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NCT02451943 · OUTCOME

Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma · Source last updated 2025-07-15

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

Measure
MEAN
Unit
Liter/hour (L/h)
Interval / dispersion
95% Confidence Interval
Time frame
Cycle 1- 9: Day 1 and 8, Predose, 5 minutes Post dose and then every other cycle and follow-up (30 Days)

What was measured

The PK systemic clearance parameter estimates from the current analysis are listed together with the population PK model estimates.

Analysis population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Groups in this outcome

Doxorubicin + Olaratumab

75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.

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

Analysis denominator · Participants

GroupSource count
Doxorubicin + Olaratumab258

Reported measurements

Source class 1
Values in Liter/hour (L/h) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Doxorubicin + Olaratumab0.0195Not reported0.01890.0203Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0189
        upper Limit
        0.0203
        value
        0.0195
denoms
  1. counts
    1. group Id
      OG000
      value
      258
    units
    Participants
description
The PK systemic clearance parameter estimates from the current analysis are listed together with the population PK model estimates.
dispersion Type
95% Confidence Interval
groups
  1. description
    75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
    id
    OG000
    title
    Doxorubicin + Olaratumab
param Type
MEAN
population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data.
reporting Status
POSTED
time Frame
Cycle 1- 9: Day 1 and 8, Predose, 5 minutes Post dose and then every other cycle and follow-up (30 Days)
title
Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate
type
SECONDARY
unit Of Measure
Liter/hour (L/h)

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

Preserved source evidence · Not medical advice