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NCT02365597 · OUTCOME

Main Study: Plasma Concentration of Erdafitinib at 4 Hours (C4h)

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 4 hours post-dose (each cycle length=28 days)

What was measured

C4h is the plasma concentration of erdafitinib at 4 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 mg91

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 mg91
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg504.0189.6Not reportedNot reportedNot reported
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg290.0117.9Not reportedNot reportedNot reported
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg365.3155.6Not reportedNot reportedNot reported
Cycle 1 Day 21

Analysis denominator · Participants

GroupSource count
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg24
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg60
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg46
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg1753.4917.8Not reportedNot reportedNot reported
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg1257.4663.2Not reportedNot reportedNot reported
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg1329.9550.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        189.6
        value
        504.0
      2. group Id
        OG001
        spread
        117.9
        value
        290.0
      3. group Id
        OG002
        spread
        155.6
        value
        365.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        74
      3. group Id
        OG002
        value
        91
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        917.8
        value
        1753.4
      2. group Id
        OG001
        spread
        663.2
        value
        1257.4
      3. group Id
        OG002
        spread
        550.1
        value
        1329.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        60
      3. group Id
        OG002
        value
        46
      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
      91
    units
    Participants
description
C4h is the plasma concentration of erdafitinib at 4 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 4 hours post-dose (each cycle length=28 days)
title
Main Study: Plasma Concentration of Erdafitinib at 4 Hours (C4h)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice