This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.
This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure. Individual patients will continue to be treated with napabucasin (monotherapy or combination) in accordance with the parent study under which they were enrolled. If the dose was reduced in the parent protocol, the dose of the last visit of the parent study will be used. Patients will be monitored to determine long term safety and tolerability of napabucasin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
7
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Maine Center for Cancer Medicine
Scarborough, Maine, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Centre Antoine Lacassagne
Nice, France
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events, including clinically significant laboratory abnormalities, as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.0), seriousness, and relationship to study therapy.
Time frame: From first dose until 30 days following last dose of napabucasin
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Intravenous
Intravenous
Intravenous
Intravenous
Intravenous
Intravenous
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kyorin University Hospital
Tokyo, Japan
Taipei Veterans General Hospital
Taipei, Taiwan