check_circleStudy Completed

Colorectal Neoplasm

Bayer Identifier:

16665

ClinicalTrials.gov Identifier:

NCT01959269

EudraCT Number:

Not Available

EU CT Number:

Not Available
Investigating the use of regorafenib (Stivarga®) in patients with metastatic colorectal cancer (mCRC) after failure of standard therapy

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • ´
    - 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

Trial summary

Enrollment Goal
483
Trial Dates
October 2013 - July 2017
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • Overall survival
    date_rangeTime Frame:
    after 40 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Progression-free survival
    date_rangeTime Frame:
    after 40 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression
    date_rangeTime Frame:
    after 40 months
    enhanced_encryption
    Safety Issue:
    No
  • Disease control rate (DCR)
    Disease control rate (DCR) is defined as percentage of patients, whose best response was not progressive disease (i.e. complete response, partial response or stable disease).
    date_rangeTime Frame:
    after 40 months
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Stivarga treatment
    Duration of Stivarga treatment is defined as the time interval from start of Stivarga therapy to the date of permanent discontinuation of Stivarga therapy (regardless of the reason for discontinuation)
    date_rangeTime Frame:
    after 40 months
    enhanced_encryption
    Safety Issue:
    No
  • Tumor status at different visits
    The tumor status at different visits will be evaluated according to the categories “complete response”, “partial response”, “stable disease”, “progressive disease by clinical judgment”, “progressive disease measurement proven”, “unknown” and “not applicable”. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.
    date_rangeTime Frame:
    after 40 months
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of treatment emergent adverse events (TEAE)
    Detailed information collected for each TEAE will include: a description of the event, duration, whether the TEAE was serious, relationship to Stivarga, action taken, clinical outcome. Summary tables will present the number of subjects observed with TEAEs and corresponding percentages. Additional subcategories will be based on event intensity and relationship to study drug.
    date_rangeTime Frame:
    after 18 and 40 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

RECORA- Regorafenib in patients with metastatic colorectal cancer (mCRC) after failure of standard therapy.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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