Trial · NCT04117945
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
NCT04117945, Phase 2, Unknown, Academic and Community Cancer Research United; results first posted 2024-09-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer. Trials, record NCT04117945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04117945
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
- NCT number
- NCT04117945
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
BRAF V600E Negative, KRAS Gene Mutation Negative, Locally Advanced Unresectable Colorectal Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, NRAS Gene Mutation Negative, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8
- Interventions
- Cetuximab, Irinotecan, Panitumumab, Regorafenib
- First posted
- 2019-10-07
- Last updated
- 2024-09-27
- Results first posted
- 2024-09-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 20 months | The median OS and 95% confidence intervals in each arm will be reported. |
| Secondary | First Progression-free Survival (PFS) | 11 months | The median first PFS and 95% confidence intervals in each arm will be reported. |
| Secondary | Second PFS | 3 months | The median second PFS and 95% confidence intervals in each arm will be reported. |
| Secondary | Sequential Treatment PFS | 12 months | The median PFS while on sequential treatment and 95% confidence intervals in each arm will be reported. |
| Secondary | Objective Response Rate | 20 months | Point estimates and the corresponding 95% confidence intervals for the true success proportions in each arm will be reported. |
| Secondary | Sequential Treatment Objective Response Rate | 20 months | Point estimates and the corresponding 95% confidence intervals for the true success proportions will be reported. |
| Secondary | Number of Patients Experiencing Adverse Events | 20 months | The number of patients who experience a grade 3 or higher adverse event (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 5.0), regardless of attribution, will be reported by arm. |
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 | Overall Survival (OS) | 20 months | Only eligible patients were included in analysis | months | MEDIAN |
| SECONDARY | First Progression-free Survival (PFS) | 11 months | Only eligible patients were included in analysis | months | MEDIAN |
| SECONDARY | Second PFS | 3 months | Only patients that were eligible and experienced at least one progression were included in this analysis | months | MEDIAN |
| SECONDARY | Sequential Treatment PFS | 12 months | Only eligible patients were included in analysis | months | MEDIAN |
| SECONDARY | Objective Response Rate | 20 months | Only eligible patients were included in analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sequential Treatment Objective Response Rate | 20 months | Only patients that started sequential treatment were included in this analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Experiencing Adverse Events | 20 months | Only eligible patients were included in analysis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Arm A (Regorafenib) | 3.6 | 95% Confidence Interval 0.7 to NA | months | |
| Overall Survival (OS) | Arm B (Cetuximab, Panitumumab, Irinotecan) | 13.3 | 95% Confidence Interval 7.9 to NA | months | |
| First Progression-free Survival (PFS) | Arm A (Regorafenib) | 1.2 | 95% Confidence Interval 0.7 to NA | months | |
| First Progression-free Survival (PFS) | Arm B (Cetuximab, Panitumumab, Irinotecan) | 7.0 | 95% Confidence Interval 3.9 to NA | months | |
| Second PFS | Arm A (Regorafenib) | 2.3 | 95% Confidence Interval NA to NA | months | |
| Second PFS | Arm B (Cetuximab, Panitumumab, Irinotecan) | 1.8 | 95% Confidence Interval 1.8 to NA | months | |
| Sequential Treatment PFS | Arm A (Regorafenib) | 3.6 | 95% Confidence Interval 0.7 to NA | months | |
| Sequential Treatment PFS | Arm B (Cetuximab, Panitumumab, Irinotecan) | 8.9 | 95% Confidence Interval 5.9 to NA | months | |
| Objective Response Rate | Arm A (Regorafenib) | 0 | Participants | ||
| Objective Response Rate | Arm B (Cetuximab, Panitumumab, Irinotecan) | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Regorafenib) | 12 | |
| Overall Study | STARTED | Arm B (Cetuximab, Panitumumab, Irinotecan) | 10 | |
| Overall Study | Crossed Over to Other Treatment | Arm A (Regorafenib) | 4 | |
| Overall Study | Crossed Over to Other Treatment | Arm B (Cetuximab, Panitumumab, Irinotecan) | 8 | |
| Overall Study | COMPLETED | Arm A (Regorafenib) | 0 | |
| Overall Study | COMPLETED | Arm B (Cetuximab, Panitumumab, Irinotecan) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Regorafenib) | 12 | |
| Overall Study | NOT COMPLETED | Arm B (Cetuximab, Panitumumab, Irinotecan) | 10 |
Source ClinicalTrials.gov
Adverse events416
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 | Anemia | Blood and lymphatic system disorders | Arm A (Regorafenib) | 1 | 12 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Cetuximab, Panitumumab, Irinotecan) | 5 | 10 | 13 |
| other | Anemia | Blood and lymphatic system disorders | Crossover From Arm A | 3 | 4 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Crossover From Arm B | 3 | 8 | 3 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm A (Regorafenib) | 1 | 12 | 1 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Arm B (Cetuximab, Panitumumab, Irinotecan) | 0 | 10 | 0 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Crossover From Arm A | 1 | 4 | 1 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Crossover From Arm B | 0 | 8 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm A (Regorafenib) | 1 | 12 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm B (Cetuximab, Panitumumab, Irinotecan) | 0 | 10 | 0 |
1 to 10 of 416Source ClinicalTrials.gov
See all 416 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Regorafenib) | 4 | 12 |
| Total, all-cause mortality | Arm B (Cetuximab, Panitumumab, Irinotecan) | 6 | 10 |
| Total, all-cause mortality | Crossover From Arm A | 2 | 4 |
| Total, all-cause mortality | Crossover From Arm B | 6 | 8 |
| Total, other adverse events | Arm A (Regorafenib) | 12 | 12 |
| Total, other adverse events | Arm B (Cetuximab, Panitumumab, Irinotecan) | 9 | 10 |
| Total, other adverse events | Crossover From Arm A | 4 | 4 |
| Total, other adverse events | Crossover From Arm B | 7 | 8 |
| Total, serious adverse events | Arm A (Regorafenib) | 6 | 12 |
| Total, serious adverse events | Arm B (Cetuximab, Panitumumab, Irinotecan) | 4 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Regorafenib) vs Arm B (Cetuximab, Panitumumab, Irinotecan): Sequential Treatment Objective Response Rate | Trial comparisons |
| Arm A (Regorafenib) vs Arm B (Cetuximab, Panitumumab, Irinotecan): Objective Response Rate | Trial comparisons |
| Arm A (Regorafenib) vs Arm B (Cetuximab, Panitumumab, Irinotecan): Number of Patients Experiencing 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/NCT04117945
GET https://conductscience.org/api/trials/v1/NCT04117945/events?page=2