Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK

Study Overview
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Brief Summary
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This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer

Detailed Description
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The initial purpose of the study is to determine the largest amount of ensartinib that can be safely given to humans. An expansion phase will be conducted to assess the preliminary anti-tumor activity in ALK-positive non-small cell lung cancer once the recommended Phase 2 dose has been established.

Official Title
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Phase 1, Dose-escalating, Open-label Study of Ensartinib, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer

Conditions
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Solid Tumor, Non-Small Cell Lung Cancer Metastatic

Intervention / Treatment
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* Drug: Ensartinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations positive by FISH or IHC Eastern Cooperative Group ECOG) Performance Status score of 0 or 1 Adequate organ system function Male patients willing to use adequate contraceptive measures; female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures Measurable disease per RECIST Willingness and ability to comply with the trial and follow-up procedures Written informed consents are required to indicate that the patients are aware of the investigational nature of the study Exclusion Criteria: Current use of anticancer therapy. Use of an investigational drug within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of ensartinib Any major surgery, radiotherapy, or immunotherapy within the last 21 days. Chemotherapy regimens with delayed toxicity within the last 4 weeks. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks. Prior stem cell transplant Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib or to the active ingredient of ensartinib Prior use of ALK TKIs with the exception of crizotinib Primary CNS tumors or meningeal metastasis Pregnant or breastfeeding female Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib Clinically significant cardiovascular disease. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol Concurrent condition evaluated by investigator would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ensartinib<br>Escalating dose of ensartinib was orally given once er day | Drug: Ensartinib<br>* Oral ensartinib was given daily at escalating doses in a 28-day cycle<br>* Other names: X-396;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | To characterize the preliminary pharmacokinetics of single-agent ensartinib | 12 months | 
| Area under the plasma concentration versus time curve (AUC) | To characterize the preliminary pharmacokinetics of single-agent ensartinib | 12 months | 
| Half-life time | To characterize the preliminary pharmacokinetics of single-agent ensartinib | 12 months |