Clinical trial NCT01853319: Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Keywords: Regorafenib
Metastatic colorectal cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 6 months
measure: Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
timeFrame: Up to 6 months
measure: Number of death
timeFrame: Up to 6 months
measure: Number of participants with serious adverse events as a measure of safety and tolerability
timeFrame: Up to 6 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Balcali/Adana
country: Turkey
city: Bursa
country: Turkey
city: Gaziantep
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Samsun
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.