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Clinical trial · no report yet · Phase 2
NCT02150967
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
- NCT02150967 ↗
- Terminated
- QED Therapeutics, a BridgeBio company
- Focused
We haven't built an HCP commentary report on NCT02150967 (BGJ398 in Advanced Cholangiocarcinoma) 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 NCT02150967 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 | 3 |
The trial
ClinicalTrials.gov- Official title
- A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy
- Phase
- Phase 2
- Status
- Terminated
- Conditions
- Advanced Cholangiocarcinoma; FGFR2 Gene Mutation
- Interventions
- BGJ398 (infigratinib)
- Arms
- BGJ398 (infigratinib) · Experimental
- Enrollment
- 143
- Primary outcomes
- Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR)
- Sponsor
- QED Therapeutics, a BridgeBio company with Helsinn Healthcare SA
- Start
- Jul 23, 2014
- Primary completion
- Mar 1, 2021
- Results posted
- Yes
- Registry record
- NCT02150967 · updated Jul 3, 2023
Publications
linked from the registry- Javle M, Roychowdhury S, Kelley RK, Sadeghi S, Macarulla T, Weiss KH, Waldschmidt DT, Goyal L, Borbath I, El-Khoueiry A, Borad MJ, Yong WP, Philip PA, Bitzer M, Tanasanvimon S, Li A, Pande A, Soifer HS, Shepherd SP, Moran S, Zhu AX, Bekaii-Saab TS, Abou-Alfa GK. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):803-815. doi: 10.1016/S2468-1253(21)00196-5. Epub 2021 Aug 3. PubMed 34358484
- Javle M, Lowery M, Shroff RT, Weiss KH, Springfeld C, Borad MJ, Ramanathan RK, Goyal L, Sadeghi S, Macarulla T, El-Khoueiry A, Kelley RK, Borbath I, Choo SP, Oh DY, Philip PA, Chen LT, Reungwetwattana T, Van Cutsem E, Yeh KH, Ciombor K, Finn RS, Patel A, Sen S, Porter D, Isaacs R, Zhu AX, Abou-Alfa GK, Bekaii-Saab T. Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma. J Clin Oncol. 2018 Jan 20;36(3):276-282. doi: 10.1200/JCO.2017.75.5009. Epub 2017 Nov 28. PubMed 29182496
- Borad MJ, Gores GJ, Roberts LR. Fibroblast growth factor receptor 2 fusions as a target for treating cholangiocarcinoma. Curr Opin Gastroenterol. 2015 May;31(3):264-8. doi: 10.1097/MOG.0000000000000171. PubMed 25763789