Clinical trial NCT01538680: Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
Official title: An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Colorectal Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-02-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
state: California
city: La Jolla
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Aventura
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Park Ridge
country: United States
state: Illinois
city: Cedar Rapids
country: United States
state: Iowa
city: Sioux City
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Brewer
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Jefferson City
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: Bronx
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Portsmouth
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Concord
country: Australia
state: New South Wales
city: St Leonards
country: Australia
state: New South Wales
city: Woodville South
country: Australia
state: South Australia
city: Footscray
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Wels
country: Austria
state: Oberösterreich
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Roeselare
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Mississauga
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Brno
country: Czechia
city: Praha
country: Czechia
city: Aarhus C
country: Denmark
city: Copenhagen
country: Denmark
city: Helsinki
country: Finland
city: HUS
country: Finland
city: Avignon
country: France
city: Bordeaux
country: France
city: CLERMONT-FERRAND Cedex 1
country: France
city: Le Mans Cedex 2
country: France
city: Lille Cedex
country: France
city: Lille Cedex
country: France
city: Marseille
country: France
city: Montpellier Cedex
country: France
city: Nice
country: France
city: Paris Cedex 15
country: France
city: Paris
country: France
city: Paris
country: France
city: Reims Cedex
country: France
city: Saint Herblain
country: France
city: Strasbourg Cedex
country: France
city: Toulouse
country: France
city: Esslingen
country: Germany
state: Baden-Württemberg
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Mannheim
country: Germany
state: Baden-Württemberg
city: Stuttgart
country: Germany
state: Baden-Württemberg
city: Ulm
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Hannover
country: Germany
state: Niedersachsen
city: Oldenburg
country: Germany
state: Niedersachsen
city: Bochum
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Herne
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Leverkusen
country: Germany
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Porta Westfalica
country: Germany
state: Nordrhein-Westfalen
city: Recklinghausen
country: Germany
state: Nordrhein-Westfalen
city: Trier
country: Germany
state: Rheinland-Pfalz
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Heraklion
country: Greece
city: Kifissia / Athens
country: Greece
city: Budapest
country: Hungary
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petah Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Napoli
country: Italy
state: Campania
city: Modena
country: Italy
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: Brescia
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Foggia
country: Italy
state: Puglia
city: Palermo
country: Italy
state: Sicilia
city: Firenze
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Mexico, D.F.
country: Mexico
state: Distrito Federal
city: Mexico, D.F.
country: Mexico
state: Distrito Federal
city: México, D.F.
country: Mexico
state: Distrito Federal
city: México
country: Mexico
state: Distrito Federal
city: Irapuato
country: Mexico
state: Guanajuato
city: Guadalajara
country: Mexico
state: Jalisco
city: Aguascalientes
country: Mexico
city: Oaxaca
country: Mexico
city: Toluca
country: Mexico
city: Veracruz
country: Mexico
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Leiden
country: Netherlands
city: Oslo
country: Norway
city: Bialystok
country: Poland
city: Poznan
country: Poland
city: Coimbra
country: Portugal
city: Porto
country: Portugal
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Córdoba
country: Spain
state: Andalucía
city: Badalona (Barcelona)
country: Spain
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: A Coruña
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Linköping
country: Sweden
city: Uppsala
country: Sweden
city: Basel
country: Switzerland
state: Basel-Stadt
city: Chur
country: Switzerland
state: Graubünden
city: Bern
country: Switzerland
city: Genève
country: Switzerland
city: Zürich
country: Switzerland
city: Leicester
country: United Kingdom
state: Leicestershire
city: Manchester
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.