Trial · NCT02394795
Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC
NCT02394795, Phase 3, Completed, Takeda; results first posted 2023-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC. Trials, record NCT02394795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02394795
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC
- NCT number
- NCT02394795
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 823 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Colorectal Cancer
- Interventions
- oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab, oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
- First posted
- 2015-03-20
- Last updated
- 2023-11-01
- Results first posted
- 2023-11-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | OS in Participants With Left-sided Tumors | Up to approximately 60 months | OS was measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. |
| Primary | Overall Survival (OS) in All Participants | Up to approximately 60 months | OS was measured as the time from the date of randomization to the date of death due to any cause. |
| Secondary | Progression-Free Survival (PFS) in Participants With Left-sided Tumors | Up to approximately 60 months | PFS was defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. |
| Secondary | Progression-Free Survival (PFS) in All Participants | Up to approximately 60 months | PFS was defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause. |
| Secondary | Response Rate (RR) in All Participants | Up to approximately 60 months | RR was defined as number of participants who achieve Complete Response (CR) and Partial Response (PR) as the best overall response per RECIST version 1.1.The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). |
| Secondary | Duration of Response (DOR) | Up to approximately 60 months | DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier. |
| Secondary | Number of Participants Treated With Curative Surgical Resection After Chemotherapy | Up to approximately 60 months | Curative surgical resection was defined as complete resection. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Up to approximately 60 months | Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred in the treatment period after receiving the protocol treatment. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | OS in Participants With Left-sided Tumors | Up to approximately 60 months | Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. The number analyzed is the number of participants with data available for analysis. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in All Participants | Up to approximately 60 months | Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in Participants With Left-sided Tumors | Up to approximately 60 months | Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. The number analyzed is the number of participants with data available for analysis. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in All Participants | Up to approximately 60 months | Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. | Months | MEDIAN |
| SECONDARY | Response Rate (RR) in All Participants | Up to approximately 60 months | Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. The number analyzed is the number of participants with data available for analysis. RR was assessed in participants with evaluable lesions at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Up to approximately 60 months | Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. The number analyzed is the number of participants with data available for analysis. DOR was evaluated in participants with complete or partial response. | Months | MEDIAN |
| SECONDARY | Number of Participants Treated With Curative Surgical Resection After Chemotherapy | Up to approximately 60 months | Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without measure protocol deviation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Up to approximately 60 months | Safety analysis set (SAS): all patients who initiated the protocol treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| OS in Participants With Left-sided Tumors | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 37.85 | 95% Confidence Interval 34.10 to 42.58 | Months | |
| OS in Participants With Left-sided Tumors | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 34.30 | 95% Confidence Interval 30.92 to 40.28 | Months | |
| Overall Survival (OS) in All Participants | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 36.24 | 95% Confidence Interval 32.03 to 39.03 | Months | |
| Overall Survival (OS) in All Participants | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 31.28 | 95% Confidence Interval 29.27 to 34.10 | Months | |
| Progression-Free Survival (PFS) in Participants With Left-sided Tumors | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 13.70 | 95% Confidence Interval 12.65 to 15.34 | Months | |
| Progression-Free Survival (PFS) in Participants With Left-sided Tumors | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 13.24 | 95% Confidence Interval 11.40 to 14.49 | Months | |
| Progression-Free Survival (PFS) in All Participants | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 12.91 | 95% Confidence Interval 11.30 to 13.63 | Months | |
| Progression-Free Survival (PFS) in All Participants | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 11.99 | 95% Confidence Interval 11.30 to 13.47 | Months | |
| Response Rate (RR) in All Participants | Group P; mFOLFOX6 + Panitumumab Combination Therapy | CR | 11 | Participants | |
| Response Rate (RR) in All Participants | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | CR | 14 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 404 | |
| Overall Study | STARTED | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 407 | |
| Overall Study | COMPLETED | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 1 | |
| Overall Study | COMPLETED | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 1 | |
| Overall Study | NOT COMPLETED | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 403 | |
| Overall Study | NOT COMPLETED | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 406 |
Source ClinicalTrials.gov
Adverse events376
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 | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 37 | 404 | |
| other | Anaemia | Blood and lymphatic system disorders | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 50 | 407 | |
| other | Constipation | Gastrointestinal disorders | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 92 | 404 | |
| other | Constipation | Gastrointestinal disorders | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 105 | 407 | |
| other | Diarrhoea | Gastrointestinal disorders | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 146 | 404 | |
| other | Diarrhoea | Gastrointestinal disorders | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 135 | 407 | |
| other | Nausea | Gastrointestinal disorders | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 158 | 404 | |
| other | Nausea | Gastrointestinal disorders | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 160 | 407 | |
| other | Stomatitis | Gastrointestinal disorders | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 249 | 404 | |
| other | Stomatitis | Gastrointestinal disorders | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 165 | 407 |
1 to 10 of 376Source ClinicalTrials.gov
See all 376 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 14 | 404 |
| Total, all-cause mortality | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 9 | 407 |
| Total, other adverse events | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 399 | 404 |
| Total, other adverse events | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 392 | 407 |
| Total, serious adverse events | Group P; mFOLFOX6 + Panitumumab Combination Therapy | 115 | 404 |
| Total, serious adverse events | Group B; mFOLFOX6 + Bevacizumab Combination Therapy | 95 | 407 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group P; mFOLFOX6 + Panitumumab Combination Therapy vs Group B; mFOLFOX6 + Bevacizumab Combination Therapy: Number of Participants Treated With Curative Surgical Resection After Chemotherapy | Trial comparisons |
| Group P; mFOLFOX6 + Panitumumab Combination Therapy vs Group B; mFOLFOX6 + Bevacizumab Combination Therapy: Number of Participants With Treatment-emergent Adverse Events (TEAE) | Trial comparisons |
| Group P; mFOLFOX6 + Panitumumab Combination Therapy vs Group B; mFOLFOX6 + Bevacizumab Combination Therapy: deaths from any cause | Trial comparisons |
| Group P; mFOLFOX6 + Panitumumab Combination Therapy vs Group B; mFOLFOX6 + Bevacizumab Combination Therapy: serious adverse events | 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/NCT02394795
GET https://conductscience.org/api/trials/v1/NCT02394795/results?page=2