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NCT04145349 · OUTCOME

Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)

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
End of ramucirumab infusion on Day 1 of Cycle 1

What was measured

Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose 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.

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 + Vinorelbine14

Reported measurements

Source class 1
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ramucirumab + Cyclophosphamide + Vinorelbine23835Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        35
        value
        238
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose 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.
reporting Status
POSTED
time Frame
End of ramucirumab infusion on Day 1 of Cycle 1
title
Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)
type
SECONDARY
unit Of Measure
microgram per milliliter (µg/mL)

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

Preserved source evidence · Not medical advice