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

Primary Purpose

Solid Tumor, Non-Small Cell Lung Cancer Metastatic

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ensartinib
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun yat-sen Univerisity Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ensartinib

Arm Description

Escalating dose of ensartinib was orally given once er day

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose

Secondary Outcome Measures

Peak Plasma Concentration (Cmax)
To characterize the preliminary pharmacokinetics of single-agent ensartinib
Area under the plasma concentration versus time curve (AUC)
To characterize the preliminary pharmacokinetics of single-agent ensartinib
Half-life time
To characterize the preliminary pharmacokinetics of single-agent ensartinib

Full Information

First Posted
November 6, 2016
Last Updated
August 15, 2023
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02959619
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
April 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Non-Small Cell Lung Cancer Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ensartinib
Arm Type
Experimental
Arm Description
Escalating dose of ensartinib was orally given once er day
Intervention Type
Drug
Intervention Name(s)
Ensartinib
Other Intervention Name(s)
X-396
Intervention Description
Oral ensartinib was given daily at escalating doses in a 28-day cycle
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
To characterize the preliminary pharmacokinetics of single-agent ensartinib
Time Frame
12 months
Title
Area under the plasma concentration versus time curve (AUC)
Description
To characterize the preliminary pharmacokinetics of single-agent ensartinib
Time Frame
12 months
Title
Half-life time
Description
To characterize the preliminary pharmacokinetics of single-agent ensartinib
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun yat-sen Univerisity Cancer Center
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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