Back to resultsStudy of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Alkotinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2. (see Appendix A)
- Life expectancy of at least 12 weeks.
- Ability to swallow and retain oral medication.
Adequate organ system function, defined as follows:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelets ≥75 x 109/L
- Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level
- Total bilirubin ≤1.5 times the upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.
- Creatinine 1.5 x ULN.
- Brain metastases allowed if asymptomatic at study baseline.
- Patients must have measurable disease per RECIST v. 1.1.
Exclusion Criteria:
- chemotherapy, radiation therapy, immunotherapy within 4 weeks.
- Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
- uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.
Sites / Locations
- Shanghai Eastern HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
ZG0418 200mg QD
ZG0418 300mg QD
ZG0418 400mg QD
ZG0418 500mg QD
ZG0418 600mg QD
Arm Description
ZG0418 200mg/day,oral
ZG0418 300mg/day,oral
ZG0418 400mg/day,oral
ZG0418 500mg/day,oral
ZG0418 600mg/day,oral
Outcomes
Primary Outcome Measures
MTD
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib
Secondary Outcome Measures
Full Information
NCT ID
NCT03607188
First Posted
July 23, 2018
Last Updated
March 30, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03607188
Brief Title
Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
Evaluating the safety and tolerance of ZG0418 in ALK+ NSCLC.
Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK+ NSCLCJaktinib.
Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK+ NSCLC.
Analysis the metabolites of ZG0418
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ZG0418 200mg QD
Arm Type
Experimental
Arm Description
ZG0418 200mg/day,oral
Arm Title
ZG0418 300mg QD
Arm Type
Experimental
Arm Description
ZG0418 300mg/day,oral
Arm Title
ZG0418 400mg QD
Arm Type
Experimental
Arm Description
ZG0418 400mg/day,oral
Arm Title
ZG0418 500mg QD
Arm Type
Experimental
Arm Description
ZG0418 500mg/day,oral
Arm Title
ZG0418 600mg QD
Arm Type
Experimental
Arm Description
ZG0418 600mg/day,oral
Intervention Type
Drug
Intervention Name(s)
Alkotinib
Other Intervention Name(s)
ZG0418
Intervention Description
Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD
Primary Outcome Measure Information:
Title
MTD
Description
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib
Time Frame
Day1 to Day25
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
Life expectancy of at least 12 weeks.
Ability to swallow and retain oral medication.
Adequate organ system function, defined as follows:
Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
Platelets ≥75 x 10^9/L
Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level
Total bilirubin ≤1.5 times the upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.
Creatinine 1.5 x ULN.
Brain metastases allowed if asymptomatic at study baseline.
Patients must have measurable disease per RECIST v. 1.1.
Exclusion Criteria:
chemotherapy, radiation therapy, immunotherapy within 4 weeks.
Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Shi, Master
Phone
13817565470
Email
50709035@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Guo, Doctor
Phone
13501678472
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, Doctor
Organizational Affiliation
Shanghai Eastern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Eastern Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Guo, Doctor
Phone
13501678472
12. IPD Sharing Statement
Learn more about this trial
Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
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