West Cancer Center

COLON/RECTAL: Metastatic: 2nd Line: “CanStem303C”

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

Title

Boston Biomedical BBI608-303CRC (CANSTEM 303)

Study Title

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

Site Link

NCT02753127

Malignancy

Colon, metastatic CRC, rectal cancer, colorectal, rectum

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line

Investigational Agent

BBI-608 (napabucasin)

Drug Class

STAT3 inhibitor

Brad Somer, MD

Sponsor

Boston Biomedical, Inc.

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

NCT02753127

Key Eligibility Criteria Details

Metastatic histologically confirmed CRC
Must have failed treatment with one regimen containing a fluoropyrimidine and oxaliplatin for metastatic disease. All patients must have received a minimum of 6 weeks of the first line therapy. Treatment failure is defined as radiologic progression during or <6 months after the last dose of first-line therapy (including adjuvant)
ECOG PS 0-1
Must give access to either archived or new biopsy
No more than 1 prior chemo regimen in metastatic setting
No other cancers within 3 years

Objective

Primary- OS; Secondary; OS in biomarker positive patients, PFS, ORR, DCR, safety, QoL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

colorectal

Dosing Frequency

BBI-608 240mg PO bid

Control Agents

FOLFIRI +/- bevacizumab

Study Protocol

Randomized

Yes