Trial · NCT01001377
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
NCT01001377, Phase 3, Completed, Amgen; results first posted 2014-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer. Trials, record NCT01001377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01001377
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
- NCT number
- NCT01001377
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,010 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Cetuximab, Panitumumab
- First posted
- 2009-10-26
- Last updated
- 2022-09-21
- Other registries' IDs
- eudract:2009-010715-32
- Results first posted
- 2014-03-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date. |
| Secondary | Progression-free Survival | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions. |
| Secondary | Objective Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions. |
| Secondary | Duration of Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date. |
| Secondary | Time to Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response. |
| Secondary | Time to Treatment Failure | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment. |
| Secondary | Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect. |
| Secondary | Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS) | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale. |
| Secondary | Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more). |
| Secondary | Change From Baseline in NCCN FCSI Physical Well-being Scale Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm. | months | MEDIAN |
| SECONDARY | Progression-free Survival | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Primary analysis set | months | MEDIAN |
| SECONDARY | Objective Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Tumor Response Analysis Set: Participants in the primary analysis set with at least 1 Baseline unidimensionally measurable lesion per RECIST version 1.1. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Participants with an objective response | months | MEDIAN |
| SECONDARY | Time to Response | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Participants with an objective response | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks. | Primary analysis set | months | MEDIAN |
| SECONDARY | Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS) | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set participants with available data | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set participants with available data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in NCCN FCSI Physical Well-being Scale Score | From Study Day 1 through the last day of treatment or disease progression, up to Week 85. | Patient reported outcomes (PRO) analysis set participants with available data. | scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Cetuximab | 10.0 | 95% Confidence Interval 9.3 to 11.0 | months | |
| Overall Survival | Panitumumab | 10.4 | 95% Confidence Interval 9.4 to 11.6 | months | |
| Progression-free Survival | Cetuximab | 4.4 | 95% Confidence Interval 3.2 to 4.8 | months | |
| Progression-free Survival | Panitumumab | 4.1 | 95% Confidence Interval 3.2 to 4.8 | months | |
| Objective Response | Cetuximab | 19.79 | 95% Confidence Interval 16.34 to 23.62 | percentage of participants | |
| Objective Response | Panitumumab | 22.02 | 95% Confidence Interval 18.41 to 25.97 | percentage of participants | |
| Duration of Response | Cetuximab | 5.4 | 95% Confidence Interval 3.8 to 5.5 | months | |
| Duration of Response | Panitumumab | 3.8 | 95% Confidence Interval 3.7 to 4.8 | months | |
| Time to Response | Cetuximab | 2.6 | Inter-Quartile Range 1.2 to 3.1 | months | |
| Time to Response | Panitumumab | 1.5 | Inter-Quartile Range 1.2 to 3.0 | months |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab | 504 | |
| Overall Study | STARTED | Panitumumab | 506 | |
| Overall Study | Received Treatment | Cetuximab | 500 | |
| Overall Study | Received Treatment | Panitumumab | 499 | |
| Overall Study | COMPLETED | Cetuximab | 78 | |
| Overall Study | COMPLETED | Panitumumab | 85 | |
| Overall Study | NOT COMPLETED | Cetuximab | 426 | |
| Overall Study | NOT COMPLETED | Panitumumab | 421 |
Source ClinicalTrials.gov
Adverse events530
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 | Cetuximab | 30 | 503 | |
| other | Anaemia | Blood and lymphatic system disorders | Panitumumab | 29 | 496 | |
| other | Abdominal pain | Gastrointestinal disorders | Cetuximab | 74 | 503 | |
| other | Abdominal pain | Gastrointestinal disorders | Panitumumab | 52 | 496 | |
| other | Constipation | Gastrointestinal disorders | Cetuximab | 70 | 503 | |
| other | Constipation | Gastrointestinal disorders | Panitumumab | 39 | 496 | |
| other | Diarrhoea | Gastrointestinal disorders | Cetuximab | 87 | 503 | |
| other | Diarrhoea | Gastrointestinal disorders | Panitumumab | 88 | 496 | |
| other | Dyspepsia | Gastrointestinal disorders | Cetuximab | 26 | 503 | |
| other | Dyspepsia | Gastrointestinal disorders | Panitumumab | 19 | 496 |
1 to 10 of 530Source ClinicalTrials.gov
See all 530 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab | ||
| Total, all-cause mortality | Panitumumab | ||
| Total, other adverse events | Cetuximab | 474 | 503 |
| Total, other adverse events | Panitumumab | 459 | 496 |
| Total, serious adverse events | Cetuximab | 169 | 503 |
| Total, serious adverse events | Panitumumab | 151 | 496 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Cetuximab vs Panitumumab: 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.
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