Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02418000 · OUTCOME

Maximum Tolerated Dose (MTD) of E6201

A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations · Source last updated 2019-03-20

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

Measure
NUMBER
Unit
E6201 MTD (mg/m^2) IV twice weekly
Interval / dispersion
Not reported
Time frame
Up to 6 weeks for each dose cohort

What was measured

Phase 1 (Safety Run-In) was conducted in 5 dose cohorts in up to 30 subjects in a standard 3+3 dose-escalation design to establish an MTD and recommended Phase 2 dose (RP2D). Safety assessed through the monitoring of adverse events (AEs), serious adverse events (SAEs), clinical laboratory parameters (hematology and serum chemistry), vital sign measurements, electrocardiograms (ECGs) and physical examinations.

Analysis population: Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication

Groups in this outcome

All Participants

All study participants who received at least 1 dose of E6201 at 240 or 320 mg/m\^2 IV weekly, or at 160, 240 or 320 mg/m\^2 IV twice weekly

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

Analysis denominator · Participants

GroupSource count
All Participants27

Reported measurements

Source class 1
Values in E6201 MTD (mg/m^2) IV twice weekly · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants320Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        320
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Phase 1 (Safety Run-In) was conducted in 5 dose cohorts in up to 30 subjects in a standard 3+3 dose-escalation design to establish an MTD and recommended Phase 2 dose (RP2D). Safety assessed through the monitoring of adverse events (AEs), serious adverse events (SAEs), clinical laboratory parameters (hematology and serum chemistry), vital sign measurements, electrocardiograms (ECGs) and physical examinations.
groups
  1. description
    All study participants who received at least 1 dose of E6201 at 240 or 320 mg/m\^2 IV weekly, or at 160, 240 or 320 mg/m\^2 IV twice weekly
    id
    OG000
    title
    All Participants
param Type
NUMBER
population Description
Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication
reporting Status
POSTED
time Frame
Up to 6 weeks for each dose cohort
title
Maximum Tolerated Dose (MTD) of E6201
type
PRIMARY
unit Of Measure
E6201 MTD (mg/m^2) IV twice weekly

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice