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Completed

NCT Number: NCT01853319

Regorafenib in Subjects 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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ankara, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regorafenib (Stivarga, BAY73- 4506)

Drug

160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: REGARD

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
May 15, 2013
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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