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Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Regorafenib (Stivarga, BAY73-4506)
Placebo
Best Supportive Care (BSC)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum
  • Progression during or within 3 months following the last administration of approved standard therapies. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
  • Patients with measurable or non measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
  • Life expectancy of at least 3 months
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Unstable/uncontrolled cardiac disease
  • History of arterial or venous thrombotic or embolic events
  • Symptomatic metastatic brain or meningeal tumors
  • Patients with evidence or history of bleeding diathesis
  • Interstitial lung disease - Persistent proteinuria >/= grade 3
  • Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity </= Grade 2

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Regorafenib (Stivarga, BAY73-4506)+BSC

Placebo+BSC

Arm Description

Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care(BSC).

Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care (BSC).

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.

Secondary Outcome Measures

Progression-free Survival (Based on Investigator's Assessment)
Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.
Objective Tumor Response
The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.
Disease Control
Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.
Tumor Response
A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.

Full Information

First Posted
April 8, 2010
Last Updated
May 28, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01103323
Brief Title
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
Official Title
A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC
Detailed Description
All participants received Best Supportive Care. Acronyms used in Adverse events section: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE), International Normalized Ratio (INR), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Cranial nerves (CN), Disseminated Intravascular Coagulation (DIC), Cardiac troponin T (cTnT). Abbreviation used in Results section: Data Monitoring Committee (DMC). Adverse event collection will be covered in Adverse events section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
760 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regorafenib (Stivarga, BAY73-4506)+BSC
Arm Type
Experimental
Arm Description
Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care(BSC).
Arm Title
Placebo+BSC
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus Best Supportive Care (BSC).
Intervention Type
Drug
Intervention Name(s)
Regorafenib (Stivarga, BAY73-4506)
Intervention Description
160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
Intervention Type
Other
Intervention Name(s)
Best Supportive Care (BSC)
Intervention Description
BSC includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.
Time Frame
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).
Secondary Outcome Measure Information:
Title
Progression-free Survival (Based on Investigator's Assessment)
Description
Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.
Time Frame
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
Title
Objective Tumor Response
Description
The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.
Time Frame
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
Title
Disease Control
Description
Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.
Time Frame
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
Title
Tumor Response
Description
A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.
Time Frame
From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological or cytological documentation of adenocarcinoma of the colon or rectum Progression during or within 3 months following the last administration of approved standard therapies. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy Patients with measurable or non measurable disease Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1 Life expectancy of at least 3 months Adequate bone marrow, liver and renal function Exclusion Criteria: Unstable/uncontrolled cardiac disease History of arterial or venous thrombotic or embolic events Symptomatic metastatic brain or meningeal tumors Patients with evidence or history of bleeding diathesis Interstitial lung disease - Persistent proteinuria >/= grade 3 Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity </= Grade 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
St. Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9110
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1122AAL
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1264AAA
Country
Argentina
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
City
San Miguel de Tucumán
State/Province
Tucuman
ZIP/Postal Code
T4000GTB
Country
Argentina
City
Capital Federal-Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
Woolloogabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41830-492
Country
Brazil
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60160-230
Country
Brazil
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-090
Country
Brazil
City
Ijuí
State/Province
Rio Grande do Sul
ZIP/Postal Code
98700-000
Country
Brazil
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266100
Country
China
City
Beijing
ZIP/Postal Code
100021
Country
China
City
Beijing
ZIP/Postal Code
100071
Country
China
City
Changchun
ZIP/Postal Code
130021
Country
China
City
Chongqing
ZIP/Postal Code
400038
Country
China
City
Chongqing
ZIP/Postal Code
400042
Country
China
City
Fuzhou
ZIP/Postal Code
350014
Country
China
City
Fuzhou
ZIP/Postal Code
350025
Country
China
City
Ha'erbin
ZIP/Postal Code
150040
Country
China
City
Hanghzou
ZIP/Postal Code
310009
Country
China
City
Shanghai
ZIP/Postal Code
200001
Country
China
City
Shanghai
ZIP/Postal Code
200030
Country
China
City
Tianjin
ZIP/Postal Code
300060
Country
China
City
Brno
ZIP/Postal Code
65 653
Country
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Praha
ZIP/Postal Code
18081
Country
Czech Republic
City
Avignon
ZIP/Postal Code
84000
Country
France
City
Le Mans Cedex 2
ZIP/Postal Code
72015
Country
France
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
City
Marseille
ZIP/Postal Code
13005
Country
France
City
Montpellier
ZIP/Postal Code
34298
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Rennes
ZIP/Postal Code
35042
Country
France
City
Strasbourg Cedex
ZIP/Postal Code
67085
Country
France
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
Karlsruhe
State/Province
Baden-Württemberg
ZIP/Postal Code
76137
Country
Germany
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70199
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81737
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81925
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26133
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
City
Leverkusen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51375
Country
Germany
City
Porta Westfalica
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32457
Country
Germany
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39104
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Berlin
ZIP/Postal Code
13125
Country
Germany
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
City
Holon
Country
Israel
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Tel Hashomer
ZIP/Postal Code
5262000
Country
Israel
City
Zrifin
ZIP/Postal Code
6093000
Country
Israel
City
Brescia
ZIP/Postal Code
25124
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Milano
ZIP/Postal Code
20133
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Modena
ZIP/Postal Code
41124
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Pisa
ZIP/Postal Code
56126
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
City
Kita-Adachigun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
City
Sunto
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
City
Leeuwarden
ZIP/Postal Code
8901 BR
Country
Netherlands
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
City
Aveiro
ZIP/Postal Code
3810-096
Country
Portugal
City
Coimbra
ZIP/Postal Code
3030-075
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Málaga
ZIP/Postal Code
29010
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Chur
State/Province
Graubünden
ZIP/Postal Code
7000
Country
Switzerland
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
City
Instanbul
ZIP/Postal Code
34662
Country
Turkey
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
23177514
Citation
Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.
Results Reference
result
PubMed Identifier
22421192
Citation
Mross K, Frost A, Steinbild S, Hedbom S, Buchert M, Fasol U, Unger C, Kratzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.
Results Reference
result
PubMed Identifier
26184520
Citation
Tabernero J, Lenz HJ, Siena S, Sobrero A, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Yoshino T, Goldberg RM, Sargent DJ, Wagner A, Laurent D, Teufel M, Jeffers M, Grothey A, Van Cutsem E. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol. 2015 Aug;16(8):937-48. doi: 10.1016/S1470-2045(15)00138-2. Epub 2015 Jul 13.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

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