TriangleNCT02959619 · CITED IN SOURCE DOCUMENTS
Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1
- Status at capture
- COMPLETED
- Registry last update
- 2023-08-21
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
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Escalating dose of ensartinib was orally given once er day
- intervention Names
- Drug: Ensartinib
- label
- Ensartinib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Ensartinib
- description
- Oral ensartinib was given daily at escalating doses in a 28-day cycle
- name
- Ensartinib
- other Names
- X-396
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 48
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Maximum Tolerated Dose
- time Frame
- 12 months
- secondary Outcomes
- description
- To characterize the preliminary pharmacokinetics of single-agent ensartinib
- measure
- Peak Plasma Concentration (Cmax)
- time Frame
- 12 months
- description
- To characterize the preliminary pharmacokinetics of single-agent ensartinib
- measure
- Area under the plasma concentration versus time curve (AUC)
- time Frame
- 12 months
- description
- To characterize the preliminary pharmacokinetics of single-agent ensartinib
- measure
- Half-life time
- time Frame
- 12 months
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Ma Y, Pan H, Liu Y, Zhang Y, Hong S, Huang J, Weng S, Yang Y, Fang W, Huang Y, Xiao S, Wang T, Ding L, Cui L, Zhang L, Zhao H. Ensartinib in advanced ALK-positive non-small cell lung cancer: a multicenter, open-label, two-staged, phase 1 trial. J Thorac Dis. 2022 Dec;14(12):4751-4762. doi: 10.21037/jtd-22-1606.
- pmid
- 36647478
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- NCT02959619
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- clinical indication matching status
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- link basis
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- nct id
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- occurrences
- context exact
- r metastatic ALK-positive NSCLC in the following trials: eXALT3 Study (N=143) [see Clinical Studies ( 14.1 ) ], Study 101 (NCT01625234, N=98), Study BTP-28311 (NCT02959619, N=35), and Study BTP-42322 (NCT03215693, N=182). Patients received ENSACOVE 225 mg orally once daily, with or without food, until disease progression or unacc
- end
- 1996
- exact text
- NCT02959619
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Preserved source evidence · Not medical advice