NCT02959619

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 6, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2020

Completed
Last Updated

August 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

November 6, 2016

Last Update Submit

August 15, 2023

Conditions

Solid TumorNon-Small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    12 months

Secondary Outcomes (3)

  • Peak Plasma Concentration (Cmax)

    12 months

  • Area under the plasma concentration versus time curve (AUC)

    12 months

  • Half-life time

    12 months

Study Arms (1)

Ensartinib

EXPERIMENTAL

Escalating dose of ensartinib was orally given once er day

Drug: Ensartinib

Interventions

EnsartinibDRUG

Oral ensartinib was given daily at escalating doses in a 28-day cycle

Also known as: X-396
Ensartinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun yat-sen Univerisity Cancer Center

Guanzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • 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: 36647478DERIVED

MeSH Terms

Interventions

ensartinib

Study Officials

  • Li Zhang, MD

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2016

First Posted

November 9, 2016

Study Start

March 6, 2017

Primary Completion

October 31, 2019

Study Completion

April 23, 2020

Last Updated

August 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)