Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy

NCT ID: NCT01959269

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-07-07

Brief Summary

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The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.

Detailed Description

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Conditions

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Colorectal Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Regorafenib

Patients treated with Stivarga as 3rd or 4th line treatment, no intervention

Regorafenib (Stivarga, BAY 73-4506)

Intervention Type DRUG

As determined by the treating physician

Interventions

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Regorafenib (Stivarga, BAY 73-4506)

As determined by the treating physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients ≥ 18 years of age with metastatic CRC for whom the decision has been taken by the investigator to treat with Stivarga.
* Patients must have signed an informed consent form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SV1313

Identifier Type: OTHER

Identifier Source: secondary_id

16665

Identifier Type: -

Identifier Source: org_study_id

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