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Trial record 27 of 31 for:    IGFBP2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00503685
Recruitment Status : Completed
First Posted : July 19, 2007
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: IMC-A12
Biological: cetuximab
Enrollment 65
Recruitment Details  
Pre-assignment Details Participants with progressive disease (PD) or death are considered having completed study.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description Participants received 10 milligrams/kilogram (mg/kg) IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent. Participants received cetuximab 500 milligrams/square meter (mg/m²) intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with Kirsten rat sarcoma (K-ras) wild-type who experienced confirmed partial response (PR) or stable disease (SD) ≥ 24 weeks on a prior anti-epidermal growth factor receptor (EGFR)-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Period Title: Overall Study
Started 23 22 20
Received at Least 1 Dose of Study Drug 23 21 20
Completed 23 19 18
Not Completed 0 3 2
Reason Not Completed
Adverse Event             0             0             2
Withdrawal by Subject             0             1             0
Protocol Violation             0             1             0
Eligibility Criteria Not Met             0             1             0
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type) Total
Hide Arm/Group Description Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent. Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Total of all reporting groups
Overall Number of Baseline Participants 23 21 20 64
Hide Baseline Analysis Population Description
All randomized/enrolled participants who received at least 1 dose of study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 21 participants 20 participants 64 participants
59.3
(41 to 79)
62.6
(40 to 84)
61.7
(44 to 70)
60.5
(40 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 20 participants 64 participants
Female 14 9 10 33
Male 9 12 10 31
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 20 participants 64 participants
Hispanic or Latino 2 3 2 7
Not Hispanic or Latino 21 18 18 57
Unknown or Not Reported 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 20 participants 64 participants
White 17 17 17 51
Black 4 2 2 8
Asian 1 1 1 3
Hispanic 1 0 0 1
Unknown or Not Reported 0 1 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants 21 participants 20 participants 64 participants
23 21 20 64
1.Primary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response [PR, Objective Response Rate (ORR)]
Hide Description 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.
Time Frame Start of randomization/treatment to date of objective progressive disease (PD) up to 28.3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized/enrolled participants who received at least 1 dose of study drug.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 23 21 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 14.8)
4.8
(0.1 to 23.8)
0.0
(0.0 to 16.8)
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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.
Time Frame Randomization/treatment to measured PD up to 28.3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized/enrolled participants who received at least 1 dose of study drug. The number of participants censored was 0 for IMC-A12 group, 1 for IMC-A12 + cetuximab group and 1 for IMC-A12 + cetuximab (K-ras wild-type) group.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 23 21 20
Median (95% Confidence Interval)
Unit of Measure: weeks
5.9
(5.6 to 5.9)
6.1
(5.6 to 6.4)
9.4
(5.6 to 11.6)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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.
Time Frame Randomization/treatment to date of death from any cause up to 26.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized/enrolled participants who received at least 1 dose of study drug. The number of participants censored was 5 for IMC-A12 group, 4 for IMC-A12 + cetuximab group and 11 for IMC-A12 + cetuximab (K-ras wild-type) group.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 23 21 20
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(3.4 to 7.9)
4.5
(2.8 to 13.3)
10.9 [1] 
(5.5 to NA)
[1]
Upper limit of 95% confidence interval was not estimable due to high censoring rate.
4.Secondary Outcome
Title Duration of Stable Disease (SD)
Hide Description 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.
Time Frame Time from randomization/treatment to first date of PD up to 28.3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized/enrolled participants who received at least 1 dose of the study drug and achieved SD or better. The number of participants censored was 0 for IMC-A12 group, 0 for IMC-A12 + cetuximab group and 1 for IMC-A12 + cetuximab (K-ras wild-type) group.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 3 3 12
Median (95% Confidence Interval)
Unit of Measure: weeks
11.1
(10.7 to 12.3)
15.4
(11.4 to 28.3)
11.6
(9.0 to 17.9)
5.Secondary Outcome
Title Duration of Overall Response
Hide Description 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.
Time Frame Time of response to time of measured PD or death up to 161 days
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Duration of Response for CR or PR data was not collected for analysis due to N=0 CR and N=1 PR.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame Randomization/treatment up to 26.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized/enrolled participants who received at least 1 dose of study drug.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 23 21 20
Measure Type: Count of Participants
Unit of Measure: Participants
18 19 20
7.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Severe Adverse Events
Hide Description 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.
Time Frame Randomization/treatment up to 26.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized/enrolled participants who received at least 1 dose of study drug.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 23 21 20
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs 7 6 4
Death Due to PD 1 0 0
Death Due to SAE 0 1 0
8.Secondary Outcome
Title Maximum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Minimum Concentration (Cmin)
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Area Under Serum Concentration (AUC)
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR, Response Rate) in Participants With Kirsten Rat Sarcoma (K-ras) Mutations
Hide Description The response rate in participants with K-ras mutations was not collected for analysis.
Time Frame Treatment up to 26.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Response rate data was not collected for analysis due to N=0 CR and N=1 PR.
Arm/Group Title IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Expression of Type I Insulin-Like Growth Factor Receptors (IGF-IR)
Hide Description [Not Specified]
Time Frame Randomization/treatment up to 26.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. No data collected for analysis.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Expression of IGF Binding Proteins (IGFBP2, IGFBP3)
Hide Description [Not Specified]
Time Frame Randomization/treatment up to 26.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. No data collected for analysis.
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description:
Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Hide Arm/Group Description Participants received 10 mg/kg IMC-A12 intravenous infusion over 1 hour every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent. Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Participants with K-ras wild-type who experienced confirmed PR or SD ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression were enrolled in this arm.

Participants received cetuximab 500 mg/m² intravenous infusion over 2 hours followed by 10 mg/kg IMC-A12 intravenous infusion over 1 hour. This sequence was repeated every 2 weeks until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

All-Cause Mortality
IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/23 (30.43%)      6/21 (28.57%)      4/20 (20.00%)    
Blood and lymphatic system disorders       
Anaemia  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Thrombocytopenia  1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorders       
Abdominal pain  1  2/23 (8.70%)  3 0/21 (0.00%)  0 1/20 (5.00%)  1
Abdominal pain upper  1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Constipation  1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Haematemesis  1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Nausea  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Small intestinal obstruction  1  1/23 (4.35%)  1 0/21 (0.00%)  0 1/20 (5.00%)  1
Vomiting  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
General disorders       
Asthenia  1  2/23 (8.70%)  2 0/21 (0.00%)  0 0/20 (0.00%)  0
Disease progression  1  2/23 (8.70%)  2 1/21 (4.76%)  1 0/20 (0.00%)  0
Fatigue  1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Infusion related reaction  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Pyrexia  1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Hepatobiliary disorders       
Bile duct obstruction  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Cholangitis  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations       
Bacteraemia  1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Pneumonia  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Sepsis  1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Urinary tract infection  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Post procedural bile leak  1  0/23 (0.00%)  0 1/21 (4.76%)  3 0/20 (0.00%)  0
Investigations       
Aspartate aminotransferase increased  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Blood alkaline phosphatase increased  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Blood bilirubin increased  1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  1/23 (4.35%)  1 1/21 (4.76%)  1 0/20 (0.00%)  0
Hyperglycaemia  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Back pain  1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Pain in extremity  1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders       
Headache  1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Renal and urinary disorders       
Acute prerenal failure  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Renal failure acute  1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Ureteric obstruction  1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/23 (4.35%)  1 0/21 (0.00%)  0 1/20 (5.00%)  1
Pleural effusion  1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IMC-A12 IMC-A12 + Cetuximab IMC-A12 + Cetuximab (K-ras Wild-type)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/23 (78.26%)      19/21 (90.48%)      20/20 (100.00%)    
Blood and lymphatic system disorders       
Anaemia  1  1/23 (4.35%)  1 2/21 (9.52%)  3 0/20 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  3/23 (13.04%)  3 2/21 (9.52%)  2 1/20 (5.00%)  1
Abdominal pain upper  1  2/23 (8.70%)  2 2/21 (9.52%)  2 1/20 (5.00%)  1
Constipation  1  4/23 (17.39%)  4 2/21 (9.52%)  2 2/20 (10.00%)  2
Diarrhoea  1  2/23 (8.70%)  2 4/21 (19.05%)  6 4/20 (20.00%)  5
Nausea  1  3/23 (13.04%)  4 6/21 (28.57%)  9 3/20 (15.00%)  3
Stomatitis  1  1/23 (4.35%)  1 1/21 (4.76%)  1 3/20 (15.00%)  3
Vomiting  1  2/23 (8.70%)  3 3/21 (14.29%)  5 4/20 (20.00%)  4
General disorders       
Fatigue  1  7/23 (30.43%)  9 8/21 (38.10%)  11 8/20 (40.00%)  9
Mucosal inflammation  1  0/23 (0.00%)  0 2/21 (9.52%)  2 0/20 (0.00%)  0
Pyrexia  1  3/23 (13.04%)  3 2/21 (9.52%)  2 1/20 (5.00%)  1
Infections and infestations       
Paronychia  1  0/23 (0.00%)  0 1/21 (4.76%)  2 2/20 (10.00%)  3
Investigations       
Blood bilirubin increased  1  2/23 (8.70%)  3 1/21 (4.76%)  1 0/20 (0.00%)  0
Weight decreased  1  4/23 (17.39%)  5 2/21 (9.52%)  3 0/20 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  3/23 (13.04%)  3 3/21 (14.29%)  5 5/20 (25.00%)  7
Decreased appetite  1  2/23 (8.70%)  2 3/21 (14.29%)  3 1/20 (5.00%)  1
Hypokalaemia  1  0/23 (0.00%)  0 3/21 (14.29%)  4 0/20 (0.00%)  0
Hypomagnesaemia  1  0/23 (0.00%)  0 4/21 (19.05%)  10 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  3/23 (13.04%)  4 2/21 (9.52%)  3 1/20 (5.00%)  1
Myalgia  1  0/23 (0.00%)  0 1/21 (4.76%)  1 2/20 (10.00%)  2
Nervous system disorders       
Dizziness  1  3/23 (13.04%)  3 2/21 (9.52%)  4 1/20 (5.00%)  1
Dysgeusia  1  2/23 (8.70%)  2 2/21 (9.52%)  2 2/20 (10.00%)  2
Headache  1  1/23 (4.35%)  1 2/21 (9.52%)  2 6/20 (30.00%)  6
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/23 (0.00%)  0 2/21 (9.52%)  2 1/20 (5.00%)  1
Dyspnoea  1  7/23 (30.43%)  7 3/21 (14.29%)  4 1/20 (5.00%)  1
Dyspnoea exertional  1  0/23 (0.00%)  0 2/21 (9.52%)  2 0/20 (0.00%)  0
Epistaxis  1  1/23 (4.35%)  1 2/21 (9.52%)  2 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis acneiform  1  0/23 (0.00%)  0 12/21 (57.14%)  19 9/20 (45.00%)  14
Dry skin  1  0/23 (0.00%)  0 3/21 (14.29%)  3 7/20 (35.00%)  7
Nail disorder  1  0/23 (0.00%)  0 1/21 (4.76%)  1 2/20 (10.00%)  2
Pruritus  1  0/23 (0.00%)  0 2/21 (9.52%)  2 4/20 (20.00%)  5
Rash  1  0/23 (0.00%)  0 3/21 (14.29%)  4 1/20 (5.00%)  1
Rash macular  1  0/23 (0.00%)  0 1/21 (4.76%)  1 6/20 (30.00%)  7
Vascular disorders       
Hypertension  1  0/23 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00503685     History of Changes
Other Study ID Numbers: 13936
CP02-0657 ( Other Identifier: ImClone, LLC )
CP13-0605 ( Other Identifier: ImClone, LLC )
I5A-IE-JAEL ( Other Identifier: Eli Lilly and Company )
First Submitted: July 17, 2007
First Posted: July 19, 2007
Results First Submitted: March 17, 2018
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018