Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Investigators were supported with enhanced drug-specific information via an iPad application (SMART).

Investigators were supported with standard prescribing information.

Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off

Regorafenib (Stivarga, BAY73-4506)

iPAD application

The treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise.

Bayer specialist

Bayer Study Director

Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff) support and education on treatment discontinuation rates in the absence of progression in patients with metastatic colorectal cancer treated with regorafenib. Intensified education and support will be provided through an application for iPad which has automatic links to grading, dose reduction and side effect management ,as well as, references for additional articles.

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

Does Physician Education Influence Side Effect Management and Does it Increase Time on Treatment in the Absence of Progression ? A Phase 4 Open-label Trial With Regorafenib in Metastatic Colorectal Cancer

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.

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.

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.

Bayer

SAF (N= 19) included all subjects who received at least one dose of the study medication.

Regorafenib (Stivarga, BAY 73-4506)

Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with enhanced drug-specific information via an iPad application (SMART).

SMART

Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with standard prescribing information.

Standard of Care

Total

Age, Continuous

Sex: Female, Male

The study was terminated prematurely due to slow recruitment (23/300 subjects enrolled). No statistical analyses of efficacy parameters were performed.

Therapeutic Area Head

The study was pre-maturely terminated. No data were collected from participants for this assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?	NCT02287025	Physician Educa...	Regorafenib (St... iPAD applicatio... Bayer specialis...	18 Years -	Bayer
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?	NCT02287025	Physician Educa...	Regorafenib (St... iPAD applicatio... Bayer specialis...	18 Years -	Bayer
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?	NCT02287025	Physician Educa...	Regorafenib (St... iPAD applicatio... Bayer specialis...	18 Years -	Bayer

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