This is a phase III B, prospective, interventional, open-label, single-arm, multicenterstudy to provide regorafenib to subjects diagnosed with metastatic colorectal cancer whohave failed after standard therapy and for whom no therapy alternatives exist, in thetime between positive results and approval / availability on the market, and to collectsafety data for regorafenib until market access.Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinaseinhibitor targets certain key proteins that are essential for the survival of the cancercell. By specifically targeting these proteins, regorafenib may stop cancer growth. Thegrowth of the tumor may be decreased by preventing these specific proteins fromfunctioning.The primary endpoint of this study will be safety.
Not Provided
Drug: Regorafenib (BAY73-4506)
Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week
cycle (i.e., 3 weeks on, 1 week off). Subjects will continue on treatment until at least
one of the following occurs (main criteria):
Progressive Disease (PD). The subject may continue treatment at the investigator's
discretion.
Death Unacceptable toxicity Subject withdraws consent Treating physician determines
discontinuation of treatment is in the subject's best interest Substantial non-compliance
with the protocol
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
- 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
Duarte, California, United States
La Jolla, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Orange, California, United States
Santa Maria, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington, District of Columbia, United States
Aventura, Florida, United States
Jacksonville, Florida, United States
Miami Beach, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Savannah, Georgia, United States
Park Ridge, Illinois, United States
Cedar Rapids, Iowa, United States
Sioux City, Iowa, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Brewer, Maine, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
Jackson, Mississippi, United States
Jefferson City, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
Bronx, New York, United States
Lake Success, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Sumter, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Temple, Texas, United States
Portsmouth, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Concord, New South Wales, Australia
St Leonards, New South Wales, Australia
Woodville South, South Australia, Australia
Footscray, Victoria, Australia
Parkville, Victoria, Australia
Wels, Oberösterreich, Austria
Graz, Steiermark, Austria
Innsbruck, Tirol, Austria
Wien, Austria
Bruxelles - Brussel, Belgium
Bruxelles - Brussel, Belgium
Bruxelles - Brussel, Belgium
Edegem, Belgium
Leuven, Belgium
Roeselare, Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Mississauga, Ontario, Canada
Oshawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Quebec, Canada
Brno, Czechia
Praha, Czechia
Aarhus C, Denmark
Copenhagen, Denmark
Helsinki, Finland
HUS, Finland
Avignon, France
Bordeaux, France
CLERMONT-FERRAND Cedex 1, France
Le Mans Cedex 2, France
Lille Cedex, France
Lille Cedex, France
Marseille, France
Montpellier Cedex, France
Nice, France
Paris Cedex 15, France
Paris, France
Paris, France
Reims Cedex, France
Saint Herblain, France
Strasbourg Cedex, France
Toulouse, France
Esslingen, Baden-Württemberg, Germany
Freiburg, Baden-Württemberg, Germany
Heidelberg, Baden-Württemberg, Germany
Mannheim, Baden-Württemberg, Germany
Stuttgart, Baden-Württemberg, Germany
Ulm, Baden-Württemberg, Germany
München, Bayern, Germany
München, Bayern, Germany
München, Bayern, Germany
Hannover, Niedersachsen, Germany
Oldenburg, Niedersachsen, Germany
Bochum, Nordrhein-Westfalen, Germany
Essen, Nordrhein-Westfalen, Germany
Herne, Nordrhein-Westfalen, Germany
Köln, Nordrhein-Westfalen, Germany
Leverkusen, Nordrhein-Westfalen, Germany
Mönchengladbach, Nordrhein-Westfalen, Germany
Porta Westfalica, Nordrhein-Westfalen, Germany
Recklinghausen, Nordrhein-Westfalen, Germany
Trier, Rheinland-Pfalz, Germany
Halle, Sachsen-Anhalt, Germany
Magdeburg, Sachsen-Anhalt, Germany
Dresden, Sachsen, Germany
Berlin, Germany
Hamburg, Germany
Heraklion, Greece
Kifissia / Athens, Greece
Budapest, Hungary
Cork, Ireland
Dublin, Ireland
Beer Sheva, Israel
Haifa, Israel
Jerusalem, Israel
Petah Tikva, Israel
Tel Aviv, Israel
Napoli, Campania, Italy
Modena, Emilia-Romagna, Italy
Reggio Emilia, Emilia-Romagna, Italy
Roma, Lazio, Italy
Genova, Liguria, Italy
Brescia, Lombardia, Italy
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Ancona, Marche, Italy
Foggia, Puglia, Italy
Palermo, Sicilia, Italy
Firenze, Toscana, Italy
Pisa, Toscana, Italy
Padova, Veneto, Italy
Mexico, D.F., Distrito Federal, Mexico
Mexico, D.F., Distrito Federal, Mexico
México, D.F., Distrito Federal, Mexico
México, Distrito Federal, Mexico
Irapuato, Guanajuato, Mexico
Guadalajara, Jalisco, Mexico
Aguascalientes, Mexico
Oaxaca, Mexico
Toluca, Mexico
Veracruz, Mexico
Amsterdam, Netherlands
Amsterdam, Netherlands
Leiden, Netherlands
Oslo, Norway
Bialystok, Poland
Poznan, Poland
Coimbra, Portugal
Porto, Portugal
Kazan, Russian Federation
Krasnodar, Russian Federation
Moscow, Russian Federation
Moscow, Russian Federation
Obninsk, Russian Federation
Orenburg, Russian Federation
St. Petersburg, Russian Federation
St. Petersburg, Russian Federation
Córdoba, Andalucía, Spain
Badalona (Barcelona), Barcelona, Spain
Hospitalet de Llobregat, Barcelona, Spain
Sabadell, Barcelona, Spain
Santander, Cantabria, Spain
A Coruña, Spain
Barcelona, Spain
Barcelona, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Málaga, Spain
Sevilla, Spain
Valencia, Spain
Linköping, Sweden
Uppsala, Sweden
Basel, Basel-Stadt, Switzerland
Chur, Graubünden, Switzerland
Bern, Switzerland
Genève, Switzerland
Zürich, Switzerland
Leicester, Leicestershire, United Kingdom
Manchester, United Kingdom
Bayer Study Director, Study Director
Bayer