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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Regorafenib (Stivarga, BAY73- 4506)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Regorafenib, Metastatic colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regorafenib

Arm Description

Regorafenib, 40 mg tablets

Outcomes

Primary Outcome Measures

Number of participants with adverse events as a measure of safety and tolerability
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
Number of death
Number of participants with serious adverse events as a measure of safety and tolerability
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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2013
Last Updated
April 19, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01853319
Brief Title
Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
Acronym
REGARD
Official Title
An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 24, 2013 (Actual)
Primary Completion Date
April 24, 2015 (Actual)
Study Completion Date
June 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Regorafenib, Metastatic colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regorafenib
Arm Type
Experimental
Arm Description
Regorafenib, 40 mg tablets
Intervention Type
Drug
Intervention Name(s)
Regorafenib (Stivarga, BAY73- 4506)
Intervention Description
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 Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
Up to 6 months
Title
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
Time Frame
Up to 6 months
Title
Number of death
Time Frame
Up to 6 months
Title
Number of participants with serious adverse events as a measure of safety and tolerability
Time Frame
Up to 6 months
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
City
Antalya
Country
Turkey
City
Balcali/Adana
ZIP/Postal Code
01330
Country
Turkey
City
Bursa
Country
Turkey
City
Gaziantep
ZIP/Postal Code
27010
Country
Turkey
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Kayseri
Country
Turkey
City
Samsun
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
32220908
Citation
Dane F, Ozgurdal K, Yalcin S, Benekli M, Aykan NF, Yucel I, Ozkan M, Evrensel T, Sevinc A, Coskun HS, 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.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products.

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

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