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NCT01282463 · OUTCOME

PK: Cmax Icrucumab

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

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

Measure
GEOMETRIC_MEAN
Unit
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI

Analysis population: All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.

Groups in this outcome

Docetaxel + Icrucumab

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on Day 1 and Day 8 of each 21-day 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
Docetaxel + Icrucumab10

Reported measurements

Cycle 1 Cmax

Analysis denominator · Participants

GroupSource count
Docetaxel + Icrucumab8
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Icrucumab47445Not reportedNot reportedNot reported
Cycle 3 Cmax

Analysis denominator · Participants

GroupSource count
Docetaxel + Icrucumab4
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Icrucumab59927Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        45
        value
        474
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 1 Cmax
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        27
        value
        599
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 3 Cmax
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on Day 1 and Day 8 of each 21-day cycle
    id
    OG000
    title
    Docetaxel + Icrucumab
param Type
GEOMETRIC_MEAN
population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.
reporting Status
POSTED
time Frame
Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
title
PK: Cmax Icrucumab
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice