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

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02959619
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
69.8
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 6, 2017
Actual Primary Completion Date :
Oct 31, 2019
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ensartinib

Escalating dose of ensartinib was orally given once er day

Drug: Ensartinib
Oral ensartinib was given daily at escalating doses in a 28-day cycle
Other Names:
  • X-396

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose [12 months]

    Secondary Outcome Measures

    1. Peak Plasma Concentration (Cmax) [12 months]

      To characterize the preliminary pharmacokinetics of single-agent ensartinib

    2. Area under the plasma concentration versus time curve (AUC) [12 months]

      To characterize the preliminary pharmacokinetics of single-agent ensartinib

    3. Half-life time [12 months]

      To characterize the preliminary pharmacokinetics of single-agent ensartinib

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun yat-sen Univerisity Cancer Center Guanzhou Guangdong China 510060

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Study Chair: Li Zhang, MD, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02959619
    Other Study ID Numbers:
    • BTP-28311
    First Posted:
    Nov 9, 2016
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Ensartinib

    Study Results

    No Results Posted as of Nov 24, 2021