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A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

NCT02753127 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1253

Last updated 2023-11-15

Study results available
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Summary

This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

Conditions

Interventions

DRUG

Napabucasin

Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).

DRUG

Fluorouracil

DRUG

Leucovorin

DRUG

Irinotecan

DRUG

Bevacizumab

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-04-28
Completion
2021-05-12

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Singapore
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753127 on ClinicalTrials.gov