Trial · NCT02287025

A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?

NCT02287025, Phase 4, Terminated, Bayer; results first posted 2017-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes? Trials, record NCT02287025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02287025

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?
NCT number: NCT02287025
Status: Terminated
Phases: Phase 4
Enrollment: 23 participants, actual
Lead sponsor: Bayer
Conditions: Physician Education
Interventions: Regorafenib (Stivarga, BAY73-4506), iPAD application, Bayer specialist
First posted: 2014-11-10
Last updated: 2017-10-19
Results first posted: 2017-10-19
Limitations and caveats: The study was terminated prematurely due to slow recruitment (23/300 subjects enrolled). No statistical analyses of efficacy parameters were performed.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death	Up to 1 year
Secondary	Duration of Treatment	Up to 1 year
Secondary	Dose Intensity as Percentage of Planned Dose	Up to 1 year	Dose level 0 (standard starting dose) @ 160mg po qd. Dose level - 1 @ 120 mg po qd. Dose level - 2 @ 80 mg po qd. This schedule reflects the FDA-approved dosing specified in the prescribing information.
Secondary	Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension	Up to 1 year	Documented during visits as part of the interval history. All AEs will be reported in the CRF with a diagnosis, start/stop dates, action taken.
Secondary	Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire	Up to 1 year	Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.
Secondary	Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire	Up to 1 year	Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population
PRIMARY	Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death	Up to 1 year	The study was pre-maturely terminated. No data were collected from participants for this assessment.
SECONDARY	Duration of Treatment	Up to 1 year	The study was pre-maturely terminated. No data were collected from participants for this assessment.
SECONDARY	Dose Intensity as Percentage of Planned Dose	Up to 1 year	The study was pre-maturely terminated. No data were collected from participants for this assessment.
SECONDARY	Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension	Up to 1 year	The study was pre-maturely terminated. No data were collected from participants for this assessment.
SECONDARY	Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire	Up to 1 year	The study was pre-maturely terminated. No data were collected from participants for this assessment.
SECONDARY	Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire	Up to 1 year	The study was pre-maturely terminated. No data were collected from participants for this assessment.

Source ClinicalTrials.gov

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	SMART	12	6
Overall Study	STARTED	Standard of Care	11	4
Overall Study	COMPLETED	SMART	2	6
Overall Study	COMPLETED	Standard of Care	2	4
Overall Study	NOT COMPLETED	SMART	10	0
Overall Study	NOT COMPLETED	Standard of Care	9	0

Source ClinicalTrials.gov

Adverse events105

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 (Stivarga, BAY 73-4506)	1	19	1
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Regorafenib (Stivarga, BAY 73-4506)	2	19	5
other	HYPOTHYROIDISM	Endocrine disorders	Regorafenib (Stivarga, BAY 73-4506)	1	19	1
other	BLURRED VISION	Eye disorders	Regorafenib (Stivarga, BAY 73-4506)	1	19	2
other	CONJUNCTIVITIS	Eye disorders	Regorafenib (Stivarga, BAY 73-4506)	1	19	1
other	ABDOMINAL PAIN	Gastrointestinal disorders	Regorafenib (Stivarga, BAY 73-4506)	6	19	7
other	CONSTIPATION	Gastrointestinal disorders	Regorafenib (Stivarga, BAY 73-4506)	7	19	8
other	DIARRHEA	Gastrointestinal disorders	Regorafenib (Stivarga, BAY 73-4506)	9	19	21
other	DRY MOUTH	Gastrointestinal disorders	Regorafenib (Stivarga, BAY 73-4506)	2	19	2
other	DYSPHAGIA	Gastrointestinal disorders	Regorafenib (Stivarga, BAY 73-4506)	1	19	1

1 to 10 of 105Source ClinicalTrials.gov

See all 105 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regorafenib (Stivarga, BAY 73-4506)
Total, other adverse events	Regorafenib (Stivarga, BAY 73-4506)	18	19
Total, serious adverse events	Regorafenib (Stivarga, BAY 73-4506)	3	19

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02287025

GET https://conductscience.org/api/trials/v1/NCT02287025/events?page=2

API reference For AI assistants