A Phase I Study in Resminostat monotherapy and S-1/Resminostat therapy in Patients with biliary tract or pancreatic cancer

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222812

Enrollment

Registered

2015-04-06

Start date

2015-04-06

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

biliary tract camcer or pancreatic cancer

Interventions

investigational material(s) Generic name etc : YHI-1001+S-1 INN of investigational material : YHI-1001:Resminostat, S-1:tegafur, gimeracil, oteracil potassium Therapeutic category code : 429 Other ant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with unresectable/recurrence biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic bile duct carcinoma, gallbladder carcinoma and ampulla of Vater carcinoma) or unresectable/recurrence pancreatic cancer (2)Patients who have received more than one regimen systemic chemotherapy history for biliary tract cancer or pancreatic cancer (3)Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 (4)Patients who are able to ingest resminostat orally and have no gastrointestinal disturbance that, in the judgment of the investigator, may affect the absorption of resminostat

Exclusion criteria

Exclusion criteria: (1)Patients who have taken HDAC inhibitor (2)Pregnant women or lactating mothers (3)Patients with brain metastases or suspected brain metastases based on the clinical symptoms

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Efficacy, Pharmacokinetics	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026