Trial Condition(s):
Metastatic Colorectal Cancer
Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy
Bayer Identifier:
14387
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Halle, Germany, 06120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oldenburg, Germany, 26133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE CEDEX, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LE MANS CEDEX 2, France, 72015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20162 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brescia, Italy, 25124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porta Westfalica, Germany, 32457 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stuttgart, Germany, 70199 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81737 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81925 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER, France, 34298 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site REIMS, France, 51092 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75651 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Oscar Lambret - Lille LILLE CEDEX, France, 59020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha, Czech Republic, 18081 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brno, Czech Republic, 65 653 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hradec Kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5266202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Concord, Australia, 2139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woodville South, Australia, 5011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Modena, Italy, 41124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reggio Emilia, Italy, 42123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olomouc, Czech Republic, 779 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ankara, Turkey, 06500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parkville, Australia, 3050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Footscray, Australia, 3011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szeged, Hungary, 6725 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Istanbul, Turkey, 34093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genève, Switzerland, 1211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trier, Germany, 54290 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sumter, United States, 29150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Scranton, United States, 18510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jefferson City, United States, 65109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aventura, United States, 33180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75390-9110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Peoria, United States, 61615-7828 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Orleans, United States, 70121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Neptune, United States, 07754 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32224 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toledo, United States, 43623 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ann Arbor, United States, 48106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cedar Rapids, United States, 52403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Avignon, France, 84000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Strasbourg Cedex, France, 67085 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N6A 4L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mississauga, Canada, L5M 2N1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oshawa, Canada, L1G 2B9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moncton, Canada, E1C 6Z8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leiden, Netherlands, 2333 ZA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amsterdam, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santa Maria, United States, 93454 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 29414 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kumamoto, Japan, 860-8556 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba, Japan, 260-8717 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shimotsuke, Japan, 329-0498 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mitaka, Japan, 181-8611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Utsunomiya, Japan, 320-0834 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koto-ku, Japan, 135-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsuyama, Japan, 791-0280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hidaka, Japan, 350-1298 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takatsuki, Japan, 569-8686 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kochi, Japan, 781-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8519 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 464-8681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kita-Adachigun, Japan, 362-0806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sunto, Japan, 411-8777 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashiwa, Japan, 277-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 540-0006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100071 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Overall survivalTimeframe: 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
- Progression-free survival (based on investigator’s assessment)Timeframe: 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.
- Objective tumor responseTimeframe: 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.
- Disease controlTimeframe: 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.
- Tumor responseTimeframe: 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.
Additional Information
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