check_circleStudy Completed

Colorectal Neoplasms

Bayer Identifier:

16754

ClinicalTrials.gov Identifier:

NCT01853319

EudraCT Number:

Not Available

EU CT Number:

Not Available
Regorafenib in subjects with metastatic colorectal cancer (mCRC) who have progressed after standard therapy

Trial purpose

This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Male or female subjects >/= 18 years of age
    - Life expectancy of at least 3 months
    - Histological or cytological documentation of adenocarcinoma of the colon or rectum
    - Subjects with metastatic colorectal cancer (Stage IV)
    - Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if KRAS WT (WT: wild-type i.e. no KRAS mutation)
    - Eastern Cooperative Oncology Group (ECOG) Performance Status of - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements
    - Women of childbearing potential and men must agree to use adequate contraception since signing of the inform consent (IC) form until at least 3 months after the last study drug administration
  • - Prior treatment with regorafenib
    - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
    - Pregnant or breast-feeding subjects
    - Congestive heart failure >/= New York Heart Association (NYHA) class 2
    - Myocardial infarction less than 6 months before start of study drug
    - Ongoing infection > Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
    - Renal failure requiring hemo-or peritoneal dialysis

Trial summary

Enrollment Goal
100
Trial Dates
July 2013 - June 2018
Phase
Phase 3
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
ISTANBUL, 34899, Turkey
Completed
Istanbul, 34093, Turkey
Completed
Ankara, 06500, Turkey
Completed
Ankara, 06100, Turkey
Completed
Bursa, Turkey
Completed
Kayseri, Turkey
Completed
Balcali/Adana, 01330, Turkey
Completed
Gaziantep, 27010, Turkey
Completed
Izmir, 35100, Turkey
Completed
Samsun, Turkey
Completed
Antalya, Turkey

Primary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of death
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Progression-Free Survival (PFS)
    The PFS is defined as the time from date of treatment assignment (i.e., date of first treatment) to date of first observed disease progression or death due to any cause, if death occurs while the subject is in the study (that is, by the last visit including during the safety follow-up visit date), and before progression is observed.
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after standard therapy
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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