SNPMiner Trials by Shray Alag

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Report for Clinical Trial NCT01436656

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma

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.

NCT01436656 Melanoma and Metastatic Colorectal Cancer
HPO:Cutaneous melanoma Melanoma

1 Interventions

Name: LGX818

Type: Drug
Group Labels: 2

LGX818 - Dose Expansion at MTD or RP2D LGX818 - Dose escalation

Primary Outcomes

Measure: Incidence of Dose Limiting Toxicities

Time: Approximately every 8 weeks (up to 2 years)

Secondary Outcomes

Measure: Number and nature of Adverse events and clinical activity

Time: Approximately 3 years

Description: LGX818 Plasma concentration

Measure: Pharmacokinetic profile of LGX818

Time: Approximately 2 years

Description: This includes duration of response, time to response, progression free survival and overall survival.

Measure: Tumor response per RECIST

Time: Approximately 3 years

Description: Baseline molecular status (mutation/ amplification/ expression) in tumor tissue of potential predictive markers

Measure: Baseline molecular status

Time: Approximately 3 years

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment

There is one SNP


1 V600E

2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation. --- V600E ---

HPO Nodes