Melanoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

93

Study ID:

NCT01436656

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 16 Locations for this study

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H Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Western Sydney Local Health District
Westmead New South Wales, 2145, Australia
Westmead Hospital- Redbank Rd
Westmead New South Wales, 2145, Australia
Peter MacCallum Cancer Centre
East Melbourne Victoria, 3002, Australia
EDOG - Institut Claudia Regaud - PPDS
Toulouse Haute-garonne, 31059, France
EDOG - Institut Claudius Regaud - PPDS
Toulouse Haute-garonne, 31059, France
Institut Gustave Roussy
Villejuif ILE DE France - VAL DE Marne (94), 94800, France
Institut Gustave Roussy
Villejuif VAL DE Marne, 94800, France
Institut Gustave Roussy
Villejuif Cedex Val-de-marne, 94805, France
Institut Gustave Roussy
Villejuif Val-de-marne, 94805, France
Institut Gustave Roussy
Villejuif , 94805, France
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
Oslo Myeloma Center - PPDS
Oslo , 00424, Norway
Hospital Clinic de Barcelona
Badalona , 08036, Spain
Hospital General Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona , 08035, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona , 8035, Spain
Hospital Universitario HM Sanchinarro_CIOCC
Madrid , 28050, Spain
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC
Madrid , 28050, Spain
Kantonsspital Graubünden
Chur Graubünden (DE), 07000, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

93

Study ID:

NCT01436656

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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