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NCT02564198 · OUTCOME

Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors · Source last updated 2021-08-17

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

Measure
GEOMETRIC_MEAN
Unit
microgram per milliliter (µg/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI)

What was measured

Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab.

Analysis population: All randomized participants who received at least one dose of study drug and had evaluable PK data. Per protocol, 12 mg/kg Ramucirumab PK data were reported per dose level combining Part A and B participants.

Groups in this outcome

8 mg/kg Ramucirumab

Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.

12 mg/kg Ramucirumab

Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

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

Analysis denominator · Participants

GroupSource count
8 mg/kg Ramucirumab8
12 mg/kg Ramucirumab19

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
8 mg/kg Ramucirumab8
12 mg/kg Ramucirumab19
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
8 mg/kg Ramucirumab30.032Not reportedNot reportedNot reported
12 mg/kg Ramucirumab48.341Not reportedNot reportedNot reported
Cycle 1 Day 43

Analysis denominator · Participants

GroupSource count
8 mg/kg Ramucirumab4
12 mg/kg Ramucirumab16
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
8 mg/kg Ramucirumab53.631Not reportedNot reportedNot reported
12 mg/kg Ramucirumab80.244Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        32
        value
        30.0
      2. group Id
        OG001
        spread
        41
        value
        48.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31
        value
        53.6
      2. group Id
        OG001
        spread
        44
        value
        80.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    Cycle 1 Day 43
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.
    id
    OG000
    title
    8 mg/kg Ramucirumab
  2. description
    Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
    id
    OG001
    title
    12 mg/kg Ramucirumab
param Type
GEOMETRIC_MEAN
population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data. Per protocol, 12 mg/kg Ramucirumab PK data were reported per dose level combining Part A and B participants.
reporting Status
POSTED
time Frame
Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI)
title
Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
type
PRIMARY
unit Of Measure
microgram per milliliter (µg/mL)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice