A Phase III, Randomized, Open-Label Clinical Study of Napabucasin in Combination with FOLFIRI and Best Supportive Care (BSC) Versus Napabucasin plus BSC in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518204-50-00

Acronym

STEMNESS-CRC

Enrollment

123

Registered

2024-11-11

Start date

2022-04-25

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic.

Brief summary

Overall Survival in the general study population, defined as the time from randomization to death from any cause.

Detailed description

Progression free survival (PFS) in the general study population, Objective response rate (ORR) in the general study population, Disease control rate (DCR) in the general study population, OS, PFS, ORR and DCR in the predefined biomarker positive population, Safety, Quality of Life

Interventions

DRUGBENDAFOLIN 10 mg/ml Injektionslösung

DRUGIrinotecan Bendalis 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUG5-FLUOROURACIL–EBEWE

DRUG50 MG/ML

DRUGROZTWÓR DO WSTRZYKIWAN I INFUZJI

DRUGNapabucasin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival in the general study population, defined as the time from randomization to death from any cause.	—

Secondary

Measure	Time frame
Progression free survival (PFS) in the general study population, Objective response rate (ORR) in the general study population, Disease control rate (DCR) in the general study population, OS, PFS, ORR and DCR in the predefined biomarker positive population, Safety, Quality of Life	—

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026