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Treating Patients With Melanoma and ALK Alterations With Ensartinib

NCT03420508 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-13

No results posted yet for this study

Summary

The purpose of this study is to test the effects of the study drug, ensartinib, on the patient and the cancer. Ensartinib is a new, investigational type of treatment for melanoma with a particular type of abnormality.

Conditions

Interventions

DRUG

Ensartinib

Ensartinib will be given at a dose of 225mg daily in the form of 100mg and 25mg capsules. Patients will receive treatment continuously in 28 day cycles. Patients will then have the same tumor specimen biopsied again at day 15. Treatment will continue until disease progression, unacceptable toxicity, or patient choice to discontinue therapy.

DIAGNOSTIC_TEST

ALKATI by Customized Nanostring Assay

a custom chip with probes targeting the ATI site in ALK, providing a reproducible, quantitative measure of ALKATI

Sponsors & Collaborators

Principal Investigators

  • Alexander Shoushtari · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03420508 on ClinicalTrials.gov