check_circleStudy Completed

Metastatic Colorectal Cancer

Bayer Identifier:

14387

ClinicalTrials.gov Identifier:

NCT01103323

EudraCT Number:

2009-012787-14

EU CT Number:

Not Available
Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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 - Life expectancy of at least 3 months
    - Adequate bone marrow, liver and renal function
  • - 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

Trial summary

Enrollment Goal
760
Trial Dates
April 2010 - January 2014
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Halle, 06120, Germany
Completed
Oldenburg, 26133, Germany
Completed
Rochester, 55905, United States
Completed
LILLE CEDEX, 59037, France
Completed
LE MANS CEDEX 2, 72015, France
Withdrawn
RENNES, 35042, France
Completed
Milano, 20162, Italy
Completed
Brescia, 25124, Italy
Completed
Napoli, 80131, Italy
Completed
Sevilla, 41013, Spain
Completed
Madrid, 28041, Spain
Completed
Málaga, 29010, Spain
Completed
Madrid, 28046, Spain
Completed
LEUVEN, 3000, Belgium
Completed
Porta Westfalica, 32457, Germany
Completed
Stuttgart, 70199, Germany
Completed
München, 81377, Germany
Completed
München, 81737, Germany
Completed
Berlin, 13125, Germany
Completed
Magdeburg, 39104, Germany
Completed
München, 81925, Germany
Completed
Essen, 45122, Germany
Completed
MONTPELLIER, 34298, France
Completed
REIMS, 51092, France
Completed
PARIS, 75651, France
Completed
Centre Oscar Lambret - LilleLILLE CEDEX, 59020, France
Completed
MARSEILLE, 13005, France
Completed
Genova, 16132, Italy
Completed
ROESELARE, 8800, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
EDEGEM, 2650, Belgium
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
Praha, 18081, Czechia
Completed
Brno, 65 653, Czechia
Completed
Hradec Kralove, 500 05, Czechia
Completed
Ramat Gan, 5266202, Israel
Completed
Tel Aviv, 6423906, Israel
Withdrawn
Rehovot, 7610001, Israel
Withdrawn
Holon, 5822012, Israel
Withdrawn
Zrifin, 7030000, Israel
Completed
Concord, 2139, Australia
Withdrawn
Woolloogabba, 4102, Australia
Completed
Woodville South, 5011, Australia
Completed
Napoli, 80131, Italy
Completed
Modena, 41124, Italy
Completed
Pisa, 56126, Italy
Completed
Roma, 00168, Italy
Completed
Reggio Emilia, 42123, Italy
Withdrawn
Milano, 20133, Italy
Completed
Barcelona, 08035, Spain
Completed
Sabadell, 08208, Spain
Completed
Madrid, 28040, Spain
Completed
Hospitalet de Llobregat, 08907, Spain
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
Olomouc, 779 00, Czechia
Completed
Haifa, 3109601, Israel
Completed
Jerusalem, 9112001, Israel
Withdrawn
Porto, 4099-001, Portugal
Withdrawn
Porto, 4200-072, Portugal
Completed
Ankara, 06500, Turkey
Withdrawn
Belo Horizonte, 30110-090, Brazil
Withdrawn
Ashkelon, 7830604, Israel
Completed
Beer Sheva, 8410101, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Parkville, 3050, Australia
Completed
Footscray, 3011, Australia
Completed
St Leonards, 2065, Australia
Withdrawn
Lisboa, 1649-035, Portugal
Withdrawn
Aveiro, 3810-096, Portugal
Withdrawn
Nyiregyhaza, 4400, Hungary
Completed
Debrecen, 4032, Hungary
Withdrawn
Budapest, 1082, Hungary
Completed
Szeged, 6725, Hungary
Withdrawn
Izmir, 35100, Turkey
Completed
Istanbul, 34093, Turkey
Withdrawn
Istanbul, 34899, Turkey
Withdrawn
Fortaleza, 60160-230, Brazil
Completed
Genève, 1211, Switzerland
Withdrawn
Chur, 7000, Switzerland
Completed
Trier, 54290, Germany
Completed
Dresden, 01307, Germany
Completed
Köln, 50924, Germany
Completed
Mannheim, 68167, Germany
Completed
Hannover, 30625, Germany
Withdrawn
Karlsruhe, 76137, Germany
Withdrawn
Leverkusen, 51375, Germany
Completed
Sumter, 29150, United States
Withdrawn
Mission Hills, 91345, United States
Withdrawn
Beverly Hills, 90211, United States
Withdrawn
Orange, 92868, United States
Completed
Scranton, 18510, United States
Completed
Jefferson City, 65109, United States
Withdrawn
Neptune, 07754, United States
Withdrawn
Redlands, 92374, United States
Completed
Aventura, 33180, United States
Withdrawn
New York, 10011, United States
Completed
Los Angeles, 90033, United States
Withdrawn
New York, 10011, United States
Completed
Dallas, 75390-9110, United States
Completed
Peoria, 61615-7828, United States
Completed
New Orleans, 70121, United States
Completed
Neptune, 07754, United States
Completed
Jacksonville, 32224, United States
Completed
Toledo, 43623, United States
Completed
Ann Arbor, 48106, United States
Completed
Cedar Rapids, 52403, United States
Completed
Avignon, 84000, France
Completed
Strasbourg Cedex, 67085, France
Completed
London, N6A 4L6, Canada
Completed
Montreal, H3T 1E2, Canada
Completed
Mississauga, L5M 2N1, Canada
Completed
Oshawa, L1G 2B9, Canada
Withdrawn
Quebec, G1R 2J6, Canada
Withdrawn
Vancouver, V5Z 4E6, Canada
Completed
Moncton, E1C 6Z8, Canada
Withdrawn
Winnipeg, R2H 2A6, Canada
Withdrawn
HOOFDDORP, 2134 TM, Netherlands
Completed
Leiden, 2333 ZA, Netherlands
Withdrawn
LEEUWARDEN, 8901 BR, Netherlands
Completed
Amsterdam, 1081 HV, Netherlands
Withdrawn
Buenos Aires, C1264AAA, Argentina
Withdrawn
Capital Federal-Buenos Aires, C1426ANZ, Argentina
Withdrawn
Buenos Aires, C1122AAL, Argentina
Withdrawn
San Miguel de Tucumán, T4000GTB, Argentina
Withdrawn
Rosario, S2000PBJ, Argentina
Completed
Santa Maria, 93454, United States
Completed
Charleston, 29414, United States
Withdrawn
Salt Lake City, 84106, United States
Withdrawn
St. Cloud, 56303, United States
Completed
Los Angeles, 90036, United States
Withdrawn
Fargo, 58122, United States
Withdrawn
Freiburg, 79106, Germany
Completed
Kumamoto, 860-8556, Japan
Completed
Fukuoka, 812-8582, Japan
Completed
Chiba, 260-8717, Japan
Completed
Shimotsuke, 329-0498, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Utsunomiya, 320-0834, Japan
Completed
Sapporo, 060-8648, Japan
Completed
Koto-ku, 135-8550, Japan
Completed
Matsuyama, 791-0280, Japan
Completed
Hidaka, 350-1298, Japan
Completed
Takatsuki, 569-8686, Japan
Completed
Kochi, 781-8555, Japan
Completed
Bunkyo-ku, 113-8519, Japan
Completed
Nagoya, 464-8681, Japan
Completed
Chuo-ku, 104-0045, Japan
Completed
Kita-Adachigun, 362-0806, Japan
Completed
Sunto, 411-8777, Japan
Completed
Kashiwa, 277-8577, Japan
Completed
Osaka, 540-0006, Japan
Completed
Osakasayama, 589-8511, Japan
Withdrawn
Green Bay, 54303, United States
Completed
Los Angeles, 90033, United States
Completed
Toronto, M4N 3M5, Canada
Withdrawn
Coimbra, 3030-075, Portugal
Withdrawn
ha'erbin, 150040, China
Withdrawn
Beijing, 100021, China
Withdrawn
Shanghai, 200030, China
Withdrawn
Qingdao, 266000, China
Withdrawn
Guangzhou, 510515, China
Withdrawn
shanghai, 200001, China
Withdrawn
Fuzhou, 350025, China
Withdrawn
Chongqing, 400042, China
Completed
Beijing, 100071, China
Withdrawn
Guangzhou, 510060, China
Withdrawn
fuzhou, 350014, China
Withdrawn
Nanjing, 210002, China
Withdrawn
Tianjin, 300060, China
Withdrawn
Hanghzou, 310009, China
Withdrawn
Nanjing, 210009, China
Withdrawn
Chongqing, 400038, China
Withdrawn
Changchun, 130021, China

Primary Outcome

  • Overall survival
    date_rangeTime 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).
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Progression-free survival (based on investigator’s assessment)
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
    enhanced_encryption
    Safety Issue:
    No
  • Objective tumor response
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
    enhanced_encryption
    Safety Issue:
    No
  • Disease control
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
    enhanced_encryption
    Safety Issue:
    No
  • Tumor response
    date_rangeTime Frame:
    From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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