SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03446417

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of ZN-e4 in Patients With Advanced Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor (EGFR) Mutations

This is a Phase I, open-label, multicenter, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-e4 administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations who have progressed following treatment with an EGFR inhibitor.

NCT03446417 Carcinoma, Non-Small-Cell Lung
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: ZN-e4

Description: Oral dose, tablet, daily dosing

Type: Drug

Dose escalation Dose expansion


Primary Outcomes

Measure: Observed dose limiting toxicities

Time: 1 Cycle (21 days)

Secondary Outcomes

Measure: Safety and tolerability as measured by incidence of treatment emergent adverse events

Time: Through study completion, approximately 2 years

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There is one SNP

SNPs


1 T790M

Inclusion Criteria: - Age ≥ 18 years - Histologically or cytologically confirmed metastatic or advanced inoperable diagnosis of non-small cell lung cancer (NSCLC) - Radiographic documentation of disease progression while on previous continuous treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) - All subjects must fulfill one of the following: 1. Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity OR 2. Must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria followed by systemic objective progression while on continuous treatment with EGFR TKI - Dose Expansion cohort(s): subjects in the dose expansion cohorts must also have confirmation of tumor T790M mutation status (confirmed positive) by cobas® EGFR Mutation Test v2 from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) plasma sample taken after disease progression on the most recent treatment regimen (EGFR TKI or chemotherapy or other therapy). --- T790M ---

ipilimumab, nivolumab, pembrolizumab, atezolizumab) within 6 months of cycle 1 day 1 - Known intermediate or strong CYP3A4 or CYP2C8 inhibitors or inducers within 14 days prior to first dose of study treatment Inclusion Criteria: - Age ≥ 18 years - Histologically or cytologically confirmed metastatic or advanced inoperable diagnosis of non-small cell lung cancer (NSCLC) - Radiographic documentation of disease progression while on previous continuous treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) - All subjects must fulfill one of the following: 1. Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity OR 2. Must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria followed by systemic objective progression while on continuous treatment with EGFR TKI - Dose Expansion cohort(s): subjects in the dose expansion cohorts must also have confirmation of tumor T790M mutation status (confirmed positive) by cobas® EGFR Mutation Test v2 from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) plasma sample taken after disease progression on the most recent treatment regimen (EGFR TKI or chemotherapy or other therapy). --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1