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Stivarga Real Life Evidence in Hungary

NCT02656524 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2018-02-12

No results posted yet for this study

Summary

The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Regorafenib (Stivarga, BAY73-4506)

Product is used in accordance with SmPC

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2017-02-15
Completion
2017-02-15

Countries

  • Hungary

Study Locations

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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 NCT02656524 on ClinicalTrials.gov