Trial · NCT00418938
SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial
NCT00418938, Phase 2, Completed, Amgen; results first posted 2014-03-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial. Trials, record NCT00418938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00418938
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial
- NCT number
- NCT00418938
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 266 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Cancer, Colon Cancer, Colorectal Cancer, Metastatic Cancer, Rectal Cancer, Metastatic Colorectal Cancer
- Interventions
- Panitumumab, Bevacizumab, Leucovorin, Irinotecan, 5-Fluorouracil
- First posted
- 2007-01-05
- Last updated
- 2018-10-17
- Results first posted
- 2014-03-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | From randomization up to 65 months. | Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later). |
| Secondary | Overall Survival | From randomization up to 65 months. | Overall survival is defined as time from the date of randomization to the date of death due to any cause. Subjects who have not died or are lost to follow-up at the analysis cutoff date will be censored at their last contact date. |
| Secondary | Objective Response Rate | From randomization up to 65 months. | Objective response rate is defined as incidence of either a confirmed complete response (CR) or partial response (PR) on study up to starting a new anti-tumor therapy and will be based on modified RECIST version 1.0 (responder) by central assessment. |
| Secondary | Time to Response | From randomization up to 65 months. | Time to response is defined as time from the date of randomization to the date of first confirmed objective response |
| Secondary | Time to Progression | From randomization up to 65 months. | Time to progression is defined as time from the date of randomization to the date of radiographic disease progression per modified RECIST version 1.0 (per central assessment). |
| Secondary | Disease Control | From randomization up to 65 months. | Disease control is defined as incidence of objective response or stable disease on study up to starting a new anti-tumor therapy. |
| Secondary | Duration of Response | From randomization up to 65 months. | Duration of response is defined as time from first confirmed objective response to disease progression per modified RECIST version 1.0 (by central assessment). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | From randomization up to 65 months. | Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status. | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization up to 65 months. | Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status. | months | MEDIAN |
| SECONDARY | Objective Response Rate | From randomization up to 65 months. | Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status. | % of patients | NUMBER |
| SECONDARY | Time to Response | From randomization up to 65 months. | Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status. | months | MEDIAN |
| SECONDARY | Time to Progression | From randomization up to 65 months. | Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status. | months | MEDIAN |
| SECONDARY | Disease Control | From randomization up to 65 months. | Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status. | % of participants | NUMBER |
| SECONDARY | Duration of Response | From randomization up to 65 months. | Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Panitumumab Plus FOLFIRI | Wild-type KRAS (n=91,91) | 7.7 | 95% Confidence Interval 5.7 to 11.8 | months |
| Progression-free Survival (PFS) | Bevacizumab Plus FOLFIRI | Wild-type KRAS (n=91,91) | 9.2 | 95% Confidence Interval 7.8 to 10.6 | months |
| Progression-free Survival (PFS) | Panitumumab Plus FOLFIRI | Mutant KRAS (n=36,32) | 3.7 | 95% Confidence Interval 2.7 to 5.5 | months |
| Progression-free Survival (PFS) | Bevacizumab Plus FOLFIRI | Mutant KRAS (n=36,32) | 6.4 | 95% Confidence Interval 3.5 to 17.1 | months |
| Overall Survival | Panitumumab Plus FOLFIRI | Wild-type KRAS (n=91,91) | 18.0 | 95% Confidence Interval 13.5 to 21.7 | months |
| Overall Survival | Bevacizumab Plus FOLFIRI | Wild-type KRAS (n=91,91) | 21.4 | 95% Confidence Interval 16.5 to 24.6 | months |
| Overall Survival | Panitumumab Plus FOLFIRI | Mutant KRAS (n=36,32) | 8.7 | 95% Confidence Interval 6.1 to 14.5 | months |
| Overall Survival | Bevacizumab Plus FOLFIRI | Mutant KRAS (n=36,32) | 13.5 | 95% Confidence Interval 9.1 to 14.3 | months |
| Objective Response Rate | Panitumumab Plus FOLFIRI | Wild-type KRAS (n=91,91) | 32.18 | 95% Confidence Interval 22.56 to 43.06 | % of patients |
| Objective Response Rate | Bevacizumab Plus FOLFIRI | Wild-type KRAS (n=91,91) | 19.28 | 95% Confidence Interval 11.44 to 29.41 | % of patients |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Panitumumab Plus FOLFIRI | 133 | |
| Overall Study | STARTED | Bevacizumab Plus FOLFIRI | 131 | |
| Overall Study | COMPLETED | Panitumumab Plus FOLFIRI | 109 | |
| Overall Study | COMPLETED | Bevacizumab Plus FOLFIRI | 108 | |
| Overall Study | NOT COMPLETED | Panitumumab Plus FOLFIRI | 24 | |
| Overall Study | NOT COMPLETED | Bevacizumab Plus FOLFIRI | 23 |
Source ClinicalTrials.gov
Adverse events340
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Panitumumab Plus FOLFIRI | 28 | 133 | |
| other | Anaemia | Blood and lymphatic system disorders | Bevacizumab Plus FOLFIRI | 30 | 131 | |
| other | Leukopenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFIRI | 11 | 133 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab Plus FOLFIRI | 14 | 131 | |
| other | Neutropenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFIRI | 44 | 133 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bevacizumab Plus FOLFIRI | 53 | 131 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFIRI | 14 | 133 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab Plus FOLFIRI | 19 | 131 | |
| other | Conjunctivitis | Eye disorders | Panitumumab Plus FOLFIRI | 11 | 133 | |
| other | Conjunctivitis | Eye disorders | Bevacizumab Plus FOLFIRI | 3 | 131 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panitumumab Plus FOLFIRI | ||
| Total, all-cause mortality | Bevacizumab Plus FOLFIRI | ||
| Total, other adverse events | Panitumumab Plus FOLFIRI | 133 | 133 |
| Total, other adverse events | Bevacizumab Plus FOLFIRI | 129 | 131 |
| Total, serious adverse events | Panitumumab Plus FOLFIRI | 61 | 133 |
| Total, serious adverse events | Bevacizumab Plus FOLFIRI | 39 | 131 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25982297 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Panitumumab Plus FOLFIRI vs Bevacizumab Plus FOLFIRI: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00418938
GET https://conductscience.org/api/trials/v1/NCT00418938/results?page=2