Trial · NCT01103323
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
NCT01103323, Phase 3, Completed, Bayer; results first posted 2012-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy. Trials, record NCT01103323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01103323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
- NCT number
- NCT01103323
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 760 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Regorafenib (Stivarga, BAY73-4506), Placebo, Best Supportive Care (BSC)
- First posted
- 2010-04-14
- Last updated
- 2015-06-24
- Other registries' IDs
- eudract:2009-012787-14
- Results first posted
- 2012-11-19
- Limitations and caveats
At 2nd IA, pre-specified O'Brien-Fleming-type efficacy boundary was crossed. DMC concluded OS result positive and after positive risk benefit assessment, recommended unblinding of study. OS from 2nd IA are the final formal and definitive results.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA). | Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1. |
| Secondary | Progression-free Survival (Based on Investigator's Assessment) | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. | Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented. |
| Secondary | Objective Tumor Response | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. | The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis. |
| Secondary | Disease Control | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. | Disease control was defined as the percentage of patients whose best response was not PD \[sum of lesion sizes increased at least 20% from smallest sum on study or new lesions\] (ie, CR \[tumor disappears\], PR \[sum of lesion sizes decreased at least 30% from baseline\] or SD (stable disease)). SD included if at least 6 weeks after randomization. |
| Secondary | Tumor Response | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. | A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible. |
Source ClinicalTrials.gov
Outcomes5
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 of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA). | Intent to treat (ITT) | Days | MEDIAN |
| SECONDARY | Progression-free Survival (Based on Investigator's Assessment) | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. | ITT | Days | MEDIAN |
| SECONDARY | Objective Tumor Response | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. | ITT | Percentage of participants | NUMBER |
| SECONDARY | Disease Control | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. | ITT | Percentage of participants | NUMBER |
| SECONDARY | Tumor Response | From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. | ITT | Percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Overall Survival | Regorafenib (Stivarga, BAY73-4506)+BSC | 196 | 95% Confidence Interval 178 to 222 | Days | |
| Overall Survival | Placebo+BSC | 151 | 95% Confidence Interval 134 to 177 | Days | |
| Progression-free Survival (Based on Investigator's Assessment) | Regorafenib (Stivarga, BAY73-4506)+BSC | 59 | 95% Confidence Interval 57 to 65 | Days | |
| Progression-free Survival (Based on Investigator's Assessment) | Placebo+BSC | 52 | 95% Confidence Interval 51 to 53 | Days | |
| Objective Tumor Response | Regorafenib (Stivarga, BAY73-4506)+BSC | 1.0 | Percentage of participants | ||
| Objective Tumor Response | Placebo+BSC | 0.4 | Percentage of participants | ||
| Disease Control | Regorafenib (Stivarga, BAY73-4506)+BSC | 41.0 | Percentage of participants | ||
| Disease Control | Placebo+BSC | 14.9 | Percentage of participants | ||
| Tumor Response | Regorafenib (Stivarga, BAY73-4506)+BSC | Complete Response (CR) | 0 | Percentage of participants | |
| Tumor Response | Placebo+BSC | Complete Response (CR) | 0 | Percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Without/Before Drug Switch | STARTED | Regorafenib (Stivarga, BAY73-4506)+BSC | 505 | |
| Without/Before Drug Switch | STARTED | Placebo+BSC | 255 | |
| Without/Before Drug Switch | Participants Received Treatment | Regorafenib (Stivarga, BAY73-4506)+BSC | 500 | |
| Without/Before Drug Switch | Participants Received Treatment | Placebo+BSC | 253 | |
| Without/Before Drug Switch | COMPLETED | Regorafenib (Stivarga, BAY73-4506)+BSC | 429 | |
| Without/Before Drug Switch | COMPLETED | Placebo+BSC | 237 | |
| Without/Before Drug Switch | NOT COMPLETED | Regorafenib (Stivarga, BAY73-4506)+BSC | 76 | |
| Without/Before Drug Switch | NOT COMPLETED | Placebo+BSC | 18 | |
| Switched From Placebo to Regorafenib | STARTED | Regorafenib (Stivarga, BAY73-4506)+BSC | 0 | |
| Switched From Placebo to Regorafenib | STARTED | Placebo+BSC | 4 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events630
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 | Edema: Limb | Blood and lymphatic system disorders | Regorafenib (BAY73-4506)+BSC | 49 | 500 | 57 |
| other | Edema: Limb | Blood and lymphatic system disorders | Placebo+BSC | 16 | 253 | 19 |
| other | Edema: Limb | Blood and lymphatic system disorders | Placebo - Regorafenib After Unblinding | 0 | 4 | 0 |
| other | Hemoglobin | Blood and lymphatic system disorders | Regorafenib (BAY73-4506)+BSC | 76 | 500 | 142 |
| other | Hemoglobin | Blood and lymphatic system disorders | Placebo+BSC | 29 | 253 | 46 |
| other | Hemoglobin | Blood and lymphatic system disorders | Placebo - Regorafenib After Unblinding | 0 | 4 | 0 |
| other | Platelets | Blood and lymphatic system disorders | Regorafenib (BAY73-4506)+BSC | 79 | 500 | 136 |
| other | Platelets | Blood and lymphatic system disorders | Placebo+BSC | 6 | 253 | 9 |
| other | Platelets | Blood and lymphatic system disorders | Placebo - Regorafenib After Unblinding | 1 | 4 | 2 |
| other | Hypertension | Cardiac disorders | Regorafenib (BAY73-4506)+BSC | 155 | 500 | 213 |
1 to 10 of 630Source ClinicalTrials.gov
See all 630 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib (BAY73-4506)+BSC | ||
| Total, all-cause mortality | Placebo+BSC | ||
| Total, all-cause mortality | Placebo - Regorafenib After Unblinding | ||
| Total, other adverse events | Regorafenib (BAY73-4506)+BSC | 489 | 500 |
| Total, other adverse events | Placebo+BSC | 229 | 253 |
| Total, other adverse events | Placebo - Regorafenib After Unblinding | 4 | 4 |
| Total, serious adverse events | Regorafenib (BAY73-4506)+BSC | 232 | 500 |
| Total, serious adverse events | Placebo+BSC | 103 | 253 |
| Total, serious adverse events | Placebo - Regorafenib After Unblinding | 2 | 4 |
Source ClinicalTrials.gov
Papers4
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 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/NCT01103323
GET https://conductscience.org/api/trials/v1/NCT01103323/results?page=2