18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.
Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Group
Value
95% CI
Wild-type KRAS - Panitumumab Plus FOLFIRI
5.9
5.5 – 6.7
Wild-type KRAS - FOLFIRI Alone
3.9
3.7 – 5.3
Mutant KRAS - Panitumumab Plus FOLFIRI
5.0
3.8 – 5.6
Mutant KRAS - FOLFIRI Alone
4.9
3.6 – 5.6
Overall SurvivalPrimary· From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.
Group
Value
95% CI
Wild-type KRAS - Panitumumab Plus FOLFIRI
14.5
13.0 – 16.0
Wild-type KRAS - FOLFIRI Alone
12.5
11.2 – 14.2
Mutant KRAS - Panitumumab Plus FOLFIRI
11.8
10.4 – 13.3
Mutant KRAS - FOLFIRI Alone
11.1
10.3 – 12.4
Percentage of Participants With an Objective ResponseSecondary· Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.
Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progressi
Group
Value
95% CI
Wild-type KRAS - Panitumumab Plus FOLFIRI
35.35
29.92 – 41.08
Wild-type KRAS - FOLFIRI Alone
9.82
6.63 – 13.89
Mutant KRAS - Panitumumab Plus FOLFIRI
13.36
9.26 – 18.43
Mutant KRAS - FOLFIRI Alone
13.92
9.78 – 19.00
Time to Disease ProgressionSecondary· From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Group
Value
95% CI
Wild-type KRAS - Panitumumab Plus FOLFIRI
7.3
5.9 – 7.5
Wild-type KRAS - FOLFIRI Alone
5.3
3.9 – 5.7
Mutant KRAS - Panitumumab Plus FOLFIRI
5.5
4.5 – 5.7
Mutant KRAS - FOLFIRI Alone
5.5
4.2 – 5.7
Duration of ResponseSecondary· From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
Group
Value
95% CI
Wild-type KRAS - Panitumumab Plus FOLFIRI
7.6
6.7 – 9.4
Wild-type KRAS - FOLFIRI Alone
6.6
5.7 – 10.4
Mutant KRAS - Panitumumab Plus FOLFIRI
6.0
5.4 – 7.4
Mutant KRAS - FOLFIRI Alone
7.4
4.0 – 8.1
Number of Participants With Adverse Events (AEs)Secondary· From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.
A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?"
Any adverse event
Group
Value
95% CI
Panitumumab Plus FOLFIRI
584
FOLFIRI Alone
573
Serious adverse event
Group
Value
95% CI
Panitumumab Plus FOLFIRI
232
FOLFIRI Alone
175
Leading to discontinuation of any study drug
Group
Value
95% CI
Panitumumab Plus FOLFIRI
123
FOLFIRI Alone
64
Treatment-related adverse event (TRAE)
Group
Value
95% CI
Panitumumab Plus FOLFIRI
577
FOLFIRI Alone
542
Serious treatment-related adverse event
Group
Value
95% CI
Panitumumab Plus FOLFIRI
124
FOLFIRI Alone
90
TRAE leading to discontinuation of any study drug
Group
Value
95% CI
Panitumumab Plus FOLFIRI
97
FOLFIRI Alone
34
Adverse events — posted to ClinicalTrials.gov
Time frame: The median treatment period was approximately 6.2 months in the Panitumumab plus FOLFIRI arm, and 4.7 months in the FOLFIRI Alone arm..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Panitumumab Plus FOLFIRI
Serious: 232/587 (40%)
Deaths: —
FOLFIRI Alone
Serious: 175/594 (29%)
Deaths: —
Serious adverse events (287 terms)
Reaction
System
Panitumumab Plus FOLFIRI
FOLFIRI Alone
Diarrhoea
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
NCT07094113 — AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
· Phase 1
· recruiting
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 23 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00339183.