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

NCT02287025 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-10-19

Study results available
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Summary

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.

Conditions

  • Physician Education

Interventions

DRUG

Regorafenib (Stivarga, BAY73-4506)

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

OTHER

iPAD application

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

OTHER

Bayer specialist

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-11
Primary Completion
2016-02-26
Completion
2016-04-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287025 on ClinicalTrials.gov