ONO-7912 Phase I Study (ONO-7912-01)

ONO-7912 Phase I Study A multicenter, open-label, uncontrolled study in pancreatic cancer (ONO-7912-01)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225264

Enrollment

Registered

2020-07-03

Start date

2020-10-01

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

Patients with pancreatic cancer refractory or intolerance to chemotherapy including gemcitabine

Interventions

investigational material(s) Generic name etc : devimistat (ONO-7912) INN of investigational material : devimistat Therapeutic category code : 429 Other antitumor agents Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with invasive pancreatic ductal carcinoma determined as adenocarcinoma histologically or cytologically 2. Patients who received one regimen of chemotherapy including gemcitabine for pancreatic cancer. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 4. Have a life expectancy of at least 90 days

Exclusion criteria

Exclusion criteria: 1. Patients in whom oxaliplatin, irinotecan, fluorouracil, or levofolinate calcium is contraindicated 2. Patients with clinically relevant diarrhea (including watery stools) 3. Patients with grade >=2 peripheral motor neuropathy or peripheral sensory neuropathy 4. Patients who have received ONO-7912

Design outcomes

Primary

Measure	Time frame
safety Tolerability, safety	—

Secondary

Measure	Time frame
efficacy exploratory pharmacokinetics Overall response rate, disease control rate, overall survival	—

Countries

Japan

Outcome results

None listed

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