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NCT04145349 · OUTCOME

PK: Minimum Serum Concentration of Ramucirumab (Cmin)

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor · Source last updated 2026-08-07

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
Prior to ramucirumab infusion on - Day 15 of Cycle 1 and Day 1 of Cycles 2, 4, 7, and 10

What was measured

Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics.

Analysis population: All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data for this outcome. Number analyzed refers to participants evaluable at specified time points.

Groups in this outcome

Ramucirumab + Cyclophosphamide + Vinorelbine

Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

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

Analysis denominator · Participants

GroupSource count
Ramucirumab + Cyclophosphamide + Vinorelbine13

Reported measurements

Day 15 of Cycle 1

Analysis denominator · Participants

GroupSource count
Ramucirumab + Cyclophosphamide + Vinorelbine13
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ramucirumab + Cyclophosphamide + Vinorelbine41.657Not reportedNot reportedNot reported
Day 1 of Cycle 2

Analysis denominator · Participants

GroupSource count
Ramucirumab + Cyclophosphamide + Vinorelbine9
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ramucirumab + Cyclophosphamide + Vinorelbine88.747Not reportedNot reportedNot reported
Day 1 of Cycle 4

Analysis denominator · Participants

GroupSource count
Ramucirumab + Cyclophosphamide + Vinorelbine7
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ramucirumab + Cyclophosphamide + Vinorelbine15737Not reportedNot reportedNot reported
Day 1 of Cycle 7

Analysis denominator · Participants

GroupSource count
Ramucirumab + Cyclophosphamide + Vinorelbine4
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ramucirumab + Cyclophosphamide + Vinorelbine15528Not reportedNot reportedNot reported
Day 1 of Cycle 10

Analysis denominator · Participants

GroupSource count
Ramucirumab + Cyclophosphamide + Vinorelbine2
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ramucirumab + Cyclophosphamide + VinorelbineNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported:151 µg/mL, 207 µg/mL.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        57
        value
        41.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Day 15 of Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        47
        value
        88.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Day 1 of Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        37
        value
        157
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Day 1 of Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        28
        value
        155
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 1 of Cycle 7
  5. categories
    1. measurements
      1. comment
        Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported:151 µg/mL, 207 µg/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Day 1 of Cycle 10
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
    id
    OG000
    title
    Ramucirumab + Cyclophosphamide + Vinorelbine
param Type
GEOMETRIC_MEAN
population Description
All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data for this outcome. Number analyzed refers to participants evaluable at specified time points.
reporting Status
POSTED
time Frame
Prior to ramucirumab infusion on - Day 15 of Cycle 1 and Day 1 of Cycles 2, 4, 7, and 10
title
PK: Minimum Serum Concentration of Ramucirumab (Cmin)
type
SECONDARY
unit Of Measure
microgram per milliliter (µg/mL)

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

Preserved source evidence · Not medical advice