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

Betta Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Non-Small Cell Lung Cancer Metastatic

Solid Tumor

Treatments

Drug: Ensartinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02959619

BTP-28311

Details and patient eligibility

About

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

Full 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No 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