Spots Global Cancer Trial Database for A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma
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Trial Identification
Brief Title: A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma
Official Title: A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma
Study ID: NCT01436656
Interventions
Study Description
Brief Summary: CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Western Sydney Local Health District, Westmead, New South Wales, Australia
Westmead Hospital- Redbank Rd, Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
EDOG - Institut Claudia Regaud - PPDS, Toulouse, Haute-garonne, France
EDOG - Institut Claudius Regaud - PPDS, Toulouse, Haute-garonne, France
Institut Gustave Roussy, Villejuif, ILE DE France - VAL DE Marne (94), France
Institut Gustave Roussy, Villejuif, VAL DE Marne, France
Institut Gustave Roussy, Villejuif Cedex, Val-de-marne, France
Institut Gustave Roussy, Villejuif, Val-de-marne, France
Institut Gustave Roussy, Villejuif, , France
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Oslo Myeloma Center - PPDS, Oslo, , Norway
Hospital Clinic de Barcelona, Badalona, , Spain
Hospital General Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
Hospital Universitario HM Sanchinarro_CIOCC, Madrid, , Spain
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC, Madrid, , Spain
Kantonsspital Graubünden, Chur, Graubünden (DE), Switzerland
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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