Phase II study of ABI-007 in combination with Ramucirumab

A phase II study of ABI-007 in combination with Ramucirumab in patients with unresectable/recurrent gastric cancer refractory to prior chemotherapy containing fluoropyrimidines

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223034

Enrollment

Registered

2015-12-02

Start date

2015-12-02

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

On Days 1, 8, and 15 of each 28-day cycle, patients will receive 100 mg/m2 of body surface area once daily as a 30-minute intravenous infusion. This will be repeated until any of the criteria is met f

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 Investigator's (sub investigator's) judgment on ineligibility

Design outcomes

Primary

Measure	Time frame
Overall response rate RECIST ver.1.1	—

Secondary

Measure	Time frame
Progression free survival, overall survival, incidence and severity of adverse events and treatment related adverse events RECIST ver.1.1 CTCAE v4.0	—

Outcome results

None listed

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