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Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759

Non Small Cell Lung Cancer Clinical Trial

Official title:
A Phase I/II, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759 in Chinese Patients With EGFRm+ NSCLC With Central Nervous System (CNS) Metastases

Clinical Trial Summary

This is a multi-center, open-label, dose escalation and phase I/II study, consisting of dose escalation in Part A and phase II study in Part B.

Clinical Trial Description

Dose escalation and dose expansion to determine safety and tolerability of AZD3759, and explore RP2D in treatment of Chinese patients with EGFRm+ NSCLC with CNS metastasis. Two dose cohorts include: 150 and 250mg twice daily. Subjects will receive multiple doses of AZD3759 for consecutively 21 days each cycle. Dose escalation is planned to be performed in a single center, and dose expansion in multiple centers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03360929
Study type Interventional
Source LYZZ Alpha Holding Ltd
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 30, 2017
Completion date November 13, 2020
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