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NCT01536145 · OUTCOME

Pharmacodynamic-based Dose

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycle 1 (Week 4 or Week 8)

What was measured

The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression

Analysis population: Data from analysis of the PK/pharmacodynamic relationship could not permit a reliable estimate of the pharmacodynamic-based dose.

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

GroupSource count
CP-751,871 0.025-20 mg/kg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression
groups
  1. 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
population Description
Data from analysis of the PK/pharmacodynamic relationship could not permit a reliable estimate of the pharmacodynamic-based dose.
reporting Status
POSTED
time Frame
Cycle 1 (Week 4 or Week 8)
title
Pharmacodynamic-based Dose
type
SECONDARY

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

Preserved source evidence · Not medical advice