NCT01625234 · OUTCOME

Maximum Tolerated Dose

Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer · Source last updated 2026-04-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: mg
Interval / dispersion: Not reported
Time frame: 28 Days

What was measured

To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent.

Analysis population: Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1. For Phase study, patients must have NSCLC with ALK genomic alterations.

Groups in this outcome

Phase I/II X:396 Ensartinib

All patients treated in the escalating doses from 25 mg -250 mg

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase I/II X:396 Ensartinib	131

Reported measurements

Source class 1

Values in mg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I/II X:396 Ensartinib	250	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
250

denoms

counts
group Id
OG000
value
131
units
Participants

description

To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent.

groups

description
All patients treated in the escalating doses from 25 mg -250 mg
id
OG000
title
Phase I/II X:396 Ensartinib

param Type

NUMBER

population Description

Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1. For Phase study, patients must have NSCLC with ALK genomic alterations.

reporting Status

POSTED

time Frame

28 Days

title

Maximum Tolerated Dose

type

PRIMARY

unit Of Measure

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice