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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02753127

Public ClinicalTrials.gov record NCT02753127. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT02753127
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
1,253 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2016 (Type not available)
Primary completion
Apr 28, 2020 (Actual)
Completion
May 12, 2021 (Actual)
Last update posted
Nov 15, 2023

2016 – 2021

United States locations

U.S. sites
74
U.S. states
29
U.S. cities
69
Facility City State ZIP Site status
Alabama Oncology Birmingham Alabama 35223 —
Mayo Clinic Arizona Phoenix Arizona 85054 —
Arizona Oncology Associates, PC - HOPE Tucson Arizona 85771 —
Comprehensive Blood and Cancer Center Bakersfield California 93309 —
City of Hope- Comprehensive Care Center Duarte California 91010 —
University of California-San Diego/Moores UCSD Cancer Center La Jolla California 92093 —
Los Angeles Hematology Oncology Medical Group Los Angeles California 90017 —
USC Norris Comprehensive Cancer Center Los Angeles California 90033 —
UCLA Hematology Oncology Santa Monica Santa Monica California 90404 —
St. Joseph Heritage Healthcare Santa Rosa California 95405 —
Rocky Mountain Cancer Centers Denver Colorado 80218 —
St Mary's Hospital & Regional Med Center Grand Junction Colorado 81501 —
Medical Oncology Hematology Consultants, PA Newark Delaware 19713 —
Florida Cancer Specialists & Research Institute Fort Myers Fort Myers Florida 33901 —
Memorial Cancer Institute at Memorial Hospital Hollywood Florida 33021 —
Baptist Health Medical Group Oncology, LLC Miami Florida 33176 —
Sarah Cannon Research Institution St. Petersburg Florida 33705 —
Palm Beach Cancer Institute West Palm Beach Florida 33401 —
Piedmont Cancer Institute, PC Atlanta Georgia 30318 —
Emory University/Winship Cancer Institute Atlanta Georgia 30322 —
Suburban Hematology-Oncology Associates, PC - Lawrenceville Lawrenceville Georgia 30046 —
Illinois Cancer Specialists Arlington Heights Illinois 60005 —
Northshore University Healthsystem Evanston Illinois 60201 —
Healthcare Research Network III, LLC Tinley Park Illinois 60487 —
Northwestern Medicine Cancer Center Warrenville Illinois 60555 —
Parkview Research Center Fort Wayne Indiana 46845 —
Indiana University Health Goshen Center for Cancer Care Goshen Indiana 46526 —
Michiana Hematology Oncology, PC Mishawaka Indiana 46545 —
Cancer Center of Kansas Wichita Kansas 67214 —
Dana Farber Boston Massachusetts 02215 —
Umass Memorial Medical Center Worcester Massachusetts 01655 —
University of Michigan Cancer Center Ann Arbor Michigan — —
Minnesota Oncology Hematology, P.A. Minneapolis Minnesota 55404 —
Mayo Clinic Arizona Rochester Minnesota 55905 —
Research Medical Center Kansas City Missouri 64132 —
Missouri Baptist Medical Center ACCRU Network Site St Louis Missouri 63131 —
Saint Francis Cancer Treatment Center Grand Island Nebraska 68803 —
Missouri Valley Cancer Consortium Omaha Nebraska 68106 —
Cancer Research Network of Nebraska / Oncology Associates PC Omaha Nebraska 68118 —
Tennessee Oncology PLLC Omaha Nebraska 68118 —
Darthmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 —
Carol G. Simon Cancer Center Morristown New Jersey 07962 —
University of New Mexico Albuquerque New Mexico 87131 —
Roswell Park Cancer Center Buffalo New York 14263 —
North Shore Hematology Oncology Associates East Setauket New York 11733 —
Weill Cornell Medical College New York New York 10065 —
Montefiore Medical Center The Bronx New York 10467 —
Southeastern Medical Oncology Center Goldsboro North Carolina 27534 —
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157 —
Toledo Clinic Cancer Centers Toledo Ohio 43623 —
Geisinger Medical Center Danville Pennsylvania 17822 —
VA Pittsburgh Healthcare System Pittsburgh Pennsylvania 15240 —
Medical University of South Carolina Charleston South Carolina 29412 —
Sanford Cancer Center Sioux Falls South Dakota 57104 —
University of Tennessee Medical Center Knoxville Tennessee 37920 —
West Cancer Center Memphis Tennessee 38138 —
The Sarah Cannon Research Institute Nashville Tennessee 37203 —
Texas Oncology-Austin Midtown Austin Texas 75705 —
Texas Oncology - Dallas Center Dallas Texas 75203 —
Texas Oncology - Denton South Denton Texas 76210 —
Texas Oncology - Fort Worth Fort Worth Texas 76104 —
Millenium Oncology Houston Texas 77090 —
Texas Health Physicians Group Plano Texas 75093 —
Texas Oncology-San Antonio San Antonio Texas 78217 —
Texas Oncology - Tyler Tyler Texas 75702 —
Texas Oncology - Wichita Falls Texoma Cancer Center Wichita Falls Texas 76310 —
Northern Utah Associates Ogden Utah 84403 —
US Oncology - Virginia Cancer Specialists, PC Fairfax Virginia 22031 —
Fort Belvoir Community Hospital Fort Belvoir Virginia 22060 —
Virginia Oncology Associates Hampton Virginia 23666 —
Blue Ridge Cancer Care Roanoke Virginia 24014 —
Virginia Mason Seattle Washington 98101 —
Seattle Cancer Care Alliance Seattle Washington 98109-1023 —
Northwest Cancer Specialists, P.C. Vancouver Washington 98684 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 137 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02753127, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 15, 2023 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02753127 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →