NCT00355472 · OUTCOME

Maximum Tolerated Dose (MTD)

Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL · Source last updated 2012-10-18

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

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

What was measured

The dose level at which Dose-Limiting Toxicity (DLT) was recognized was to be regarded as Maximum Tolerated Dose (MTD), and the dose level below MTD by one level was to be regarded as the recommended dose level (when MTD was not reached, 1.0 mg/kg was to be regarded as the recommended dose level) and 3 more subjects were to be newly added to the recommended dose level.

Groups in this outcome

KW-0761

KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL

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
KW-0761	16

Reported measurements

Source class 1

Values in mg/kg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
KW-0761	1.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1.0

denoms

counts
group Id
OG000
value
16
units
Participants

description

groups

description
KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
id
OG000
title
KW-0761

param Type

NUMBER

reporting Status

POSTED

time Frame

28 days

title

Maximum Tolerated Dose (MTD)

type

PRIMARY

unit Of Measure

mg/kg

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

Preserved source evidence · Not medical advice