BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Patients With Pretreated Advanced Colorectal Carcinoma

A Phase III Randomized Study of BBI608 and Best Supportive Care Versus Placebo and Best Supportive Care in Patients With Pretreated Advanced Colorectal Carcinoma

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222249

Enrollment

650

Registered

2013-10-07

Start date

2013-10-07

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

Colorectal Carcinoma

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: - Histologically confirmed advanced colorectal cancer that is unresectable. - The only remaining standard available therapy as recommended by the Investigator is best supportive care. - Must have presence of measurable disease as defined by RECIST 1.1. - Must have an ECOG Performance Status of 0 or 1. etc.

Exclusion criteria

Exclusion criteria: - Major surgery within 4 weeks prior to randomization. - Any known symptomatic brain metastases requiring steroids. etc.

Design outcomes

Primary

Measure	Time frame
- Efficacy OS	—

Secondary

Measure	Time frame
- Efficacy - Safety PFS, DCR, AE, QOL	—

Outcome results

None listed

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