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
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
Drug | Synonyms | Arms |
---|
Ensartinib | X-396 | Ensartinib |
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
Name | Type | Description | Interventions |
---|
Ensartinib | Experimental | Escalating dose of ensartinib was orally given once er day | |
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: | Unknown status |
Lead Sponsor: | Betta Pharmaceuticals Co., Ltd. |
Last Updated
July 24, 2019