Spots Global Cancer Trial Database for Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759

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Trial Identification

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

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

Study ID: NCT03360929

Conditions

Non Small Cell Lung Cancer

Interventions

AZD3759

Study Description

Brief 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.

Detailed 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.