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Report for Clinical Trial NCT00522145

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Study of XL647 in Subjects With Non-Small Cell Lung Cancer Who Have Progressed After Responding to Treatment With Either Gefitinib or Erlotinib

The purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR and VEGFR2) XL647 in subjects with NSCLC who have progressed after responding to treatment with either erlotinib or gefitinib.

NCT00522145 Carcinoma, Non-Small-Cell Lung
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: XL647

Description: Daily dosing as a single oral agent at a dose of 300 mg supplied as 50-mg tablets

Type: Drug

Group 1


Primary Outcomes

Measure: Determine the best confirmed response rate

Time: Inclusion until disease progression

Secondary Outcomes

Measure: Safety and tolerability of XL647 administered daily

Time: First treatment until 30 day post last treatment

Measure: Progression-free survival, duration of response, and overall survival

Time: Incusion until disease progression

Measure: Further characterize the pharmacokinetic (PK) parameters

Time: Every 8 weeks after Day 57 until disease progression

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

- Subjects must have: 1. documented (radiological or clinical) progressive disease (PD) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression OR 2. a documented T790M EGFR mutation - Measurable disease defined according to RECIST - ECOG performance status of 0 or 1. - Sexually active subjects must use an accepted method of contraception during the course of the study. --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1