NCT04299880

Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols

A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Oncology

Interventions

Type	Name	Description
DRUG	Napabucasin	Oral
DRUG	Nab-paclitaxel	Intravenous
DRUG	Gemcitabine	Intravenous
DRUG	Nivolumab	Intravenous
DRUG	Paclitaxel	Intravenous
DRUG	Irinotecan	Intravenous
DRUG	Leucovorin	Intravenous
DRUG	5Fluorouracil	Intravenous
DRUG	Bevacizumab	Intravenous

Timeline

• Start date: 2020-02-24
• Primary completion: 2021-05-15
• Completion: 2021-05-30
• First posted: 2020-03-09
• Last updated: 2023-11-08

Locations

7 sites across 4 countries: United States, France, Japan, Taiwan

Regulatory

• FDA-regulated drug study