Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

NCT01538680 | Unknown

• 2 other identifiers: 159672011-005836-25
• Study Type: expanded_access
• Target: N/A
• Locations: 24 countries
• Sites: 203

Brief Summary

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint of this study will be safety.

Conditions

Colorectal Neoplasms

Interventions

Regorafenib (BAY73-4506) DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (207)

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Duarte, California, 91010, United States

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La Jolla, California, 92037, United States

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La Jolla, California, 92093-0987, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90033, United States

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Orange, California, 92868-3201, United States

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Santa Maria, California, 93454, United States

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Denver, Colorado, 80218, United States

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New Haven, Connecticut, 06520, United States

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Washington D.C., District of Columbia, 20007, United States

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Aventura, Florida, 33180, United States

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Jacksonville, Florida, 32224, United States

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Miami Beach, Florida, 33140, United States

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Ocala, Florida, 34474, United States

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Orlando, Florida, 32804, United States

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Atlanta, Georgia, 30318, United States

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Columbus, Georgia, 31904, United States

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Savannah, Georgia, 31405, United States

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Park Ridge, Illinois, 60068, United States

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Cedar Rapids, Iowa, 52403, United States

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Sioux City, Iowa, 51101, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70121, United States

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Shreveport, Louisiana, 71130, United States

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Brewer, Maine, 04412, United States

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Boston, Massachusetts, 02215-5450, United States

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Burlington, Massachusetts, 01805, United States

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Ann Arbor, Michigan, 48106, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Rochester, Minnesota, 55905, United States

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Jackson, Mississippi, 39202, United States

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Jefferson City, Missouri, 65109, United States

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Omaha, Nebraska, 68106, United States

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Las Vegas, Nevada, 89169, United States

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Lebanon, New Hampshire, 03756, United States

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Lake Success, New York, 11042, United States

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New York, New York, 10003, United States

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New York, New York, 10016, United States

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New York, New York, 10021, United States

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Stony Brook, New York, 11794, United States

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The Bronx, New York, 10461, United States

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Charlotte, North Carolina, 28203, United States

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Winston-Salem, North Carolina, 27157, United States

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Fargo, North Dakota, 58122, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44195, United States

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Toledo, Ohio, 43617, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19111-2497, United States

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Providence, Rhode Island, 02908, United States

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Charleston, South Carolina, 29414, United States

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Sumter, South Carolina, 29150, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37232, United States

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Dallas, Texas, 75390-9110, United States

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Temple, Texas, 76508, United States

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Portsmouth, Virginia, 23704, United States

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Richmond, Virginia, 23298-0037, United States

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Seattle, Washington, 98104, United States

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Concord, New South Wales, 2139, Australia

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St Leonards, New South Wales, 2065, Australia

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Woodville South, South Australia, 5011, Australia

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Footscray, Victoria, 3011, Australia

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Parkville, Victoria, 3050, Australia

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Graz, Styria, 8036, Austria

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Innsbruck, Tyrol, 6020, Austria

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Wels, Upper Austria, 4600, Austria

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Vienna, 1090, Austria

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Bruxelles - Brussel, 1000, Belgium

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Bruxelles - Brussel, 1070, Belgium

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Bruxelles - Brussel, 1200, Belgium

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Edegem, 2650, Belgium

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Leuven, 3000, Belgium

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Roeselare, 8800, Belgium

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Calgary, Alberta, T2N 4N2, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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Mississauga, Ontario, L5M 2N1, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H2W 1S6, Canada

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Québec, G1R 2J6, Canada

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Brno, 65 653, Czechia

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Prague, 18081, Czechia

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Aarhus C, 8000, Denmark

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Copenhagen, 2100, Denmark

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Helsinki, 00180, Finland

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HUS, 00029, Finland

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Avignon, 84000, France

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Bordeaux, France

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Clermont-Ferrand, 63003, France

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Le Mans, 72015, France

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Lille, 59020, France

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Lille, 59037, France

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Marseille, 13005, France

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Montpellier, 34298, France

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Nice, 06102, France

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Paris, 75571, France

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Paris, 75651, France

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Paris, 75908, France

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Reims, 51092, France

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Saint-Herblain, 44805, France

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Strasbourg, 67085, France

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Toulouse, 31059, France

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Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Stuttgart, Baden-Wurttemberg, 70199, Germany

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Ulm, Baden-Wurttemberg, 89081, Germany

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München, Bavaria, 81377, Germany

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München, Bavaria, 81737, Germany

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München, Bavaria, 81925, Germany

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Hanover, Lower Saxony, 30625, Germany

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Oldenburg, Lower Saxony, 26133, Germany

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Bochum, North Rhine-Westphalia, 44892, Germany

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Cologne, North Rhine-Westphalia, 50924, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Herne, North Rhine-Westphalia, 44625, Germany

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Leverkusen, North Rhine-Westphalia, 51375, Germany

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Mönchengladbach, North Rhine-Westphalia, 41063, Germany

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Porta Westfalica, North Rhine-Westphalia, 32457, Germany

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Recklinghausen, North Rhine-Westphalia, 45657, Germany

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Trier, Rhineland-Palatinate, 54290, Germany

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Dresden, Saxony, 01307, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Magdeburg, Saxony-Anhalt, 39104, Germany

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Berlin, 12200, Germany

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Hamburg, 20246, Germany

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Heraklion, 711 10, Greece

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Kifissia / Athens, 14564, Greece

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Budapest, 1097, Hungary

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Cork, Ireland

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Dublin, 24, Ireland

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Beersheba, 8410101, Israel

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Haifa, 3109601, Israel

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Jerusalem, 9112001, Israel

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Petah Tikva, 4941492, Israel

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Tel Aviv, 6423906, Israel

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Foggia, Apulia, 71013, Italy

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Napoli, Campania, 80131, Italy

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Modena, Emilia-Romagna, 41124, Italy

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Reggio Emilia, Emilia-Romagna, 42123, Italy

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Rome, Lazio, 00168, Italy

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Genoa, Liguria, 16132, Italy

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Brescia, Lombardy, 25124, Italy

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Milan, Lombardy, 20089, Italy

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Milan, Lombardy, 20133, Italy

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Milan, Lombardy, 20162, Italy

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Palermo, Sicily, 90127, Italy

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Ancona, The Marches, 60126, Italy

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Florence, Tuscany, 50134, Italy

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Pisa, Tuscany, 56126, Italy

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Padua, Veneto, 35128, Italy

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Irapuato, Guanajuato, 36500, Mexico

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Guadalajara, Jalisco, 44670, Mexico

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Mexico City, Mexico City, 01120, Mexico

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Mexico City, Mexico City, 14050, Mexico

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Mexico City, Mexico City, 14080, Mexico

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México, D.F., Mexico City, 14080, Mexico

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Aguascalientes, 20230, Mexico

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Oaxaca City, 68000, Mexico

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Toluca, 50180, Mexico

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Veracruz, 91910, Mexico

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Amsterdam, 1081 HV, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Leiden, 2333 ZA, Netherlands

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Oslo, 0450, Norway

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Bialystok, 15-027, Poland

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Poznan, 60-569, Poland

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Coimbra, 3030-075, Portugal

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Porto, 4200- 319, Portugal

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Kazan', 420029, Russia

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Krasnodar, 350040, Russia

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Moscow, 115478, Russia

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Moscow, 119991, Russia

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Obninsk, 249036, Russia

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Orenburg, 460021, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Córdoba, Andalusia, 14004, Spain

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Badalona (Barcelona), Barcelona, 08916, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Sabadell, Barcelona, 08208, Spain

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Santander, Cantabria, 39008, Spain

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A Coruña, 15006, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Málaga, 29010, Spain

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Seville, 41013, Spain

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Valencia, 46014, Spain

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Linköping, 581 85, Sweden

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Uppsala, 751 85, Sweden

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Basel, Canton of Basel-City, 4031, Switzerland

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Chur, Kanton Graubünden, 7000, Switzerland

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Bern, 3010, Switzerland

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Geneva, 1205, Switzerland

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Zurich, 8091, Switzerland

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Leicester, Leicestershire, LE1 5WW, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Related Publications (2)

• Cervantes A, Tabernero J, Garcia-Carbonero R, Sastre J, Feliu J, Carmen Guillen-Ponce, Paredes BG, Carral A, Munoz J. Regorafenib in patients with metastatic colorectal cancer in Spain: from clinical trials to real-world evidence. Future Oncol. 2024;20(20):1401-1413. doi: 10.1080/14796694.2024.2340422. Epub 2024 Jun 11.

  PMID: 38861286 DERIVED

• Van Cutsem E, Martinelli E, Cascinu S, Sobrero A, Banzi M, Seitz JF, Barone C, Ychou M, Peeters M, Brenner B, Hofheinz RD, Maiello E, Andre T, Spallanzani A, Garcia-Carbonero R, Arriaga YE, Verma U, Grothey A, Kappeler C, Miriyala A, Kalmus J, Falcone A, Zaniboni A. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist. 2019 Feb;24(2):185-192. doi: 10.1634/theoncologist.2018-0072. Epub 2018 Sep 6.

  PMID: 30190299 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: February 24, 2012
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

GB (2); AU (5); ME (10); FR (16); HU (1); IT (15); US (62); IL (5); DK (2); FI (2); DE (25); GR (2); BE (6); IE (2); NL (3); PL (2); PT (2); ES (16); SE (2); RU (8); CH (5); CA (7); CZ (2); NO (1)