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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZG0418 200mg QD | Experimental | ZG0418 200mg/day,oral |
|
| ZG0418 300mg QD | Experimental | ZG0418 300mg/day,oral |
|
| ZG0418 400mg QD | Experimental | ZG0418 400mg/day,oral |
|
| ZG0418 500mg QD | Experimental | ZG0418 500mg/day,oral |
|
| ZG0418 600mg QD | Experimental | ZG0418 600mg/day,oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alkotinib | Drug | Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD | Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib | Day1 to Day25 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Li, Doctor | Shanghai Eastern Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eastern Hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |