Trial · NCT02337946
Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Participants With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma
NCT02337946, Phase 2, Completed, Takeda; results first posted 2019-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Participants With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma. Trials, record NCT02337946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02337946
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Safety and Efficacy Study of mFOLFOX6 + Panitumumab Combination Therapy and 5-FU/LV + Panitumumab Combination Therapy in Participants With Chemotherapy-naïve Unresectable Advanced Recurrent Colorectal Carcinoma
- NCT number
- NCT02337946
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 164 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Colorectal Carcinoma
- Interventions
- oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab, oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab
- First posted
- 2015-01-14
- Last updated
- 2019-09-10
- Results first posted
- 2019-03-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival Rate (PFS Rate) at 9 Months After Randomization | Up to 9 months after randomization | PFS rate was defined as the gross percentage of participants who survived with no evidence of progression from the day of randomization (Day 0) until 9 months after Day 0. The presence/absence of progressive disease (PD) was determined based on imaging, consideration of clinical PD, or survival research results. PD based on response evaluation criteria in solid tumors (RECIST) is 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). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Progression-Free Survival (PFS) | Up to approximately 31 months | The PFS is the period from the date of randomization (Day 0) until the date of judgment of progression from the date of randomization, or until death by all causes, whichever comes first. The presence/absence of progressive disease (PD) was determined based on imaging, consideration of clinical PD, or survival research results. PD based on response evaluation criteria in solid tumors (RECIST) is 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). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Overall Survival (OS) | Up to approximately 31 months | OS was defined as the time from the day of randomization (Day 0) until death by all causes. |
| Secondary | Response Rate (RR) | Up to approximately 31 months | RR was defined as the percentage of participants who had shown complete response (CR) or partial response (PR) as the best overall response in accordance with the RECIST 1.1 criteria after randomization. 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 | Time to Treatment Failure (TTF) | Up to approximately 31 months | TTF was defined as the time from the day of randomization (Day 0) until the day of protocol treatment discontinuation determination, the day of PD decision during protocol treatment, or death from any cause, whichever came the earliest. |
| Secondary | Percentage of Participants With Adverse Events | Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date) | Safety population was defined as all participants who received at least one dose of protocol treatment after randomization. |
| Secondary | Percentage of Participants With Adverse Events by Severity Graded Using the Common Terminology Criteria for Adverse Events (CTCAE) Grade | Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
| Secondary | Percentage of Participants With Grade 2 or Higher Peripheral Neuropathy | Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date) | Peripheral neuropathy was defined as events classified with a preferred term (PT) of "peripheral neuropathy" according to Standardized MedDRA Queries. |
| Secondary | Percentage of Participants With Grade 3 or Higher Skin Toxicity | Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date) | Skin toxicity was defined as events classified with an system organ class of "Skin and subcutaneous tissue disorders" or a preferred term of "paronychia". |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival Rate (PFS Rate) at 9 Months After Randomization | Up to 9 months after randomization | Full Analysis Set (FAS) was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Up to approximately 31 months | FAS was defined as all randomized participants. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 31 months | FAS was defined as all randomized participants. | months | MEDIAN |
| SECONDARY | Response Rate (RR) | Up to approximately 31 months | FAS was defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Failure (TTF) | Up to approximately 31 months | FAS was defined as all randomized participants. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events | Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date) | Safety population was defined as all participants who received at least one dose of protocol treatment after randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events by Severity Graded Using the Common Terminology Criteria for Adverse Events (CTCAE) Grade | Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date) | Safety population was defined as all participants who received at least one dose of protocol treatment after randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Grade 2 or Higher Peripheral Neuropathy | Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date) | Safety population was defined as all participants who received at least one dose of protocol treatment after randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Grade 3 or Higher Skin Toxicity | Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date) | Safety population was defined as all participants who received at least one dose of protocol treatment after randomization. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival Rate (PFS Rate) at 9 Months After Randomization | Group A | 46.4 | 80% Confidence Interval 38.1 to 54.9 | percentage of participants | |
| Progression-Free Survival Rate (PFS Rate) at 9 Months After Randomization | Group B | 47.4 | 80% Confidence Interval 39.1 to 55.8 | percentage of participants | |
| Progression-Free Survival (PFS) | Group A | 9.1 | 95% Confidence Interval 8.6 to 11.1 | months | |
| Progression-Free Survival (PFS) | Group B | 9.3 | 95% Confidence Interval 6.0 to 13.0 | months | |
| Overall Survival (OS) | Group A | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Group B | NA | 95% Confidence Interval NA to NA | months | |
| Response Rate (RR) | Group A | 80.4 | 95% Confidence Interval 68.0 to 88.8 | percentage of participants | |
| Response Rate (RR) | Group B | 87.7 | 95% Confidence Interval 76.4 to 94.2 | percentage of participants | |
| Time to Treatment Failure (TTF) | Group A | 8.1 | 95% Confidence Interval 5.9 to 9.5 | months | |
| Time to Treatment Failure (TTF) | Group B | 6.1 | 95% Confidence Interval 4.5 to 9.3 | months |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Protocol Treatment 1 Period | STARTED | Protocol Treatment 1 | 164 | |
| Protocol Treatment 1 Period | STARTED | Protocol Treatment Period 2: Group A | 0 | |
| Protocol Treatment 1 Period | STARTED | Protocol Treatment Period 2: Group B | 0 | |
| Protocol Treatment 1 Period | COMPLETED | Protocol Treatment 1 | 114 | |
| Protocol Treatment 1 Period | COMPLETED | Protocol Treatment Period 2: Group A | 0 | |
| Protocol Treatment 1 Period | COMPLETED | Protocol Treatment Period 2: Group B | 0 | |
| Protocol Treatment 1 Period | NOT COMPLETED | Protocol Treatment 1 | 50 | |
| Protocol Treatment 1 Period | NOT COMPLETED | Protocol Treatment Period 2: Group A | 0 | |
| Protocol Treatment 1 Period | NOT COMPLETED | Protocol Treatment Period 2: Group B | 0 | |
| In-between Period | STARTED | Protocol Treatment 1 | 114 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events148
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 | Neutrophil count decreased | Investigations | Group A | 18 | 56 | 44 |
| other | Neutrophil count decreased | Investigations | Group B | 15 | 54 | 19 |
| other | White blood cell count decreased | Investigations | Group A | 7 | 56 | 12 |
| other | White blood cell count decreased | Investigations | Group B | 9 | 54 | 18 |
| other | Platelet count decreased | Investigations | Group A | 5 | 56 | 17 |
| other | Platelet count decreased | Investigations | Group B | 2 | 54 | 2 |
| other | Neuropathy peripheral | Nervous system disorders | Group A | 8 | 56 | 8 |
| other | Neuropathy peripheral | Nervous system disorders | Group B | 6 | 54 | 6 |
| other | Dysgeusia | Nervous system disorders | Group A | 7 | 56 | 7 |
| other | Dysgeusia | Nervous system disorders | Group B | 4 | 54 | 4 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | 2 | 56 |
| Total, all-cause mortality | Group B | 0 | 54 |
| Total, other adverse events | Group A | 47 | 56 |
| Total, other adverse events | Group B | 45 | 54 |
| Total, serious adverse events | Group A | 20 | 56 |
| Total, serious adverse events | Group B | 18 | 54 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A vs Group B: deaths from any cause | Trial comparisons |
| Group A vs Group B: 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/NCT02337946
GET https://conductscience.org/api/trials/v1/NCT02337946/results?page=2