check_circleStudy Completed

Colorectal Neoplasms

Regorafenib in subjects with antiangiogenic-naive and chemotherapy-refractory advanced colorectal cancer

Trial purpose

To determine the efficacy (as measured by progression-free survival [PFS] rate at 8 weeks) of regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is refractory to standard therapies and who were never exposed to antiangiogenic therapy.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
59
Trial Dates
July 2015 - December 2017
Phase
Phase 2
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
São Paulo, 01246000, Brazil

Primary Outcome

  • Percentage of participants without disease progression or death at the end of 8 weeks
    date_rangeTime Frame:
    At week 8
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    Safety Issue:
    No

Secondary Outcome

  • Progression-Free Survival (PFS)
    PFS is defined as the date from the first dose of regorafenib until radiologic and/or clear clinical progression or death from any cause, whichever comes first.
    date_rangeTime Frame:
    Approximately 2 months
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    Safety Issue:
    No
  • Overall Survival (OS)
    OS is defined as the date from the first dose of regorafenib until death by any cause.
    date_rangeTime Frame:
    Approximately 2 months
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    Safety Issue:
    No
  • Overall Response Rate (ORR)
    ORR is defined as the proportion of subjects with the best tumor response (confirmed PR or CR) that is achieved during or within 30 days after therapy.
    date_rangeTime Frame:
    Approximately 2 months
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    Safety Issue:
    No
  • Disease Control Rate (DCR)
    DCR is defined as the proportion of subjects who have a best response rating over the whole duration of the study of CR, PR, or SD.
    date_rangeTime Frame:
    Approximately 2 months
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    Safety Issue:
    No
  • Metabolic response measured by [18F] fluorodeoxyglucose positron emission tomography (FDG PET)
    date_rangeTime Frame:
    Approximately 2 months
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    Safety Issue:
    No
  • Percentage of participants with grade 1 or higher adverse events, using NCI Common Terminology Criteria for Adverse Events (CTC-AE) Version 4.03
    date_rangeTime Frame:
    Approximately 2 months
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    Safety Issue:
    Yes

Trial design

An uncontrolled, open-label phase IIb trial of regorafenib in subjects with antiangiogenic-naive and chemotherapy-refractory advanced colorectal cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1