NCT02365597 · OUTCOME

Main Study: Percentage of Participants With Best (Overall) Objective Response

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: NUMBER
Unit: Percentage of Participants
Interval / dispersion: Not reported
Time frame: From Cycle 1 Day 1 up to 6 years 2 months

What was measured

Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responders are participants with BOR of CR or PR.

Analysis population: The population included participants who received at least 1 dose of study drug.

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

Group	Source count
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg	33
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg	78
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg	101

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg	21.2	Not reported	Not reported	Not reported	Not reported
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg	34.6	Not reported	Not reported	Not reported	Not reported
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg	39.6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
21.2
group Id
OG001
value
34.6
group Id
OG002
value
39.6

denoms

counts
group Id
OG000
value
33
group Id
OG001
value
78
group Id
OG002
value
101
units
Participants

description

groups

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
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
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

NUMBER

population Description

The population included participants who received at least 1 dose of study drug.

reporting Status

POSTED

time Frame

From Cycle 1 Day 1 up to 6 years 2 months

title

Main Study: Percentage of Participants With Best (Overall) Objective Response

type

PRIMARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice