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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
MeSH: Melanoma
HPO: Cutaneous melanoma Melanoma

1 Interventions

Name: LGX818

Type: Drug

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

SNPs


1 V600E

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



HPO Nodes


HPO:
Cutaneous melanoma
Genes 15
HRAS MITF CDKN2A BRAF NRAS NRAS WRN CDKN2A CXCR4 BAP1 POLH CDK4 ERCC3 XPC MC1R
Melanoma
Genes 98
MGMT NRAS POT1 NRAS XPA CTSC BRCA1 SDHC ERCC4 CXCR4 RAD51C CDKN2B ERCC3 XPC PALLD ERCC2 ERCC2 CHEK2 CDKN2A RAD51D GNAQ SDHD KRAS MBTPS2 BAP1 BAP1 CYSLTR2 RNF43 BAP1 CDKN2A PTPN11 CDK4 BRCA2 ERCC3 MITF TERF2IP ERCC4 CHEK2 BRCA1 TRPV3 POT1 OCA2 TERT CDKN2A AKT1 CDKN2A SF3B1 ERCC6 ERCC5 ERCC5 MDM2 BRCA2 BAP1 GNA11 ACD BRIP1 HRAS MRE11 BRAF TYR TP53 KLLN SEC23B PTEN PIK3CA XPA PERP MITF RAF1 BRAF POLH TP53 BARD1 NRAS SMAD4 RAD50 DDB2 ERCC2 NBN TERT MC1R SLC45A2 WRN PALB2 DDB2 PALB2 CDKN2A SDHB MC1R RAD51 TP53 XPC ERCC3 PTEN CDKN2A POLH CDK4 MC1R