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Clinical trial · no report yet · Phase 3
PROOF 301
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
- NCT03773302 ↗
- Terminated
- QED Therapeutics, a BridgeBio company
- Focused
We haven't built an HCP commentary report on PROOF 301 (infigratinib in first-line advanced cholangiocarcinoma with FGFR2 gene fusions/translocations) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on PROOF 301 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 7 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 3
- Status
- Terminated
- Conditions
- Advanced Cholangiocarcinoma; FGFR2 Gene Mutation
- Interventions
- BGJ398; Gemcitabine; Cisplatin
- Arms
- Infigratinib (BGJ398) 125 mg · Experimental
- Gemcitabine + Cisplatin · Active comparator
- Enrollment
- 48
- Primary outcomes
- Progression-free Survival (Central Imaging Assessment)
- Sponsor
- QED Therapeutics, a BridgeBio company with Helsinn Healthcare SA
- Start
- Dec 27, 2019
- Primary completion
- Mar 2, 2023
- Results posted
- Yes
- Registry record
- NCT03773302 · updated May 8, 2024
Publications
linked from the registry- Makawita S, K Abou-Alfa G, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, Cohn A, Lamarca A, Oh DY, Macarulla T, T Shroff R, Howland M, Li A, Cho T, Pande A, Javle M. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020 Oct;16(30):2375-2384. doi: 10.2217/fon-2020-0299. Epub 2020 Jun 25. PubMed 32580579