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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Alkotinib

• Registration Number: NCT03607188
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-31
• Study Start: 2018-10-18
• Primary Completion: 2022-10-17
• Study Completion: 2022-10-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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 10^9/L

   2. Platelets ≥75 x 10^9/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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ZG0418 300mg QD	Alkotinib	ZG0418 300mg/day,oral
ZG0418 400mg QD	Alkotinib	ZG0418 400mg/day,oral
ZG0418 600mg QD	Alkotinib	ZG0418 600mg/day,oral
ZG0418 500mg QD	Alkotinib	ZG0418 500mg/day,oral
ZG0418 200mg QD	Alkotinib	ZG0418 200mg/day,oral

Primary Outcome Measures

Name	Time	Method
MTD	Day1 to Day25	Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib

Trial Locations

Locations (1)

Shanghai Eastern Hospital; 🇨🇳 Shanghai, Shanghai, China