Terminated PHASE3 INTERVENTIONAL 2-arm NCT04197986

Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF302)

Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)

Sponsor: Helsinn Healthcare SA

Conditions Upper Tract Urothelial Carcinomas Urothelial Bladder Cancer

Interventions Infigratinib Placebo

Updated 23 times since 2020 Last updated: Feb 16, 2024 Started: Mar 11, 2020 Primary completion: Feb 28, 2023 Completion: Feb 28, 2023

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The sponsor has decided to close the study due to the discontinuation of infigratinib development. The discontinuation of the study was not due to safety reasons.

Other terminated trials from Helsinn Healthcare SA

More terminations from Helsinn Healthcare SA

Listed as NCT04197986, this PHASE3 trial focuses on Upper Tract Urothelial Carcinomas and Urothelial Bladder Cancer and remains terminated or withdrawn. Sponsored by Helsinn Healthcare SA, it has been updated 23 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

23 versions recorded

Dec 2025 — Present [monthly]

Terminated PHASE3
Sep 2025 — Dec 2025 [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Apr 2024 — Jul 2024 [monthly]

Terminated PHASE3

▶ Show 18 earlier versions

Mar 2023 — Apr 2024 [monthly]

Terminated PHASE3

Status: Active Not Recruiting → Terminated
Nov 2022 — Mar 2023 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Sep 2022 — Nov 2022 [monthly]

Recruiting PHASE3
May 2022 — Sep 2022 [monthly]

Recruiting PHASE3
Mar 2022 — May 2022 [monthly]

Recruiting PHASE3
Jan 2022 — Mar 2022 [monthly]

Recruiting PHASE3
Oct 2021 — Jan 2022 [monthly]

Recruiting PHASE3
Sep 2021 — Oct 2021 [monthly]

Recruiting PHASE3
May 2021 — Sep 2021 [monthly]

Recruiting PHASE3
Apr 2021 — May 2021 [monthly]

Recruiting PHASE3
Mar 2021 — Apr 2021 [monthly]

Recruiting PHASE3
Feb 2021 — Mar 2021 [monthly]

Recruiting PHASE3
Jan 2021 — Feb 2021 [monthly]

Recruiting PHASE3
Nov 2020 — Jan 2021 [monthly]

Recruiting PHASE3
Aug 2020 — Nov 2020 [monthly]

Recruiting PHASE3
Apr 2020 — Aug 2020 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Feb 2020 — Apr 2020 [monthly]

Not Yet Recruiting PHASE3
Jan 2020 — Feb 2020 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Helsinn Healthcare SA
QED Therapeutics, a BridgeBio company

Data source: QED Therapeutics, a BridgeBio company

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albany, United States , Amsterdam, Netherlands , Antwerp, Belgium , Arlington, United States , Athens, Greece , Atlanta, United States , Aurora, United States , Aviano, Italy , Badalona, Spain , Baltimore, United States and 100 more locations