Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
NSCLC
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
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 nonsmall-cell-lung-cancer
Started Oct 2018
Typical duration for phase_1 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
October 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2022
CompletedMarch 6, 2024
March 1, 2024
4 years
July 23, 2018
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
MTD
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib
Day1 to Day25
Study Arms (5)
ZG0418 200mg QD
EXPERIMENTALZG0418 200mg/day,oral
ZG0418 300mg QD
EXPERIMENTALZG0418 300mg/day,oral
ZG0418 400mg QD
EXPERIMENTALZG0418 400mg/day,oral
ZG0418 500mg QD
EXPERIMENTALZG0418 500mg/day,oral
ZG0418 600mg QD
EXPERIMENTALZG0418 600mg/day,oral
Interventions
Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Eastern Hospital
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Li, Doctor
Shanghai Eastern Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2018
First Posted
July 31, 2018
Study Start
October 18, 2018
Primary Completion
October 17, 2022
Study Completion
October 17, 2022
Last Updated
March 6, 2024
Record last verified: 2024-03