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

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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor; Non-Small Cell Lung Cancer Metastatic
• Intervention / Treatment: Drug: Ensartinib

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Zhang, MD; Phone Number: 13902282893; Email: li-zhang@csco.org.cn

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510060
      • Sun Yat-Sen Univerisity Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Study Chair: Li Zhang, MD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): April 23, 2020

Study Registration Dates

• First Submitted: November 6, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimated): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Ensartinib
• Other Study ID Numbers: BTP-28311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No