Trial · NCT02080260
A Study of Regorafenib in Advanced Pancreatic Cancer Patients
NCT02080260, Phase 2, Completed, Wake Forest University Health Sciences; results first posted 2019-07-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Regorafenib in Advanced Pancreatic Cancer Patients. Trials, record NCT02080260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02080260
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Regorafenib in Advanced Pancreatic Cancer Patients
- NCT number
- NCT02080260
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Pancreatic Cancer
- Interventions
- regorafenib
- First posted
- 2014-03-06
- Last updated
- 2022-04-21
- Results first posted
- 2019-07-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects | 16 weeks after enrollment | 16-week progression free survival was determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 16 weeks after treatment start, with progression defined radiographically using RECIST v1.1 or clinically based upon investigator assessment. |
| Secondary | Progression Free Survival | From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years. | PFS is defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diseased of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled CT assessments will be censored at date of last assessment prior to first missed assessment. |
| Secondary | Overall Survival | From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years. | Overall survival is defined as the duration from enrollment date to the date of death from any cause. Subjects who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive. |
| Secondary | Overall Response | From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks) | Overall response will be determined as the best treatment response for each patient as a binary variable indicating whether or not the patient achieved a Complete Response (CR) or Partial Response (PR) as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1):Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. For the purposes of response determination, confirmatory scan for CR and PR is not required. |
| Secondary | Disease Control | From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks) | Disease control will be determined for each patient as a binary variable indicating whether or not the patient achieved a best overall best response of CR, PR, or stable disease as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1): Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. |
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 | Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects | 16 weeks after enrollment | Efficacy analyses were conducted on the population of subjects who began regorafenib treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival | From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years. | Efficacy analyses were conducted on the population of subjects who began regorafenib treatment | weeks | MEDIAN |
| SECONDARY | Overall Survival | From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years. | Efficacy analyses were conducted on the population of subjects who began regorafenib treatment | weeks | MEDIAN |
| SECONDARY | Overall Response | From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks) | Efficacy analyses were conducted on the population of subjects who began regorafenib treatment. Analysis of overall response rate was conducted on those patients in the efficacy population with measurable disease present at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control | From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks) | Efficacy analyses were conducted on the population of subjects who began regorafenib treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects | Single Arm, Regorafenib | 2 | Participants | ||
| Progression Free Survival | Single Arm, Regorafenib | 6.1 | 95% Confidence Interval 2.9 to 7.1 | weeks | |
| Overall Survival | Single Arm, Regorafenib | 9.4 | 95% Confidence Interval 8.1 to 17.0 | weeks | |
| Overall Response | Single Arm, Regorafenib | 1 | Participants | ||
| Disease Control | Single Arm, Regorafenib | 6 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm, Regorafenib | 20 | |
| Overall Study | COMPLETED | Single Arm, Regorafenib | 1 | |
| Overall Study | NOT COMPLETED | Single Arm, Regorafenib | 19 |
Source ClinicalTrials.gov
Adverse events113
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 | Single Arm, Regorafenib | 8 | 20 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Single Arm, Regorafenib | 2 | 20 | |
| other | Sinus tachycardia | Cardiac disorders | Single Arm, Regorafenib | 1 | 20 | |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Single Arm, Regorafenib | 1 | 20 | |
| other | Hearing impaired | Ear and labyrinth disorders | Single Arm, Regorafenib | 2 | 20 | |
| other | Eye pain | Eye disorders | Single Arm, Regorafenib | 1 | 20 | |
| other | Floaters | Eye disorders | Single Arm, Regorafenib | 1 | 20 | |
| other | Abdominal distension | Gastrointestinal disorders | Single Arm, Regorafenib | 1 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Single Arm, Regorafenib | 8 | 20 | |
| other | Ascites | Gastrointestinal disorders | Single Arm, Regorafenib | 2 | 20 |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm, Regorafenib | 18 | 20 |
| Total, other adverse events | Single Arm, Regorafenib | 20 | 20 |
| Total, serious adverse events | Single Arm, Regorafenib | 13 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02080260
GET https://conductscience.org/api/trials/v1/NCT02080260/events?page=2