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

An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Drug: Regorafenib (Stivarga, BAY73- 4506)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as a measure of safety and tolerability		Up to 6 months
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation		Up to 6 months
Number of death		Up to 6 months
Number of participants with serious adverse events as a measure of safety and tolerability		Up to 6 months
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.	Up to 6 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2013
• Primary Completion (Actual): April 24, 2015
• Study Completion (Actual): June 11, 2018

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: May 10, 2013
• First Posted (Estimate): May 15, 2013

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Regorafenib; Metastatic colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 16754

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No