Randomized phase II study of Valproic acid + weekly paclitaxel in unresectable advanced/recurrent gastric cancer

Randomized phase II study of Valproic acid + weekly paclitaxel in unresectable advanced/recurrent gastric cancer - Phase II study of valproic acid + weekly paclitaxel in gastric cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005887

Enrollment

Registered

2011-08-01

Start date

2011-08-01

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 unresectable advanced/recurrent gastric cancer

Interventions

Valproic acid 15mg/kg/day p.o. weekly paclitaxel 80mg/m2/D1, 8, 15/ q4w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed as gastric cancer 2) PS 0-2 3) Prior therapy < 3 4) 4 weeks later from the end of prior chemo (radio)therapy 5) Sufficient function of important organs 6) Life expectancy > 2 months 7) Patients who can take medication orally 8) Wirtten informed consent

Exclusion criteria

Exclusion criteria: 1) Pregnant women or women who like to be pregnant 2) History of allergy against Cremophol EL 3) Intestinal pneumonia, lung fibrosis, and severe COPD 4) Clinically important infection or acute inflammation 5) Psychological disease 6) Other severe complication or malignancy 7) CNS metastasis 8) Doctor's dicision not to be registered to this study

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
progression free survival response rate	—

Countries

Japan

Contacts

Public ContactSachio Fushida

Kanazawa University Hospital Gastroenterological Surgery

fushida@staff.kanazawa-u.ac.jp076-265-2362

Outcome results

None listed

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