Clinical Trials /

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

NCT02959619

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: BTP-28311
  • NCT ID: NCT02959619

Conditions

  • Solid Tumor
  • Non-Small Cell Lung Cancer Metastatic

Interventions

DrugSynonymsArms
EnsartinibX-396Ensartinib

Purpose

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

      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.
    

Trial Arms

NameTypeDescriptionInterventions
EnsartinibExperimentalEscalating dose of ensartinib was orally given once er day
  • Ensartinib

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose
Time Frame:12 months
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Betta Pharmaceuticals Co.,Ltd.

Last Updated

April 25, 2017