A Phase 2 interventional study of Panitumumab and FOLFIRI in Metastatic Colorectal Cancer, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Amgen · Phase 2, Interventional, and Treatment
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).
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 154 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
Drug: Panitumumab · Drug: FOLFIRI
Administered by intravenous infusion
Also known as: Vectibix
FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m², leucovorin 400 mg/m², 5-fluorouracil bolus 400 mg/m², 5-fluorouracil infusion 2400 mg/m².
Objective Response Rate
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 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
Time frame: 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 by 17 Weeks
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.
Time frame: Up to Week 17
Disease Control Rate
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.
Time frame: 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
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.
Time frame: 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 Initial Objective Response
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.
Time frame: 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.
Progression-free Survival
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.
Time frame: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
Time to Disease Progression
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.
Time frame: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
Duration of Stable Disease
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.
Time frame: 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 Treatment Failure
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.
Time frame: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
Time to Disease Relapse Following Surgical Intervention
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 last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods.
Time frame: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
Resection Rate
The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.
Time frame: From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.
A total of 169 patients were screened, of whom 154 were enrolled into this study at 36 study centers in Austria, Belgium, France, Germany, and Sweden from 9 May 2007 through 18 June 2008. Results are reported through the primary analysis data cut-off date of 18 June 2009 (12 months after the last patient was enrolled).
| Milestone | Panitumumab Plus FOLFIRI |
|---|---|
| Started | 154 |
| Completed | 112 |
| Not completed | 42 |
| Withdrew: Ongoing at data cut-off | 12 |
| Withdrew: Adverse event | 2 |
| Withdrew: Death | 16 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Protocol-specified criteria | 2 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Other - not specified | 3 |
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 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
| percentage of participants | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Objective Response Rate | 56.47 (45.28 to 67.20) | 37.93 (25.51 to 51.63) |
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.
| percentage of participants | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Objective Response by 17 Weeks | 49.41 (38.39 to 60.48) | 34.48 (22.49 to 48.12) |
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.
| percentage of participants | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Disease Control Rate | 90.59 (82.29 to 95.85) | 89.66 (78.83 to 96.11) |
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.
| months | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Duration of Response | 13.0 (9.3 to 13.0) | 7.4 (5.4 to 8.8) |
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.
| months | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Time to Initial Objective Response | 3.8 (3.4 to NA) | NA (5.5 to NA) |
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.
| months | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Progression-free Survival | 8.9 (7.6 to 14.3) | 7.2 (5.6 to 7.8) |
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.
| months | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Time to Disease Progression | 11.2 (7.6 to 14.8) | 7.3 (5.7 to 8.9) |
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.
| months | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Duration of Stable Disease | 5.9 (5.8 to 7.6) | 6.1 (4.8 to 7.4) |
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.
| months | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Time to Treatment Failure | 6.9 (6.2 to 7.6) | 5.8 (5.3 to 6.8) |
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 last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods.
| months | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Time to Disease Relapse Following Surgical Intervention | NA (NA to NA) | NA (NA to NA) |
The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.
| percentage of participants | Wild-type KRAS | Mutant KRAS |
|---|---|---|
| Resection Rate | 15.12 (8.30 to 24.46) | 6.78 (1.88 to 16.46) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Panitumumab Plus FOLFIRI | — | 84/154 (54.5%) | 154/154 (100%) |
| Event | Panitumumab Plus FOLFIRI |
|---|---|
| DIARRHOEAGastrointestinal disorders | 21/154 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 11/154 |
| NEUTROPENIABlood and lymphatic system disorders | 6/154 |
| VOMITINGGastrointestinal disorders | 6/154 |
| FATIGUEGeneral disorders | 5/154 |
| PYREXIAGeneral disorders | 5/154 |
| DEHYDRATIONMetabolism and nutrition disorders | 5/154 |
| ABDOMINAL PAINGastrointestinal disorders | 4/154 |
| CATHETER RELATED COMPLICATIONGeneral disorders | 4/154 |
| CHEST PAINGeneral disorders | 4/154 |
| Event | Panitumumab Plus FOLFIRI |
|---|---|
| DIARRHOEAGastrointestinal disorders | 119/154 |
| NAUSEAGastrointestinal disorders | 85/154 |
| RASHSkin and subcutaneous tissue disorders | 64/154 |
| DRY SKINSkin and subcutaneous tissue disorders | 61/154 |
| ACNESkin and subcutaneous tissue disorders | 55/154 |
| ALOPECIASkin and subcutaneous tissue disorders | 52/154 |
| NEUTROPENIABlood and lymphatic system disorders | 50/154 |
| FATIGUEGeneral disorders | 49/154 |
| CONSTIPATIONGastrointestinal disorders | 46/154 |
| ASTHENIAGeneral disorders | 42/154 |
| Age, Continuous(years) | Panitumumab Plus FOLFIRI |
|---|---|
| Mean | 62.7 ± 10.6 |
| Sex: Female, Male(Participants) | Panitumumab Plus FOLFIRI |
|---|---|
| Female | 49 |
| Male | 105 |
| Race/Ethnicity, Customized(participants) | Panitumumab Plus FOLFIRI |
|---|---|
| Black or African American | 2 |
| Hispanic or Latino | 1 |
| Japanese | 1 |
| White or Caucasian | 150 |
| Kirsten Rat Sarcoma-2 Virus (KRAS) Mutation Status(participants) | Panitumumab Plus FOLFIRI |
|---|---|
| Wild-type KRAS | 86 |
| Mutant KRAS | 59 |
| Unevaluable KRAS | 9 |
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