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

Non-small Cell Lung Cancer Clinical Trial

— NSCLC  

Official title:

A Phase I Tolerance, Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Positive /ROS1 Positive NSCLC and Previously Treated With Chemotherapy or Crizotinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607188
• Other study ID #: ZGALK001
• Status: Completed
• Phase: Phase 1
• Start date: October 18, 2018
• Est. completion date: October 17, 2022

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 17, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Eastern Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD	Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib	Day1 to Day25