A Phase I Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer

Overview

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.

Full Title of Study: “A Phase I Tolerance, Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Postive /ROS1 Positve NSCLC and Previously Treated With Chemotherapy or Crizotinib”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2020

Detailed Description

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

Interventions

  • Drug: Alkotinib
    • Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD

Arms, Groups and Cohorts

  • Experimental: ZG0418 200mg QD
    • ZG0418 200mg/day,oral
  • Experimental: ZG0418 300mg QD
    • ZG0418 300mg/day,oral
  • Experimental: ZG0418 400mg QD
    • ZG0418 400mg/day,oral
  • Experimental: ZG0418 500mg QD
    • ZG0418 500mg/day,oral
  • Experimental: ZG0418 600mg QD
    • ZG0418 600mg/day,oral

Clinical Trial Outcome Measures

Primary Measures

  • MTD
    • Time Frame: Day1 to Day25
    • Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkatinib

Participating in This Clinical Trial

Inclusion Criteria

1. Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib

2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2. (see Appendix A)

3. Life expectancy of at least 12 weeks.

4. Ability to swallow and retain oral medication.

5. Adequate organ system function, defined as follows:

1. Absolute neutrophil count (ANC) ≥1.5 x 109/L

2. Platelets ≥75 x 109/L

3. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level

4. Total bilirubin ≤1.5 times the upper limit of normal (ULN)

5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.

6. Creatinine 1.5 x ULN.

6. Brain metastases allowed if asymptomatic at study baseline.

7. Patients must have measurable disease per RECIST v. 1.1.

Exclusion Criteria

1. chemotherapy, radiation therapy, immunotherapy within 4 weeks.

2. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.

3. uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Suzhou Zelgen Biopharmaceuticals Co.,Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jin Li, Doctor, Principal Investigator, Shanghai Eastern Hospital
  • Overall Contact(s)
    • Yan Shi, Master, 13817565470, 50709035@163.com

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