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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

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Regorafenib (Stivarga, BAY73- 4506) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
Actual Study Start Date : July 24, 2013
Actual Primary Completion Date : April 24, 2015
Actual Study Completion Date : June 11, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: Regorafenib
Regorafenib, 40 mg tablets
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)




Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 6 months ]
  2. Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation [ Time Frame: Up to 6 months ]
  3. Number of death [ Time Frame: Up to 6 months ]
  4. Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 6 months ]
  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853319


Locations
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Turkey
Ankara, Turkey, 06100
Ankara, Turkey, 06500
Antalya, Turkey
Balcali/Adana, Turkey, 01330
Bursa, Turkey
Gaziantep, Turkey, 27010
Istanbul, Turkey, 34093
Istanbul, Turkey, 34899
Izmir, Turkey, 35100
Kayseri, Turkey
Samsun, Turkey
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01853319    
Other Study ID Numbers: 16754
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Regorafenib
Metastatic colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases