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Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy (REGARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01853319
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE May 15, 2013
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE July 24, 2013
Actual Primary Completion Date April 24, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2015)
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 6 months ]
  • Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation [ Time Frame: Up to 6 months ]
  • Number of death [ Time Frame: Up to 6 months ]
  • Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 6 months ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to 6 months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 6 months ]
  • Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation [ Time Frame: Up to 6 months ]
  • Number of death [ Time Frame: Up to 6 months ]
  • Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
Official Title  ICMJE An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Drug: Regorafenib (Stivarga, BAY73- 4506)
160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
Study Arms  ICMJE Experimental: Regorafenib
Regorafenib, 40 mg tablets
Intervention: Drug: Regorafenib (Stivarga, BAY73- 4506)
Publications * Dane F, Ozgurdal K, Yalçın Ş, Benekli M, Aykan NF, Yücel İ, Özkan M, Evrensel T, Sevinç A, Coskun HŞ, Sanli UA, Kara IO, Yumuk PF. Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study. BMJ Open. 2020 Mar 26;10(3):e027665. doi: 10.1136/bmjopen-2018-027665.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 11, 2018
Actual Primary Completion Date April 24, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 </= 1
  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01853319
Other Study ID Numbers  ICMJE 16754
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP