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

Expanded access is currently available for this treatment.
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01538680
First received: February 21, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
Drug: Regorafenib (BAY73-4506)

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

Resource links provided by NLM:


Further study details as provided by Bayer:

Intervention Details:
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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 </= 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538680

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Hide Study Locations
Locations
United States, California
Duarte, California, United States, 91010
La Jolla, California, United States, 92037
La Jolla, California, United States, 92093-0987
Long Beach, California, United States, 90813
Los Angeles, California, United States, 90033
Orange, California, United States, 92868-3201
United States, Colorado
Denver, Colorado, United States, 80218
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Aventura, Florida, United States, 33180
Jacksonville, Florida, United States, 32224
Miami Beach, Florida, United States, 33140
Ocala, Florida, United States, 34474
Orlando, Florida, United States, 32804
Tampa, Florida, United States, 33607
United States, Georgia
Atlanta, Georgia, United States, 30309
Columbus, Georgia, United States, 31904
Savannah, Georgia, United States, 31405
United States, Illinois
Park Ridge, Illinois, United States, 60068
United States, Iowa
Cedar Rapids, Iowa, United States, 52403
Sioux City, Iowa, United States, 51101
United States, Kansas
Wichita, Kansas, United States, 67208
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70121
Shreveport, Louisiana, United States, 71130
United States, Maine
Brewer, Maine, United States, 04412
United States, Massachusetts
Boston, Massachusetts, United States, 02215-5450
Burlington, Massachusetts, United States, 01805
United States, Michigan
Ann Arbor, Michigan, United States, 48106
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Jefferson City, Missouri, United States, 65109
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Nevada
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New York
Lake Success, New York, United States, 11042
New York, New York, United States, 10016
New York, New York, United States, 10021
New York, New York, United States, 10003
Stony Brook, New York, United States, 11794
United States, North Carolina
Charlotte, North Carolina, United States, 28203
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Fargo, North Dakota, United States, 58122
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44195
Toledo, Ohio, United States, 43617
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelpahia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19111-2497
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Providence, Rhode Island, United States, 02908
United States, South Carolina
Charleston, South Carolina, United States, 29414
Sumter, South Carolina, United States, 29150
United States, Tennessee
Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75390-9110
Temple, Texas, United States, 76508
United States, Virginia
Portsmouth, Virginia, United States, 23704
Richmond, Virginia, United States, 23298
United States, Washington
Seattle, Washington, United States, 98122-4307
Australia, New South Wales
Concord, New South Wales, Australia, 2139
St Leonards, New South Wales, Australia, 2065
Australia, South Australia
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Footscray, Victoria, Australia, 3011
Parkville, Victoria, Australia, 3050
Austria
Wels, Oberösterreich, Austria, 4600
Graz, Steiermark, Austria, 8036
Innsbruck, Tirol, Austria, 6020
Wien, Austria, 1090
Belgium
Bruxelles - Brussel, Belgium, 1200
Bruxelles - Brussel, Belgium, 1000
Bruxelles - Brussel, Belgium, 1070
Edegem, Belgium, 2650
Leuven, Belgium, 3000
Roeselare, Belgium, 8800
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Mississauga, Ontario, Canada, L5M 2N1
Oshawa, Ontario, Canada, L1G 2B9
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H2W 1S6
Canada
Quebec, Canada, G1R 2J6
Czech Republic
Brno, Czech Republic, 65 653
Praha, Czech Republic, 18081
Denmark
Aarhus C, Denmark, 8000
Copenhagen, Denmark, 2100
Finland
Helsinki, Finland, 00180
Helsinki, Finland, 00029
France
Avignon, France, 84000
Bordeaux, France
CLERMONT-FERRAND Cedex 1, France, 63003
Le Mans Cedex 2, France, 72015
Lille Cedex, France, 59037
Lille Cedex, France, 59020
Marseille, France, 13005
Montpellier Cedex, France, 34298
Nice, France, 06102
Paris, France, 75571
Paris, France, 75651
Paris Cedex 15, France, 75908
Reims Cedex, France, 51092
Saint Herblain, France, 44805
Strasbourg Cedex, France, 67085
Toulouse, France, 31059
Germany
Esslingen, Baden-Württemberg, Germany, 73730
Freiburg, Baden-Württemberg, Germany, 79106
Heidelberg, Baden-Württemberg, Germany, 69120
Mannheim, Baden-Württemberg, Germany, 68167
Stuttgart, Baden-Württemberg, Germany, 70199
Ulm, Baden-Württemberg, Germany, 89081
München, Bayern, Germany, 81377
München, Bayern, Germany, 81737
München, Bayern, Germany, 81925
Hannover, Niedersachsen, Germany, 30625
Oldenburg, Niedersachsen, Germany, 26133
Bochum, Nordrhein-Westfalen, Germany, 44892
Essen, Nordrhein-Westfalen, Germany, 45122
Herne, Nordrhein-Westfalen, Germany, 44625
Köln, Nordrhein-Westfalen, Germany, 50924
Leverkusen, Nordrhein-Westfalen, Germany, 51375
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
Recklinghausen, Nordrhein-Westfalen, Germany, 45657
Trier, Rheinland-Pfalz, Germany, 54290
Halle, Sachsen-Anhalt, Germany, 06120
Magdeburg, Sachsen-Anhalt, Germany, 39104
Dresden, Sachsen, Germany, 01307
Berlin, Germany, 12200
Hamburg, Germany, 20251
Greece
Heraklion, Greece, 711 10
Kifissia / Athens, Greece, 14564
Hungary
Budapest, Hungary, 1097
Ireland
Cork, Ireland
Dublin, Ireland, 24
Israel
Beer Sheva, Israel, 8410101
Haifa, Israel, 3525408
Jerusalem, Israel, 9112001
Petach Tikva, Israel, 4941492
Tel Aviv, Israel, 6423906
Italy
San Giovanni Rotondo, Foggia, Italy, 71013
Rozzano, Milano, Italy, 20089
Ancona, Italy, 60126
Brescia, Italy, 25124
Firenze, Italy, 50134
Genova, Italy, 16132
Milano, Italy, 20162
Milano, Italy, 20133
Modena, Italy, 41124
Napoli, Italy, 80131
Padova, Italy, 35128
Palermo, Italy, 90127
Pisa, Italy, 56126
Reggio Emilia, Italy, 42100
Roma, Italy, 00168
Mexico
Mexico, D.F., Distrito Federal, Mexico, 14050
Mexico, D.F., Distrito Federal, Mexico, 01120
México, Distrito Federal, Mexico, 14080
Irapuato, Guanajuato, Mexico, 36500
Guadalajara, Jalisco, Mexico, 44670
Toluca, México, Mexico, 50180
Aguascalientes, Mexico, 20230
México, D.F., Mexico, 14080
Oaxaca, Mexico, 68000
Veracruz, Mexico, 91910
Netherlands
Amsterdam, Netherlands, 1081 HV
Amsterdam, Netherlands, 1105 AZ
Leiden, Netherlands, 2333 ZA
Norway
Oslo, Norway, 0450
Poland
Bialystok, Poland, 15-027
Poznan, Poland, 60-569
Portugal
Coimbra, Portugal, 3030-075
Porto, Portugal, 4200- 319
Russian Federation
Kazan, Russian Federation, 420029
Krasnodar, Russian Federation, 350040
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 119992
Obninsk, Russian Federation, 249036
Orenburg, Russian Federation, 460021
St. Petersburg, Russian Federation, 197022
St. Petersburg, Russian Federation, 198255
Spain
Córdoba, Andalucía, Spain, 14004
Badalona (Barcelona), Barcelona, Spain, 08916
Hospitalet de Llobregat, Barcelona, Spain, 08907
Sabadell, Barcelona, Spain, 08208
Santander, Cantabria, Spain, 39008
A Coruña, Spain, 15006
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Madrid, Spain, 28041
Madrid, Spain, 28040
Madrid, Spain, 28046
Madrid, Spain, 28034
Madrid, Spain, 28007
Málaga, Spain, 29010
Sevilla, Spain, 41013
Valencia, Spain, 46014
Sweden
Linköping, Sweden, 581 85
Uppsala, Sweden, 751 85
Switzerland
Basel, Basel-Stadt, Switzerland, 4031
Chur, Graubünden, Switzerland, 7000
Bern, Switzerland, 3010
Genève, Switzerland, 1211
Zürich, Switzerland, 8091
United Kingdom
Leicester, Leicestershire, United Kingdom, LE1 5WW
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01538680     History of Changes
Other Study ID Numbers: 15967, 2011-005836-25
Study First Received: February 21, 2012
Last Updated: July 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Canadian Institutes of Health Research
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Direction Générale de la Santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Netherlands: Dutch Health Care Inspectorate
Poland: The Central Register of Clinical Trials
Spain: Ministry of Health and Consumption
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Greece: Ministry of Health and Welfare
Mexico: Federal Commission for Protection Against Health Risks
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
Ireland: Irish Medicines Board
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 20, 2014