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JNJJanssen Research & Development, LLCRunning, no new patients

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

Urothelial Cancer

2Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

  • 4 insiders sold shares within a month

    Since Aug 17, 2026 · was worth 5, fading over time

    +2
Worry score2

Score over time

Stage
Phase 2
Patients
239 (final count)
Started
Apr 22, 2015
Main results expected
Sep 15, 2022
Fully finished
Mar 31, 2027
Results posted
Oct 10, 2023

What counts as success

The trial's main goal(s), called the “primary outcome.”

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

    Measured over: From Cycle 1 Day 1 up to 6 years 2 months

  • Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -2 (predose) up to Day 13 post dose

  • Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Metformin Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Midazolam Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

Changes Tremor has spotted

No changes since Tremor started watching this trial.
Show details (technical version)

Score inputs

  • insider_selling_cluster: base 5, now 2, since 2026-08-17, fades (half-life)

Raw record changes

  • none yet

Trial ID NCT02365597 · record last updated 2026-09-25 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT02365597) ↗

  • Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Metformin Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Midazolam Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  • Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Metformin Alone or in Combination With Erdafitinib

    Measured over: Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)