NCT01536145 · OUTCOME

Maximum Tolerated Dose (MTD)

CP-751,871 Treatment For Patients With Multiple Myeloma · Source last updated 2013-03-15

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: Baseline up to Cycle 1 (Week 4 or Week 8)

What was measured

The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants

Analysis population: All participants who received at least 1 dose of study drug CP-751,871.

Groups in this outcome

CP-751,871 0.025-20 mg/kg

CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

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
CP-751,871 0.025-20 mg/kg	47

Reported measurements

Source class 1

Values in mg/kg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CP-751,871 0.025-20 mg/kg	NA	Not reported	Not reported	Not reported	CP-751,871 was safe and well tolerated at dose levels up to 20 mg/kg, and MTD was not achieved.

Complete source fields

classes

categories
measurements
comment
CP-751,871 was safe and well tolerated at dose levels up to 20 mg/kg, and MTD was not achieved.
group Id
OG000
value
NA

denoms

counts
group Id
OG000
value
47
units
Participants

description

The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants

groups

description
CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
id
OG000
title
CP-751,871 0.025-20 mg/kg

param Type

NUMBER

population Description

All participants who received at least 1 dose of study drug CP-751,871.

reporting Status

POSTED

time Frame

Baseline up to Cycle 1 (Week 4 or Week 8)

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