A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib

Non-small Cell Lung Cancer(NSCLC) Clinical Trial

Official title:
A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.

Clinical Trial Description

This is a 3-part phase 1-2 study in patients with anaplastic lymphoma kinase (ALK) + or other potentially crizotinib-sensitive NSCLC who have been receiving crizotinib. Part A is a single-arm, Phase 1, open-label, dose escalation design in patients with NSCLC who have already been receiving crizotinib for at least 8 weeks and continue to tolerate therapy. Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the maximum tolerated dose established in Part A. Part C is an open-label, randomized, Phase 2, Simon's 2 stage design evaluating single agent AT13387 or combination AT13387 + crizotinib at the MTD established in Part A in patients who progressed on crizotinib at any time. ;

Study Design

Related Conditions & MeSH terms

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Non-small Cell Lung Cancer(NSCLC)

Clinical Trial Details

NCT number	NCT01712217
Study type	Interventional
Source	Astex Pharmaceuticals
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	October 2012
Completion date	May 16, 2017

View Details

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