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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Neoplasms

Intervention: Regorafenib (BAY73-4506) (Drug)

Phase: N/A

Status: Available

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Clinical Details

Official title: An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

Study design: N/A

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 - 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

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Wien 1090, Austria

Bruxelles - Brussel 1000, Belgium

Bruxelles - Brussel 1070, Belgium

Bruxelles - Brussel 1200, Belgium

Edegem 2650, Belgium

Leuven 3000, Belgium

Roeselare 8800, Belgium

Quebec G1R 2J6, Canada

Brno 65 653, Czech Republic

Praha 18081, Czech Republic

Aarhus C 8000, Denmark

Copenhagen 2100, Denmark

Helsinki 00180, Finland

HUS 00029, Finland

Avignon 84000, France

Bordeaux, France

CLERMONT-FERRAND Cedex 1 63003, France

Le Mans Cedex 2 72015, France

Lille Cedex 59020, France

Lille Cedex 59037, France

Marseille 13005, France

Montpellier Cedex 34298, France

Nice 06102, France

Paris Cedex 15 75908, France

Paris 75571, France

Paris 75651, France

Reims Cedex 51092, France

Saint Herblain 44805, France

Strasbourg Cedex 67085, France

Toulouse 31059, France

Berlin 12200, Germany

Hamburg 20251, Germany

Heraklion 711 10, Greece

Kifissia / Athens 14564, Greece

Budapest 1097, Hungary

Cork, Ireland

Dublin 24, Ireland

Beer Sheva 8410101, Israel

Haifa 3109601, Israel

Jerusalem 9112001, Israel

Petah Tikva 4941492, Israel

Tel Aviv 6423906, Israel

Ancona 60126, Italy

Brescia 25124, Italy

Firenze 50134, Italy

Genova 16132, Italy

Milano 20133, Italy

Milano 20162, Italy

Modena 41124, Italy

Napoli 80131, Italy

Padova 35128, Italy

Palermo 90127, Italy

Pisa 56126, Italy

Reggio Emilia 42100, Italy

Roma 00168, Italy

Aguascalientes 20230, Mexico

México, D.F. 14080, Mexico

Oaxaca 68000, Mexico

Veracruz 91910, Mexico

Amsterdam 1081 HV, Netherlands

Amsterdam 1105 AZ, Netherlands

Leiden 2333 ZA, Netherlands

Oslo 0450, Norway

Bialystok 15-027, Poland

Poznan 60-569, Poland

Coimbra 3030-075, Portugal

Porto 4200- 319, Portugal

Kazan 420029, Russian Federation

Krasnodar 350040, Russian Federation

Moscow 115478, Russian Federation

Moscow 119991, Russian Federation

Obninsk 249036, Russian Federation

Orenburg 460021, Russian Federation

St. Petersburg 197022, Russian Federation

St. Petersburg 197758, Russian Federation

A Coruña 15006, Spain

Barcelona 08035, Spain

Barcelona 08036, Spain

Madrid 28007, Spain

Madrid 28034, Spain

Madrid 28040, Spain

Madrid 28046, Spain

Madrid 28041, Spain

Málaga 29010, Spain

Sevilla 41013, Spain

Valencia 46014, Spain

Linköping 581 85, Sweden

Uppsala 751 85, Sweden

Bern 3010, Switzerland

Genève 1211, Switzerland

Zürich 8091, Switzerland

Manchester M20 4BX, United Kingdom

Calgary, Alberta T2N 4N2, Canada

Edmonton, Alberta T6G 1Z2, Canada

Córdoba, Andalucía 14004, Spain

Esslingen, Baden-Württemberg 73730, Germany

Freiburg, Baden-Württemberg 79106, Germany

Heidelberg, Baden-Württemberg 69120, Germany

Mannheim, Baden-Württemberg 68167, Germany

Stuttgart, Baden-Württemberg 70199, Germany

Ulm, Baden-Württemberg 89081, Germany

Badalona (Barcelona), Barcelona 08916, Spain

Hospitalet de Llobregat, Barcelona 08907, Spain

Sabadell, Barcelona 08208, Spain

Basel, Basel-Stadt 4031, Switzerland

München, Bayern 81377, Germany

München, Bayern 81737, Germany

München, Bayern 81925, Germany

Duarte, California 91010, United States

La Jolla, California 92093-0987, United States

La Jolla, California 92037, United States

Long Beach, California 90813, United States

Los Angeles, California 90033, United States

Orange, California 92868-3201, United States

Santa Maria, California 93454, United States

Santander, Cantabria 39008, Spain

Denver, Colorado 80218, United States

New Haven, Connecticut 06520, United States

Washington, District of Columbia 20007, United States

Mexico, D.F., Distrito Federal 01120, Mexico

Mexico, D.F., Distrito Federal 14050, Mexico

México, Distrito Federal 14080, Mexico

Aventura, Florida 33180, United States

Jacksonville, Florida 32224, United States

Miami Beach, Florida 33140, United States

Ocala, Florida 34474, United States

Orlando, Florida 32804, United States

San Giovanni Rotondo, Foggia 71013, Italy

Atlanta, Georgia 30318, United States

Columbus, Georgia 31904, United States

Savannah, Georgia 31405, United States

Chur, Graubünden 7000, Switzerland

Irapuato, Guanajuato 36500, Mexico

Park Ridge, Illinois 60068, United States

Cedar Rapids, Iowa 52403, United States

Sioux City, Iowa 51101, United States

Guadalajara, Jalisco 44670, Mexico

Louisville, Kentucky 40202, United States

Leicester, Leicestershire LE1 5WW, United Kingdom

New Orleans, Louisiana 70121, United States

Shreveport, Louisiana 71130, United States

Brewer, Maine 04412, United States

Boston, Massachusetts 02215-5450, United States

Burlington, Massachusetts 01805, United States

Ann Arbor, Michigan 48106, United States

Detroit, Michigan 48202, United States

Detroit, Michigan 48201, United States

Rozzano, Milano 20089, Italy

Rochester, Minnesota 55905, United States

Jackson, Mississippi 39202, United States

Jefferson City, Missouri 65109, United States

Toluca, México 50180, Mexico

Omaha, Nebraska 68106, United States

Las Vegas, Nevada 89169, United States

Lebanon, New Hampshire 03756, United States

Concord, New South Wales 2139, Australia

St Leonards, New South Wales 2065, Australia

Bronx, New York 10461, United States

Lake Success, New York 11042, United States

New York, New York 10021, United States

New York, New York 10016, United States

New York, New York 10003, United States

Stony Brook, New York 11794, United States

Hannover, Niedersachsen 30625, Germany

Oldenburg, Niedersachsen 26133, Germany

Bochum, Nordrhein-Westfalen 44892, Germany

Essen, Nordrhein-Westfalen 45122, Germany

Herne, Nordrhein-Westfalen 44625, Germany

Köln, Nordrhein-Westfalen 50924, Germany

Leverkusen, Nordrhein-Westfalen 51375, Germany

Mönchengladbach, Nordrhein-Westfalen 41063, Germany

Porta Westfalica, Nordrhein-Westfalen 32457, Germany

Recklinghausen, Nordrhein-Westfalen 45657, Germany

Charlotte, North Carolina 28203, United States

Winston-Salem, North Carolina 27157, United States

Fargo, North Dakota 58122, United States

Wels, Oberösterreich 4600, Austria

Cincinnati, Ohio 45219, United States

Cleveland, Ohio 44195, United States

Toledo, Ohio 43617, United States

Mississauga, Ontario L5M 2N1, Canada

Oshawa, Ontario L1G 2B9, Canada

Toronto, Ontario M4N 3M5, Canada

Portland, Oregon 97239, United States

Philadelpahia, Pennsylvania 19107, United States

Philadelphia, Pennsylvania 19111-2497, United States

Philadelphia, Pennsylvania 19104, United States

Montreal, Quebec H2W 1S6, Canada

Trier, Rheinland-Pfalz 54290, Germany

Providence, Rhode Island 02908, United States

Dresden, Sachsen 01307, Germany

Halle, Sachsen-Anhalt 06120, Germany

Magdeburg, Sachsen-Anhalt 39104, Germany

Woodville South, South Australia 5011, Australia

Charleston, South Carolina 29414, United States

Sumter, South Carolina 29150, United States

Graz, Steiermark 8036, Austria

Memphis, Tennessee 38120, United States

Nashville, Tennessee 37232, United States

Dallas, Texas 75390-9110, United States

Temple, Texas 76508, United States

Innsbruck, Tirol 6020, Austria

Footscray, Victoria 3011, Australia

Parkville, Victoria 3050, Australia

Portsmouth, Virginia 23704, United States

Richmond, Virginia 23298-0037, United States

Seattle, Washington 98104, United States

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Last updated: August 6, 2015

Page last updated: August 23, 2015

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