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NCT02365597 · OUTCOME

Main Study: Plasma Concentration of Erdafitinib at 2 Hours (C2h)

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer · Source last updated 2026-08-28

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Days 1 and 21: Pre-dose up to 2 hours post-dose (each cycle length=28 days)

What was measured

C2h is the plasma concentration of erdafitinib at 2 hours.

Analysis population: Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.

Groups in this outcome

Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg

Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg

Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg

Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.

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

Analysis denominator · Participants

GroupSource count
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg32
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg74
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg92

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg32
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg74
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg92
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg529.5224.9Not reportedNot reportedNot reported
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg311.0134.8Not reportedNot reportedNot reported
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg373.0168.1Not reportedNot reportedNot reported
Cycle 1 Day 21

Analysis denominator · Participants

GroupSource count
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg23
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg59
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg45
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg1686.5872.3Not reportedNot reportedNot reported
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg1255.1640.0Not reportedNot reportedNot reported
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg1371.4586.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        224.9
        value
        529.5
      2. group Id
        OG001
        spread
        134.8
        value
        311.0
      3. group Id
        OG002
        spread
        168.1
        value
        373.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        74
      3. group Id
        OG002
        value
        92
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        872.3
        value
        1686.5
      2. group Id
        OG001
        spread
        640.0
        value
        1255.1
      3. group Id
        OG002
        spread
        586.6
        value
        1371.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        59
      3. group Id
        OG002
        value
        45
      units
      Participants
    title
    Cycle 1 Day 21
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      74
    3. group Id
      OG002
      value
      92
    units
    Participants
description
C2h is the plasma concentration of erdafitinib at 2 hours.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    OG000
    title
    Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
  2. description
    Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    OG001
    title
    Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
  3. description
    Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
    id
    OG002
    title
    Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
param Type
MEAN
population Description
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
reporting Status
POSTED
time Frame
Cycle 1 Days 1 and 21: Pre-dose up to 2 hours post-dose (each cycle length=28 days)
title
Main Study: Plasma Concentration of Erdafitinib at 2 Hours (C2h)
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice