Overview

This trial is active, not recruiting.

Condition melanoma and metastatic colorectal cancer
Treatment lgx818
Phase phase 1
Target RAF
Sponsor Array BioPharma
Start date September 2011
End date October 2012
Trial size 107 participants
Trial identifier NCT01436656, 2011-000556-42, CLGX818X2101

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
lgx818
(Experimental)
lgx818

Primary Outcomes

Measure
Incidence of Dose Limiting Toxicities
time frame: Approximately every 8 weeks (up to 2 years)

Secondary Outcomes

Measure
Number and nature of Adverse events and clinical activity
time frame: Approximately 3 years
Pharmacokinetic profile of LGX818
time frame: Approximately 2 years
Tumor response per RECIST
time frame: Approximately 3 years
Baseline molecular status
time frame: Approximately 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: For the dose escalation phase: 1. 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. 2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation. 3. Evidence of measurable disease Exclusion Criteria: 1. Previous therapy with a MEK inhibitor. 2. Symptomatic or untreated leptomeningeal disease. 3. 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. 4. Known acute or chronic pancreatitis. 5. Clinically significant cardiac disease 6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818 7. 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. 8. 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). 9. History of thromboembolic or cerebrovascular events within the last 6 months Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Array BioPharma.