Trial · NCT01271712
Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)
NCT01271712, Phase 3, Completed, Bayer; results first posted 2013-10-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST). Trials, record NCT01271712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01271712
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)
- NCT number
- NCT01271712
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 199 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- Regorafenib (Stivarga, BAY73-4506), Placebo, Best supportive care
- First posted
- 2011-01-07
- Last updated
- 2021-01-29
- Other registries' IDs
- eudract:2009-017957-37
- Results first posted
- 2013-10-25
- Limitations and caveats
- Overall survival results are confounded by the fact that 85% of the participants initially randomized to placebo switched to open-label regorafenib.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year) | Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation. |
| Secondary | Overall Survival | From randomization of the first subject until date of database cutoff (08 Jun 2015) | Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Median OS was not observed at the time of PFS analysis and first analysis of OS, therefore only the proportion of death events was reported in the results posting system. This approach was maintained for the subsequent updates in the results posting system. |
| Secondary | Time to Progression (TTP) | From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year | Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST \[Response Evaluation Criteria in Solid Tumors\] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation. |
| Secondary | Tumor Response | From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year | Tumor Response of a subject was defined as the best tumor response (Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\], Partial Response \[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], Stable Disease \[SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], or Progressive Disease \[PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.\]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation. |
| Secondary | Objective Response Rate | From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year. | Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (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 non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation. |
| Secondary | Disease Control Rate (DCR) | From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year | Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (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 non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation. |
| Secondary | Duration of Response (DOR) | From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year | Duration of Response was defined as the time from date of first response (Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\] or Partial Response \[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. Results are based on central evaluation. |
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 | Progression-free Survival | From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year) | Full Analysis Set (FAS) - defined as all randomized participants. | Days | MEDIAN |
| SECONDARY | Overall Survival | From randomization of the first subject until date of database cutoff (08 Jun 2015) | Full Analysis Set (FAS). 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015 | Percentage of patients with death | NUMBER |
| SECONDARY | Time to Progression (TTP) | From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year | Full Analysis Set (FAS) | Days | MEDIAN |
| SECONDARY | Tumor Response | From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year | Full Analysis Set (FAS) | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate | From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year. | Full Analysis Set (FAS) | Percentage of Participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year | Full Analysis Set (FAS) | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year | Full Analysis Set with response participants | Days | MEDIAN |
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 |
|---|---|---|---|---|---|
| Progression-free Survival | Regorafenib (Stivarga, BAY73-4506) | 147 | 95% Confidence Interval 122 to 173 | Days | |
| Progression-free Survival | Placebo | 28 | 95% Confidence Interval 28 to 32 | Days | |
| Overall Survival | Regorafenib (Stivarga, BAY73-4506) | 82.0 | Percentage of patients with death | ||
| Overall Survival | Placebo | 80.3 | Percentage of patients with death | ||
| Time to Progression (TTP) | Regorafenib (Stivarga, BAY73-4506) | 165 | 95% Confidence Interval 125 to 174 | Days | |
| Time to Progression (TTP) | Placebo | 28 | 95% Confidence Interval 28 to 34 | Days | |
| Tumor Response | Regorafenib (Stivarga, BAY73-4506) | Complete Response (CR) | 0 | 95% Confidence Interval 0 to 0 | Percentage of Participants |
| Tumor Response | Placebo | Complete Response (CR) | 0 | 95% Confidence Interval 0 to 0 | Percentage of Participants |
| Tumor Response | Regorafenib (Stivarga, BAY73-4506) | Partial Response (PR) | 4.5 | 95% Confidence Interval 1.7 to 9.6 | Percentage of Participants |
| Tumor Response | Placebo | Partial Response (PR) | 1.5 | 95% Confidence Interval 0 to 8.2 | Percentage of Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow26
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Treatment | STARTED | Regorafenib (Stivarga, BAY73-4506) | 133 | |
| Double Blind Treatment | STARTED | Placebo First, Then Option of Open Label Regorafenib Treatment | 66 | |
| Double Blind Treatment | Participants Received Treatment | Regorafenib (Stivarga, BAY73-4506) | 132 | |
| Double Blind Treatment | Participants Received Treatment | Placebo First, Then Option of Open Label Regorafenib Treatment | 66 | |
| Double Blind Treatment | COMPLETED | Regorafenib (Stivarga, BAY73-4506) | 91 | |
| Double Blind Treatment | COMPLETED | Placebo First, Then Option of Open Label Regorafenib Treatment | 58 | |
| Double Blind Treatment | NOT COMPLETED | Regorafenib (Stivarga, BAY73-4506) | 42 | |
| Double Blind Treatment | NOT COMPLETED | Placebo First, Then Option of Open Label Regorafenib Treatment | 8 | |
| Open Label Treatment | STARTED | Regorafenib (Stivarga, BAY73-4506) | 91 | |
| Open Label Treatment | STARTED | Placebo First, Then Option of Open Label Regorafenib Treatment | 58 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 participant flowAdverse events1,050
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 | Hearing impaired | Ear and labyrinth disorders | Regorafenib (Double Blind Only) | 1 | 41 | 1 |
| other | Hearing impaired | Ear and labyrinth disorders | Placebo (Double Blind Only) | 0 | 8 | 0 |
| other | Hearing impaired | Ear and labyrinth disorders | Placebo, Open Label Only (Switch to Regorafenib) | 1 | 58 | 1 |
| other | Hearing impaired | Ear and labyrinth disorders | Treated With Regorafenib at Any Time | 7 | 190 | 7 |
| other | Hearing impaired | Ear and labyrinth disorders | Treated With Regorafenib for > 1 Year | 5 | 75 | 5 |
| other | Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Regorafenib (Double Blind Only) | 0 | 41 | 0 |
| other | Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Placebo (Double Blind Only) | 0 | 8 | 0 |
| other | Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Placebo, Open Label Only (Switch to Regorafenib) | 4 | 58 | 4 |
| other | Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Treated With Regorafenib at Any Time | 7 | 190 | 7 |
| other | Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Treated With Regorafenib for > 1 Year | 4 | 75 | 4 |
1 to 10 of 1,050Source ClinicalTrials.gov
See all 1,050 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib (Double Blind Only) | 40 | 41 |
| Total, all-cause mortality | Placebo (Double Blind Only) | 7 | 8 |
| Total, all-cause mortality | Placebo, Open Label Only (Switch to Regorafenib) | 47 | 58 |
| Total, all-cause mortality | Treated With Regorafenib at Any Time | 155 | 190 |
| Total, all-cause mortality | Treated With Regorafenib for > 1 Year | 48 | 75 |
| Total, other adverse events | Regorafenib (Double Blind Only) | 40 | 41 |
| Total, other adverse events | Placebo (Double Blind Only) | 7 | 8 |
| Total, other adverse events | Placebo, Open Label Only (Switch to Regorafenib) | 58 | 58 |
| Total, other adverse events | Treated With Regorafenib at Any Time | 189 | 190 |
| Total, other adverse events | Treated With Regorafenib for > 1 Year | 75 | 75 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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/NCT01271712
GET https://conductscience.org/api/trials/v1/NCT01271712/results?page=2