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.
Objective Response RatePrimary· Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.
Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.
Partial Response (PR): At least a
Group
Value
95% CI
Wild-type KRAS
56.47
45.28 – 67.20
Mutant KRAS
37.93
25.51 – 51.63
Objective Response by 17 WeeksSecondary· Up to Week 17
The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.
Group
Value
95% CI
Wild-type KRAS
49.41
38.39 – 60.48
Mutant KRAS
34.48
22.49 – 48.12
Disease Control RateSecondary· Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks
The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST v1.0 criteria as assessed by the Investigator.
Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.
Group
Value
95% CI
Wild-type KRAS
90.59
82.29 – 95.85
Mutant KRAS
89.66
78.83 – 96.11
Duration of ResponseSecondary· Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.
Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method.
Group
Value
95% CI
Wild-type KRAS
13.0
9.3 – 13.0
Mutant KRAS
7.4
5.4 – 8.8
Time to Initial Objective ResponseSecondary· Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.
Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods.
Group
Value
95% CI
Wild-type KRAS
3.8
3.4 – NA
Mutant KRAS
NA
5.5 – NA
Progression-free SurvivalSecondary· From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods.
Group
Value
95% CI
Wild-type KRAS
8.9
7.6 – 14.3
Mutant KRAS
7.2
5.6 – 7.8
Time to Disease ProgressionSecondary· From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods.
Group
Value
95% CI
Wild-type KRAS
11.2
7.6 – 14.8
Mutant KRAS
7.3
5.7 – 8.9
Duration of Stable DiseaseSecondary· Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.
Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods.
Group
Value
95% CI
Wild-type KRAS
5.9
5.8 – 7.6
Mutant KRAS
6.1
4.8 – 7.4
Time to Treatment FailureSecondary· From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods.
Group
Value
95% CI
Wild-type KRAS
6.9
6.2 – 7.6
Mutant KRAS
5.8
5.3 – 6.8
Time to Disease Relapse Following Surgical InterventionSecondary· From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their
Group
Value
95% CI
Wild-type KRAS
NA
NA – NA
Mutant KRAS
NA
NA – NA
Resection RateSecondary· From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.
Group
Value
95% CI
Wild-type KRAS
15.12
8.30 – 24.46
Mutant KRAS
6.78
1.88 – 16.46
Adverse events — posted to ClinicalTrials.gov
Time frame: The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 6.6 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
· EARLY_PHASE1
· not yet recruiting
NCT07172919 — A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
· Phase 2
· recruiting
NCT07094113 — AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
· Phase 1
· recruiting
NCT06245356 — Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic C
· Phase 2
· recruiting
NCT06490536 — The Sagittarius Trial
· Phase 3
· 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: 19 November 2019
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/NCT00508404.