Phase III Clinical Study of ABI-007

Randomized, phase III, comparative study of every-3-weeks dosing, weekly dosing of ABI-007, and weekly dosing of the conventional paclitaxel for patients with unresectable/recurrent gastric cancer refractory to prior chemotherapy containing fluoropyrimidines.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222013

Enrollment

730

Registered

2013-01-28

Start date

2013-01-28

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/recurrent gastric cancer patients refractory to prior chemotherapy containing fluoropyrimidine

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed, written informed consent. - Histologically or cytologically confirmed gastric adenocarcinoma. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion criteria

Exclusion criteria: - Past history of severe drug hypersensitivity - Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE). - Principal Investigators'(sub investigators') judgment on ineligibility

Design outcomes

Primary

Measure	Time frame
Overall Survival:OS Continuous survival confirmation	—

Secondary

Measure	Time frame
Incidence and severity of adverse events and adverse drug reactions Anti-tumor efficacy and progression-free survival (PFS) RECIST (ver.1.1)	—

Outcome results

None listed

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