Trial · NCT01289821
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
NCT01289821, Phase 2, Completed, Bayer; results first posted 2013-09-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib. Trials, record NCT01289821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01289821
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
- NCT number
- NCT01289821
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Colorectal Neoplasms
- Interventions
- Regorafenib (Stivarga, BAY73-4506), Oxaliplatin, Folinic acid, 5-FU (mFOLFOX6)
- First posted
- 2011-02-04
- Last updated
- 2017-03-15
- Other registries' IDs
- eudract:2010-020121-41
- Results first posted
- 2013-09-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (OR) | From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks. | OR was defined as the best tumor response (confirmed complete response \[CR\] or partial response \[PR\]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a 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, no unequivocal progression of existing nontarget lesions and no appearance of new lesions. |
| Secondary | Overall Survival (OS) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | OS was calculated as the time from first date of receiving study treatment to date of death due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up. |
| Secondary | Progression-free Survival (PFS) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | PFS was defined as time from the date of start of study treatment to the date of first observed disease progression (radiological according to central assessment or clinical), or death due to any cause, if death occurred before progression was documented. PFS for participants without disease progression or death at the date of database cutoff were right-censored at the last date of tumor assessment. Participants who had no tumor evaluation after baseline and no clinical progression post baseline and who did not die were censored at Day 1 in the analysis. 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). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non target lesions or the appearance of one or more new lesions will also constitute PD. |
| Secondary | Disease Control (DC) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | DC was defined as the proportion of participants who had a best response rating of CR, PR, or stable disease (SD) according to RECIST criteria that was achieved during treatment or within 30 days after termination of study treatment. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. A minimum of 8 weeks (allowing a minus 7-day time window) between start of study treatment and the first follow-up tumor assessment with SD as response was required to assign SD as best overall response. |
| Secondary | Duration of Response (DOR) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | DOR was defined as the time from the date of first documented objective response of PR or CR, whichever was noted earlier, to first subsequent disease progression or death (if death occurred before progression was documented). DOR was defined for responders only (that is, subjects with CR or PR). DOR for subjects without disease progression or death before progression was right censored at the date of their last tumor assessment. |
| Secondary | Duration of Stable Disease (DOSD) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD. DOSR was defined as the time (in days) from date of start of study treatment to the date at which disease progression or death (if death occurred before progression was first documented). The date the tumor scan was performed was used for this calculation. DOSD for participants without disease progression or death before progression at the time of analysis were censored at the date of their last tumor assessment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response (OR) | From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks. | Primary analysis set (PAS, N=41) was a subset of the PPS and included the first 41 subjects, who were assigned to treatment | Proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | Full analysis set (FAS, N=54) included all subjects who received treatment. | Days | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | Full analysis set (FAS) | Days | MEDIAN |
| SECONDARY | Disease Control (DC) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | PAS | Proportion of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | Per protocol set (PPS) | Days | MEDIAN |
| SECONDARY | Duration of Stable Disease (DOSD) | From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks | Per protocol set (PPS) | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response (OR) | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 0.4390 | Proportion of participants | ||
| Overall Survival (OS) | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 772 | 95% Confidence Interval 646 to 1089 | Days | |
| Progression-free Survival (PFS) | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 258 | 95% Confidence Interval 222 to 334 | Days | |
| Disease Control (DC) | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 0.8537 | Proportion of participants | ||
| Duration of Response (DOR) | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 257 | 95% Confidence Interval 176 to 349 | Days | |
| Duration of Stable Disease (DOSD) | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 231 | 95% Confidence Interval 167 to 259 | Days |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 54 | |
| Treatment Period | Participants Received Regorafenib | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 54 | |
| Treatment Period | COMPLETED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 0 | |
| Treatment Period | NOT COMPLETED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 54 | |
| Safety Follow-up Period | STARTED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 54 | |
| Safety Follow-up Period | COMPLETED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 49 | |
| Safety Follow-up Period | NOT COMPLETED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 5 | |
| Survival Follow-up Period | STARTED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 52 | |
| Survival Follow-up Period | COMPLETED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 34 | |
| Survival Follow-up Period | NOT COMPLETED | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 18 |
Source ClinicalTrials.gov
Adverse events110
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 | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 12 | 53 | 25 |
| other | Conduction disorder | Cardiac disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 4 | 53 | 8 |
| other | Sinus bradycardia | Cardiac disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 3 | 53 | 3 |
| other | Hypothyroidism | Endocrine disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 6 | 53 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 28 | 53 | 47 |
| other | Constipation | Gastrointestinal disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 17 | 53 | 26 |
| other | Diarrhea | Gastrointestinal disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 37 | 53 | 124 |
| other | Dyspepsia | Gastrointestinal disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 6 | 53 | 7 |
| other | Mucositis oral | Gastrointestinal disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 24 | 53 | 65 |
| other | Nausea | Gastrointestinal disorders | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 28 | 53 | 70 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | ||
| Total, other adverse events | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 53 | 53 |
| Total, serious adverse events | Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6) | 25 | 53 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23493136 | RESULT |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01289821
GET https://conductscience.org/api/trials/v1/NCT01289821/events?page=2