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NCT04145700 · OUTCOME

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

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma · Source last updated 2023-09-13

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
0.5 hours after the 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.

Groups in this outcome

Ramucirumab + Gemcitabine + Docetaxel

Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

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 + Gemcitabine + Docetaxel10

Reported measurements

Source class 1
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ramucirumab + Gemcitabine + Docetaxel23143Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        43
        value
        231
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    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 intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
    id
    OG000
    title
    Ramucirumab + Gemcitabine + Docetaxel
param Type
GEOMETRIC_MEAN
population Description
All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data.
reporting Status
POSTED
time Frame
0.5 hours after the 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