NCT01959269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

October 31, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2017

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

3.4 years

First QC Date

October 8, 2013

Last Update Submit

March 7, 2018

Conditions

Colorectal Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    after 40 months

Secondary Outcomes (6)

  • Progression-free survival

    after 40 months

  • Time to progression

    after 40 months

  • Disease control rate (DCR)

    after 40 months

  • Duration of Stivarga treatment

    after 40 months

  • Tumor status at different visits

    after 40 months

  • +1 more secondary outcomes

Study Arms (1)

Regorafenib

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

Drug: Regorafenib (Stivarga, BAY 73-4506)

Interventions

Regorafenib (Stivarga, BAY 73-4506)DRUG

As determined by the treating physician

Regorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female and male patients ≥ 18 years of age with a diagnosis of metastatic colorectal carcinoma (mCRC) will be enrolled in the sites during the enrollment period. All treatment decisions prior inclusion of a patient as well as during the observation must be made by the investigator based on his regular medical practice. Patients must give written informed consent prior to documentation.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 9, 2013

Study Start

October 31, 2013

Primary Completion

March 31, 2017

Study Completion

July 7, 2017

Last Updated

March 8, 2018

Record last verified: 2018-03

Locations

DE(1)