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

May 27, 2019 updated by: Bayer

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
      • St Leonards, New South Wales, Australia, 2065
    • South Australia
      • Woodville South, South Australia, Australia, 5011
    • Victoria
      • Footscray, Victoria, Australia, 3011
      • Parkville, Victoria, Australia, 3050
  • Austria
      • Wien, Austria, 1090
    • Oberösterreich
      • Wels, Oberösterreich, Austria, 4600
    • Steiermark
      • Graz, Steiermark, Austria, 8036
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Bruxelles - Brussel, Belgium, 1200
      • Bruxelles - Brussel, Belgium, 1000
      • Edegem, Belgium, 2650
      • Leuven, Belgium, 3000
      • Roeselare, Belgium, 8800
  • Canada
      • Quebec, Canada, G1R 2J6
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2N1
      • Oshawa, Ontario, Canada, L1G 2B9
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
  • Czechia
      • Brno, Czechia, 65 653
      • Praha, Czechia, 18081
  • Denmark
      • Aarhus C, Denmark, 8000
      • Copenhagen, Denmark, 2100
  • Finland
      • HUS, Finland, 00029
      • Helsinki, Finland, 00180
  • 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, 75651
      • Paris, France, 75571
      • Paris Cedex 15, France, 75908
      • Reims Cedex, France, 51092
      • Saint Herblain, France, 44805
      • Strasbourg Cedex, France, 67085
      • Toulouse, France, 31059
  • Germany
      • Berlin, Germany, 12200
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • 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
    • Bayern
      • München, Bayern, Germany, 81925
      • München, Bayern, Germany, 81377
      • München, Bayern, Germany, 81737
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
      • Oldenburg, Niedersachsen, Germany, 26133
    • Nordrhein-Westfalen
      • 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
    • Rheinland-Pfalz
      • Trier, Rheinland-Pfalz, Germany, 54290
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
      • Magdeburg, Sachsen-Anhalt, Germany, 39104
  • 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, 3109601
      • Jerusalem, Israel, 9112001
      • Petah Tikva, Israel, 4941492
      • Tel Aviv, Israel, 6423906
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41124
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
    • Lazio
      • Roma, Lazio, Italy, 00168
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Brescia, Lombardia, Italy, 25124
      • Milano, Lombardia, Italy, 20133
      • Milano, Lombardia, Italy, 20089
      • Milano, Lombardia, Italy, 20162
    • Marche
      • Ancona, Marche, Italy, 60126
    • Puglia
      • Foggia, Puglia, Italy, 71013
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
    • Toscana
      • Firenze, Toscana, Italy, 50134
      • Pisa, Toscana, Italy, 56126
    • Veneto
      • Padova, Veneto, Italy, 35128
  • Mexico
      • Aguascalientes, Mexico, 20230
      • Oaxaca, Mexico, 68000
      • Toluca, Mexico, 50180
      • Veracruz, Mexico, 91910
    • Distrito Federal
      • Mexico, D.F., Distrito Federal, Mexico, 01120
      • Mexico, D.F., Distrito Federal, Mexico, 14050
      • México, Distrito Federal, Mexico, 14080
      • México, D.F., Distrito Federal, Mexico, 14080
    • Guanajuato
      • Irapuato, Guanajuato, Mexico, 36500
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Amsterdam, Netherlands, 1081 HV
      • 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, 119991
      • Moscow, Russian Federation, 115478
      • Obninsk, Russian Federation, 249036
      • Orenburg, Russian Federation, 460021
      • St. Petersburg, Russian Federation, 197022
      • St. Petersburg, Russian Federation, 197758
  • Spain
      • A Coruña, Spain, 15006
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Málaga, Spain, 29010
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46014
    • Andalucía
      • Córdoba, Andalucía, Spain, 14004
    • Barcelona
      • Badalona (Barcelona), Barcelona, Spain, 08916
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Sabadell, Barcelona, Spain, 08208
    • Cantabria
      • Santander, Cantabria, Spain, 39008
  • Sweden
      • Linköping, Sweden, 581 85
      • Uppsala, Sweden, 751 85
  • Switzerland
      • Bern, Switzerland, 3010
      • Genève, Switzerland, 1205
      • Zürich, Switzerland, 8091
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
    • Graubünden
      • Chur, Graubünden, Switzerland, 7000
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
  • 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
      • Santa Maria, California, United States, 93454
    • Colorado
      • Denver, Colorado, United States, 80218
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • 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
    • Georgia
      • Atlanta, Georgia, United States, 30318
      • Columbus, Georgia, United States, 31904
      • Savannah, Georgia, United States, 31405
    • Illinois
      • Park Ridge, Illinois, United States, 60068
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
      • Sioux City, Iowa, United States, 51101
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
      • Shreveport, Louisiana, United States, 71130
    • Maine
      • Brewer, Maine, United States, 04412
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-5450
      • Burlington, Massachusetts, United States, 01805
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Mississippi
      • Jackson, Mississippi, United States, 39202
    • Missouri
      • Jefferson City, Missouri, United States, 65109
    • Nebraska
      • Omaha, Nebraska, United States, 68106
    • Nevada
      • Las Vegas, Nevada, United States, 89169
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New York
      • Bronx, New York, United States, 10461
      • 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
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
      • Winston-Salem, North Carolina, United States, 27157
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
      • Toledo, Ohio, United States, 43617
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19111-2497
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
    • South Carolina
      • Charleston, South Carolina, United States, 29414
      • Sumter, South Carolina, United States, 29150
    • Tennessee
      • Memphis, Tennessee, United States, 38120
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Dallas, Texas, United States, 75390-9110
      • Temple, Texas, United States, 76508
    • Virginia
      • Portsmouth, Virginia, United States, 23704
      • Richmond, Virginia, United States, 23298-0037
    • Washington
      • Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (ESTIMATE)

February 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15967
  • 2011-005836-25 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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