Trial Outcomes & Findings for A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of Participants With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab (NCT NCT00845039)
NCT ID: NCT00845039
Last Updated: 2018-07-02
Results Overview
TERMINATED
PHASE2
4 participants
Approximately 18 Weeks
2018-07-02
Participant Flow
Participant milestones
| Measure |
Cetuximab + Irinotecan
500 milligrams per square meter (mg/m²) of Cetuximab administered by intravenous (IV) infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
|
Cetuximab + IMC-A12 + Irinotecan
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 milligrams per kilogram (mg/kg) of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of Participants With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab
Baseline characteristics by cohort
| Measure |
Cetuximab + Irinotecan
n=2 Participants
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
|
Cetuximab + IMC-A12 + Irinotecan
n=2 Participants
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
n=5 Participants
|
59.5 years
n=7 Participants
|
55.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 18 WeeksPopulation: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to 26.3 monthsPopulation: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to 26.3 monthsPopulation: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to 26.3 monthsPopulation: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to 26.3 monthsPopulation: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to 26.3 monthsPopulation: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeksPopulation: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, after Cycle 3 (14-day cycle), study discontinuation 30-day follow-up (up to 26.3 months)Population: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeksPopulation: Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26.3 months post-randomization up to 30-day post-treatment follow-upPopulation: All randomized participants who received at least 1 dose of study drug.
Reported are the deaths during the 30-day follow-up period regardless of causality.
Outcome measures
| Measure |
Cetuximab + Irinotecan
n=2 Participants
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
|
Cetuximab + IMC-A12 + Irinotecan
n=2 Participants
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day until disease progression or participant intolerance.
|
|---|---|---|
|
The Number of Participants Who Died During 30-Day Follow-Up
|
1 Participants
|
1 Participants
|
Adverse Events
Cetuximab + Irinotecan
Cetuximab + IMC-A12 + Irinotecan
Serious adverse events
| Measure |
Cetuximab + Irinotecan
n=2 participants at risk
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
|
Cetuximab + IMC-A12 + Irinotecan
n=2 participants at risk
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day until disease progression or participant intolerance.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
Other adverse events
| Measure |
Cetuximab + Irinotecan
n=2 participants at risk
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
|
Cetuximab + IMC-A12 + Irinotecan
n=2 participants at risk
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day until disease progression or participant intolerance.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Abdominal pain lower
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 4
|
50.0%
1/2 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 4
|
0.00%
0/2
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Weight increased
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Number of events 3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Nervous system disorders
Hypoaesthesia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Restless legs syndrome
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2
|
50.0%
1/2 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER