Trial Profile
A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 12 Mar 2024
Price :
$35
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At a glance
- Drugs Infigratinib (Primary) ; Cisplatin; Gemcitabine
- Indications Cholangiocarcinoma
- Focus Registrational; Therapeutic Use
- Acronyms PROOF 301; The PROOF Trial
- Sponsors QED Therapeutics
- 20 Jan 2024 Results assessing safety and efficacy of infigratinib vs. gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma presented at the 2024 Gastrointestinal Cancers Symposium
- 29 Mar 2023 Status changed from active, no longer recruiting to discontinued.
- 26 Mar 2023 This trial has been completed in Germany (Date of the global end of the trial: 01-Mar-2023), according to the European Clinical Trials Database record.