Trial Outcomes & Findings for Study of IMC-11F8 in Participants With Colorectal Cancer (NCT NCT00835185)

Last Updated: 2016-01-29

Results Overview

CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) \* 100.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Up to 30 Months

Results posted on

2016-01-29

Participant Flow

Participants with known best overall response and off study treatment were considered to be completed.

Participant milestones

Participant milestones
Measure	IMC-11F8 (Necitumumab) + mFOLFOX-6 On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown: * 800 milligrams (mg) IMC-11F8 intravenous (IV) infusion over 50 minutes * 85 milligrams per meter square (mg/m²) oxaliplatin IV infusion over 2 hours * 400 mg/m² folinic acid * 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by * A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent or until other criteria for treatment discontinuation were met.
Overall Study STARTED	44
Overall Study Received at Least 1 Dose of Study Drug	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of IMC-11F8 in Participants With Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMC-11F8 (Necitumumab) + mFOLFOX-6 n=44 Participants On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown: * 800 mg IMC-11F8 IV infusion over 50 minutes * 85 mg/m² oxaliplatin IV infusion over 2 hours * 400 mg/m² folinic acid * 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by * A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Age, Continuous	63.3 years STANDARD_DEVIATION 11.75 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Belgium	13 participants n=5 Participants
Region of Enrollment Spain	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 Months

Population: All enrolled participants who received any quantity of study drug.

Outcome measures

Outcome measures
Measure	IMC-11F8 (Necitumumab) + mFOLFOX-6 n=44 Participants On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown: * 800 mg IMC-11F8 IV infusion over 50 minutes * 85 mg/m² oxaliplatin IV infusion over 2 hours * 400 mg/m² folinic acid * 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by * A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )	63.6 percentage of participants Interval 47.8 to 77.6

SECONDARY outcome

Timeframe: First dose to date of death from any cause up to 30 months

Population: All enrolled participants who received any quantity of study drug. Participants censored =14.

OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact.

Outcome measures

Outcome measures
Measure	IMC-11F8 (Necitumumab) + mFOLFOX-6 n=44 Participants On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown: * 800 mg IMC-11F8 IV infusion over 50 minutes * 85 mg/m² oxaliplatin IV infusion over 2 hours * 400 mg/m² folinic acid * 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by * A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Survival (OS)	22.5 months Interval 11.0 to 30.0

SECONDARY outcome

Timeframe: First dose to measured PD or death up to 30 months

Population: All enrolled participants who received any quantity of study drug. Participants censored =13.

PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. 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 earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period.

Outcome measures

Outcome measures
Measure	IMC-11F8 (Necitumumab) + mFOLFOX-6 n=44 Participants On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown: * 800 mg IMC-11F8 IV infusion over 50 minutes * 85 mg/m² oxaliplatin IV infusion over 2 hours * 400 mg/m² folinic acid * 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by * A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Progression-Free Survival (PFS)	10.0 months Interval 7.0 to 12.0

SECONDARY outcome

Timeframe: First dose to end of treatment and 30-day post treatment follow-up up to 31 months

Population: All enrolled participants who received any quantity of study drug.

The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure	IMC-11F8 (Necitumumab) + mFOLFOX-6 n=44 Participants On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown: * 800 mg IMC-11F8 IV infusion over 50 minutes * 85 mg/m² oxaliplatin IV infusion over 2 hours * 400 mg/m² folinic acid * 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by * A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death AEs	44 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death SAEs	16 participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death Deaths	3 participants

SECONDARY outcome

Timeframe: Time of response to time of measured PD or death up to 30 months

Population: All enrolled participants who received any quantity of study drug and had confirmed CR or PR. Participants censored =2.

The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact.

Outcome measures

Outcome measures
Measure	IMC-11F8 (Necitumumab) + mFOLFOX-6 n=28 Participants On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown: * 800 mg IMC-11F8 IV infusion over 50 minutes * 85 mg/m² oxaliplatin IV infusion over 2 hours * 400 mg/m² folinic acid * 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by * A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Duration of Response	10.0 months Interval 7.0 to 16.0

SECONDARY outcome

Timeframe: Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)

Population: All participants who received any amount of study drug and were IMC-11F8 antibody negative at baseline.

A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals.