A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer (BRIGHTER)

A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222639

Enrollment

700

Registered

2014-10-24

Start date

2014-11-14

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

Gastric Cancer, Gastroesophageal Junction Cancer

Interventions

investigational material(s) Generic name etc : BBI608 INN of investigational material : Napabucasin Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Cytologically or histologically confirmed advanced gastric or GEJ adenocarcinoma that is metastatic or locally advanced and unresectable. - Failed treatment with one regimen containing at least a platinum/fluoropyrimidine doublet for unresectable or metastatic disease. - ECOG performance status of 0 or 1 etc.

Exclusion criteria

Exclusion criteria: - Prior taxanes in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxanes in the metastatic setting. - Major surgery within 4 weeks prior to randomization. - Any known symptomatic brain metastases requiring steroids. etc.

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory OS	—

Secondary

Measure	Time frame
safety efficacy confirmatory PFS, DCR, AE, QOL	—

Countries

Asia except Japan, Europe, Japan, Middle East, North America, Oceania, South America

Outcome results

None listed

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