Last updated 30 days ago

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

400 patients around the world
Available in United States, Spain, Chile, Argentina
Seagen Inc.
13Research sites
400Patients around the world

This study is for people with

Colorectal cancer
Colon cancer
Rectal cancer

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory. If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
HER2+ disease as determined by a tissue based assay performed at a central laboratory.
Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
Radiographically measurable disease per RECIST v1.1 with: At least one site of disease that is measurable and that has not been previously irradiated, or If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following: No evidence of brain metastases, Previously treated brain metastases which are asymptomatic
Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization. Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
Previous treatment with anti-HER2 therapy
Ongoing Grade 3 or higher neuropathy
GI perforation within 12 months of enrollment

Sites

Hospital Británico de Buenos Aires - CABA
Hospital Británico de Buenos Aires - CABA
Recruiting
Perdriel 74, CABA, Buenos Aires
Centro Médico Privado CEMAIC - Córdoba
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Monseñor Pablo Cabrera 2941, Córdoba
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Av. Crámer 1180, CABA, Buenos Aires
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Italia 428, Rosario - Santa Fe
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Paraná 560, Córdoba
Hospital Nossa Senhora da Conceição
Recruiting
Av. Francisco Trein, 596 – 2º andar - Bairro: Cristo Redentor - CEP 91350-200 - Porto Alegre
Oncocentro APYS - Valparaíso
Recruiting
Avenida La Marina 1702, Viña del Mar, Valparaíso
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
Antonio Varas 517, 7500653 Providencia, Región Metropolitana
Hospital Universitario La Paz
Recruiting
Madrid, 28046
Hospital Universitario 12 de Octubre
Recruiting
Av. de Córdoba, s/n, 28041 Madrid
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