To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.
The study is a randomized, double-blind phase 1 trial including 2 sequential parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part. SAD and MAD are dose-escalated tolerant study designing. The aims of the study as below: 1. Evaluating the safety and tolerance of ZG0418 in ALK+ NSCLC. 2. Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK+ NSCLCJaktinib. 3. Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK+ NSCLC. 4. Analysis the metabolites of ZG0418
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD
Shanghai Eastern Hospital
Shanghai, Shanghai Municipality, China
MTD
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib
Time frame: Day1 to Day25
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