A Phase I Study of TS-1 in Combination with ABI-007 every three weeks in Patients with Unresectable or Recurrent Gastric Cancer

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221526

Enrollment

Registered

2011-07-29

Start date

2011-07-29

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

Unresectable or Recurrent gastric cancer

Interventions

investigational material(s) Generic name etc : ABI-007 INN of investigational material : paclitaxel Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Adminis

Cycle 1: from Day 1 morning through Day 14 evening, or from Day 1 evening through Day 15 morning. TS-1 administrated orally for 14 days followed by 7 days rest.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed, written informed consent. - Patient has a histologically or cytologically confirmed gastric adenocarcinoma. Or patient has a clinically confirmed unresectable or recurrent gastric cancer. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

Exclusion criteria: - Patient who is contraindicated to TS-1 or Paclitaxel.(Refer to Package Insert). - Patient has multiple cancer. - Patient has a clinically significant medical history or disease complication.

Design outcomes

Primary

Measure	Time frame
Safety CTCAE (ver.4.0)	—

Secondary

Measure	Time frame
Pharmacokinetics, Efficacy RECIST (ver.1.1)	—

Outcome results

None listed

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