Phase
Condition
Colorectal Cancer
Metastatic Cancer
Treatment
Encorafenib
ZN-c3
Cetuximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed metastatic Stage IV colorectaladenocarcinoma.
Documented evidence of a BRAF V600E mutation in tumor tissue or blood
Presence of measurable disease per RECIST version 1.1 guidelines.
Disease progression after 1 or 2 previous systemic regimens for metastatic disease
Adequate bone marrow function
Adequate hepatic and renal function
Exclusion
Exclusion Criteria:
Documented clinical disease progression or radiographic disease progression duringthe screening period
Leptomeningeal disease.
Symptomatic brain metastasis.
Presence of acute or chronic pancreatitis.
Unable to swallow, retain, and absorb oral medications.
Clinically significant cardiovascular diseases
Evidence of active noninfectious pneumonitis.
Evidence of active and uncontrolled bacterial or viral infection, within 2 weeksprior to start of any of the study interventions
Participants with known positivity for HIV
Active hepatitis B or hepatitis C infection
Concurrent or previous other malignancy within 2 years of study entry
Has had an allogeneic tissue/solid organ transplant
Pregnant or females of childbearing potential who have a positive β-hCG laboratorytest result within 14 days prior to enrollment or is breastfeeding
Study Design
Connect with a study center
The Queen Elizabeth Hospital
Woodville South, South Australia 5011
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Hämatologie- Onkologie im Zentrum MVZ GmbH
Augsburg, Bayern 86150
GermanySite Not Available
Klinikum der Universität München Großhadern
Muenchen, Bayern 81377
GermanySite Not Available
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Muenchen, Bayern 81737
GermanySite Not Available
Institut für Klinisch Onkologische Forschung
Frankfurt, Hessen 60488
GermanySite Not Available
DRK Kliniken Berlin - Köpenick
Berlin, 12559
GermanySite Not Available
Semmelweis University-Department of Internal Medicine and Oncology
Budapest, 1083
HungarySite Not Available
Clinexpert Kft. Bugat Pal Korhaz
Gyöngyös, 3200
HungarySite Not Available
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, Campania 80131
ItalySite Not Available
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia 71013
ItalySite Not Available
AOUI Verona
Verona, Veneto 37126
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Istituto Europeo di Oncologia
Milano, 20141
ItalySite Not Available
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Kraków, Malopolskie 31-826
PolandSite Not Available
Szpital Uniwersytecki w Krakowie
Kraków, Malopolskie 31-501
PolandSite Not Available
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Mazowieckie 02-034
PolandSite Not Available
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
Opole, Opolskie 45-061
PolandSite Not Available
Parc de Salut Mar - Hospital del Mar
Barcelona, Cataluna 08003
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba, Cordoba 14004
SpainSite Not Available
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat 46009
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28222
SpainSite Not Available
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Merriam, Kansas 66204
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
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