A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with FGFR Genomic Alterations

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510273-34-00

Acronym

42756493BLC2001

Enrollment

Registered

2024-02-12

Start date

2015-04-24

Completion date

Unknown

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial cancer

Brief summary

Percentage of Participants with Best Overall Response, The endpoints are PK parameters for midazolam and its metabolite (1-OH-midazolam), and for metformin (in the absence or presence of erdafitinib) including but not limited to Cmax, tmax, AUClast, and AUC∞.

Interventions

DRUGMidazolam-ratiopharm® 2 mg/ml orale Lösung

DRUGJNJ-42756493

DRUGMetformin HEXAL 1000 mg Filmtabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Best Overall Response, The endpoints are PK parameters for midazolam and its metabolite (1-OH-midazolam), and for metformin (in the absence or presence of erdafitinib) including but not limited to Cmax, tmax, AUClast, and AUC∞.	—

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026