CBGJ398X2204
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 2N = 122NCT02150967
- Population
- Adults with locally advanced or metastatic cholangiocarcinoma and FGFR2 fusions or rearrangements who had received at least one gemcitabine-containing regimen.
- Design
- Multicentre, open-label, single-arm phase 2 study at 18 academic centres and hospitals of infigratinib 125 mg orally once daily for 21 days of 28-day cycles until progression, intolerance, withdrawal of consent or death. Primary endpoint: objective response by blinded independent central review (RECIST 1.1) in the full analysis set. 122 patients were enrolled; the 108 with FGFR2 fusions or rearrangements who received at least one dose formed the full analysis set. The registry record (NCT02150967, terminated) lists a larger actual enrolment of 143. Single-arm; no comparison group.
- Primary endpoint
- ORR
- Arms
- Infigratinib (experimental, n = 108): Infigratinib 125 mg orally once daily for 21 days of 28-day cycles
- People
- Javle M
Show the numbers
| Endpoint | Analysis | Infigratinib | Control | Effect |
|---|---|---|---|---|
| ORRFull analysis set: FGFR2 fusions or rearrangements, at least one dose (108)Best overall response of confirmed complete or partial response, by blinded independent central review | primarymedian follow-up 10.6 monthsJavle 2021 | 23.1% (15.6–32.2%) | — | 25 of 108 patients responded (one complete and 24 partial responses). |
| Endpoint | Analysis | Infigratinib | Control | Effect |
|---|---|---|---|---|
| ORRFull analysis set: FGFR2 fusions or rearrangements, at least one dose (108)Best overall response of confirmed complete or partial response, by blinded independent central review | primarymedian follow-up 10.6 monthsJavle 2021 | 23.1% (15.6–32.2%) | — | 25 of 108 patients responded (one complete and 24 partial responses). |
Appears in
Sources
Javle M, Roychowdhury S, Kelley RK, Sadeghi S, Macarulla T, Weiss KH, et al. 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;6(10):803-815.