	IMC-A12	Participants who have experienced confirmed partial response (PR) or stable disease (SD) ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression are enrolled in this arm.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Response (CR) or Partial Response [PR, Objective Response Rate (ORR)]	Start of randomization/treatment to date of objective progressive disease (PD) up to 28.3 weeks	ORR is the percentage of participants with a confirmed CR or PR, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from start of the treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Randomization/treatment to measured PD up to 28.3 weeks	PFS was defined as the duration from the date of randomization/treatment to the date of PD or death from any cause. PD was determined using RECIST criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the cutoff date. Participants who began a new antitumor treatment before evidence of PD were categorized as PD.
Duration of Stable Disease (SD)	Time from randomization/treatment to first date of PD up to 28.3 weeks	The duration of SD is measured from the date of randomization/treatment until the date of PD. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. RECIST criteria version 1.0 was used to asses PR and PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants who had no PD or death at the time of the data inclusion cutoff, duration of SD was censored at their last tumor assessment prior to the cutoff date.
Number of Participants Reporting Treatment-Emergent Severe Adverse Events	Randomization/treatment up to 26.9 months	Data presented are the number of participants who experienced serious adverse events (SAEs) or death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Percentage of Participants With Complete Response (CR) or Partial Response (PR, Response Rate) in Participants With Kirsten Rat Sarcoma (K-ras) Mutations	Treatment up to 26.9 months	The response rate in participants with K-ras mutations was not collected for analysis.
Overall Survival (OS)	Randomization/treatment to date of death from any cause up to 26.9 months	OS is defined as the duration from the date of randomization/treatment to the date of death from any cause. Participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.
Expression of IGF Binding Proteins (IGFBP2, IGFBP3)	Randomization/treatment up to 26.9 months
Duration of Overall Response	Time of response to time of measured PD or death up to 161 days	The duration of overall response (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of PD or death due to any cause. CR, PR and PD were determined using RECIST criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of overall response was censored at their last tumor assessment prior to the cutoff date. Duration of overall response was not analyzed due to low number of participants with CR or PR.
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)	Randomization/treatment up to 26.9 months	Data presented are the number of participants who experienced nonserious adverse events (AEs) during the study including the 30-day follow-up. A summary of serious AEs (SAEs) and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Maximum Concentration (Cmax)	Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)
Minimum Concentration (Cmin)	Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)
Area Under Serum Concentration (AUC)	Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)
Expression of Type I Insulin-Like Growth Factor Receptors (IGF-IR)	Randomization/treatment up to 26.9 months

Trial Locations

Locations (1)

ImClone Investigational Site; 🇺🇸 New York, New York, United States