Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
Launched by BAYER · Feb 21, 2012
Trial Information
Current as of April 30, 2025
No longer available
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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. All other histological types are excluded.
- • 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)
- • ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
- • Adequate bone marrow, liver and renal function
- • Women of childbearing potential and men must agree to use adequate contraception
- Exclusion Criteria:
- • Prior treatment with regorafenib
- • Congestive heart failure \>/= New York Heart Association (NYHA) class 2
- • Uncontrolled hypertension (Systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management)
- • Any hemorrhage or bleeding event \>/= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
- • Persistent proteinuria of CTCAE Grade 3 (\>3.5g/24 hours)
- • Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity \</= Grade 2
- • Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Wien, , Austria
Calgary, Alberta, Canada
Tel Aviv, , Israel
Madrid, , Spain
Bern, , Switzerland
Zürich, , Switzerland
Manchester, , United Kingdom
Edmonton, Alberta, Canada
Oshawa, Ontario, Canada
Toronto, Ontario, Canada
Amsterdam, , Netherlands
Bialystok, , Poland
Kazan, , Russian Federation
Moscow, , Russian Federation
Rochester, Minnesota, United States
Barcelona, , Spain
Louisville, Kentucky, United States
Charlotte, North Carolina, United States
Fargo, North Dakota, United States
Temple, Texas, United States
Seattle, Washington, United States
Winston Salem, North Carolina, United States
Detroit, Michigan, United States
Bruxelles Brussel, , Belgium
Leuven, , Belgium
Lille Cedex, , France
Marseille, , France
Saint Herblain, , France
Miami Beach, Florida, United States
Memphis, Tennessee, United States
Freiburg, Baden Württemberg, Germany
Berlin, , Germany
La Jolla, California, United States
Montpellier Cedex, , France
Heidelberg, Baden Württemberg, Germany
München, Bayern, Germany
Ocala, Florida, United States
Providence, Rhode Island, United States
Stony Brook, New York, United States
Leicester, Leicestershire, United Kingdom
Nashville, Tennessee, United States
Hamburg, , Germany
Los Angeles, California, United States
Denver, Colorado, United States
Portland, Oregon, United States
New Orleans, Louisiana, United States
Ann Arbor, Michigan, United States
Mississauga, Ontario, Canada
Cork, , Ireland
Málaga, , Spain
Uppsala, , Sweden
Montreal, Quebec, Canada
Beer Sheva, , Israel
Bronx, New York, United States
Paris Cedex 15, , France
Mannheim, Baden Württemberg, Germany
Dresden, Sachsen, Germany
Haifa, , Israel
Obninsk, , Russian Federation
Toulouse, , France
Edegem, , Belgium
Hus, , Finland
Burlington, Massachusetts, United States
New York, New York, United States
Valencia, , Spain
Jefferson City, Missouri, United States
Park Ridge, Illinois, United States
New Haven, Connecticut, United States
Cincinnati, Ohio, United States
Orlando, Florida, United States
Jacksonville, Florida, United States
Lebanon, New Hampshire, United States
Footscray, Victoria, Australia
Parkville, Victoria, Australia
Shreveport, Louisiana, United States
Savannah, Georgia, United States
Sevilla, , Spain
Bordeaux, , France
Poznan, , Poland
Graz, Steiermark, Austria
Innsbruck, Tirol, Austria
Aarhus C, , Denmark
Hannover, Niedersachsen, Germany
Halle, Sachsen Anhalt, Germany
St. Petersburg, , Russian Federation
Stuttgart, Baden Württemberg, Germany
Quebec, , Canada
Essen, Nordrhein Westfalen, Germany
México, Distrito Federal, Mexico
Krasnodar, , Russian Federation
Washington, District Of Columbia, United States
Santa Maria, California, United States
Aventura, Florida, United States
Lake Success, New York, United States
Trier, Rheinland Pfalz, Germany
Duarte, California, United States
Long Beach, California, United States
Columbus, Georgia, United States
Cedar Rapids, Iowa, United States
Sioux City, Iowa, United States
Concord, New South Wales, Australia
Sumter, South Carolina, United States
Roma, Lazio, Italy
Hospitalet De Llobregat, Barcelona, Spain
Ulm, Baden Württemberg, Germany
Basel, Basel Stadt, Switzerland
Helsinki, , Finland
Copenhagen, , Denmark
Köln, Nordrhein Westfalen, Germany
Leiden, , Netherlands
Jackson, Mississippi, United States
Atlanta, Georgia, United States
Aguascalientes, , Mexico
Magdeburg, Sachsen Anhalt, Germany
Richmond, Virginia, United States
Leverkusen, Nordrhein Westfalen, Germany
Linköping, , Sweden
Paris, , France
Charleston, South Carolina, United States
Wels, Oberösterreich, Austria
Roeselare, , Belgium
Veracruz, , Mexico
Genova, Liguria, Italy
Sabadell, Barcelona, Spain
Avignon, , France
Woodville South, South Australia, Australia
Budapest, , Hungary
Palermo, Sicilia, Italy
St Leonards, New South Wales, Australia
Chur, Graubünden, Switzerland
Le Mans Cedex 2, , France
A Coruña, , Spain
Napoli, Campania, Italy
Santander, Cantabria, Spain
Jerusalem, , Israel
Orenburg, , Russian Federation
Mönchengladbach, Nordrhein Westfalen, Germany
Porta Westfalica, Nordrhein Westfalen, Germany
Reims Cedex, , France
Esslingen, Baden Württemberg, Germany
Reggio Emilia, Emilia Romagna, Italy
Milano, Lombardia, Italy
Pisa, Toscana, Italy
Toledo, Ohio, United States
Herne, Nordrhein Westfalen, Germany
Dublin, , Ireland
Modena, Emilia Romagna, Italy
Padova, Veneto, Italy
México, D.F., Distrito Federal, Mexico
Las Vegas, Nevada, United States
Oslo, , Norway
Heraklion, , Greece
Guadalajara, Jalisco, Mexico
Petah Tikva, , Israel
Oaxaca, , Mexico
Toluca, , Mexico
Boston, Massachusetts, United States
Oldenburg, Niedersachsen, Germany
Genève, , Switzerland
Firenze, Toscana, Italy
Dallas, Texas, United States
Strasbourg Cedex, , France
Coimbra, , Portugal
Bochum, Nordrhein Westfalen, Germany
Clermont Ferrand Cedex 1, , France
Ancona, Marche, Italy
Brescia, Lombardia, Italy
Orange, California, United States
Brewer, Maine, United States
Omaha, Nebraska, United States
Portsmouth, Virginia, United States
Brno, , Czechia
Praha, , Czechia
Nice, , France
Recklinghausen, Nordrhein Westfalen, Germany
Kifissia / Athens, , Greece
Foggia, Puglia, Italy
Mexico, D.F., Distrito Federal, Mexico
Irapuato, Guanajuato, Mexico
Porto, , Portugal
Córdoba, Andalucía, Spain
Badalona (Barcelona), Barcelona, Spain
Patients applied
Trial Officials
Bayer Study Director
Study Director
Bayer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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