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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

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Trial Information

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


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
- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events as a measure of safety and tolerability

Outcome Time Frame:

Up to 6 months

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Turkey: Ministry of Health Turkey General Directorate of Pharmaceuticals and Pharmacy

Study ID:

16754

NCT ID:

NCT01853319

Start Date:

July 2013

Completion Date:

July 2014

Related Keywords:

  • Colorectal Neoplasms
  • Regorafenib
  • Metastatic colorectal cancer
  • Neoplasms
  • Colorectal Neoplasms

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