A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

Completed · Phase 1

Conditions studied: Melanoma and Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT01436656

Run by

Pfizer

People needed

107

Starts

2011-09-05

Expected to finish

2022-11-07

Last updated by the study team

2024-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For the dose escalation phase:
• Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.
• Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
• Evidence of measurable disease

You may not qualify if…

• Previous therapy with a MEK inhibitor.
• Symptomatic or untreated leptomeningeal disease.
• Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.
• Known acute or chronic pancreatitis.
• Clinically significant cardiac disease
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818
• Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
• History of thromboembolic or cerebrovascular events within the last 6 months
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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 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, 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
• Universität Zürich — Zurich, Switzerland

Full record on ClinicalTrials.gov

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