General Drug Use-Results Survey of Tibsovo(biliary tract cancer)

General Drug Use-Results Survey of TIBSOVO Tablets 250 mg (IDH1 mutated nonresectable biliary tract cancer progressed after cancer chemotherapy) (GENTIANA)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031260232

Enrollment

144

Registered

2026-06-19

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IDH1 mutated biliary tract cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with IDH1 mutated nonresectable biliary tract cancer progressed after cancer chemotherapy who receive the first dose of TIBSOVO during this survey period and who agree to participate in the survey

Exclusion criteria

Exclusion criteria: Has a history of hypersensitivity to any of the ingredients of TIBSOVO

Design outcomes

Primary

Measure	Time frame
-Incidence of Guillain-Barre syndrome as AE and ADR	—

Secondary

Measure	Time frame
-Incidence of the other AEs and ADRs -Descriptive statistics of seriousness, severity and timing of onset for AEs and ADRs including Guillain-Barre syndrome -Estimation of factors that are likely to affect safety based on patient characteristics and others -Incidence of AEs and ADRs in patients with specific backgrounds -Tumor response assessment (CR/PR/SD/PD/NE) -Overall response rate (ORR) and disease control rate (DCR) -Analysis of each patient background factor and other factors that are likely to affect efficacy -Overall survival (OS)	—

Measure

Time frame

-Incidence of the other AEs and ADRs -Descriptive statistics of seriousness, severity and timing of onset for AEs and ADRs including Guillain-Barre syndrome -Estimation of factors that are likely to affect safety based on patient characteristics and others -Incidence of AEs and ADRs in patients with specific backgrounds -Tumor response assessment (CR/PR/SD/PD/NE) -Overall response rate (ORR) and disease control rate (DCR) -Analysis of each patient background factor and other factors that are likely to affect efficacy -Overall survival (OS)

—

Contacts

Public ContactPMS NIHON SERVIER CO., LTD.

NIHON SERVIER CO., LTD.

PMS-Japan@ServierGroup.onmicrosoft.com+81-3-4520-2345

Outcome results