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

Phase 1

Completed

• Conditions: Oncology
• Interventions: Drug: Napabucasin; Drug: Nivolumab; Drug: Nab-paclitaxel; Drug: Paclitaxel; Drug: Irinotecan; Drug: Leucovorin; Drug: Gemcitabine; Drug: 5Fluorouracil; Drug: Bevacizumab

• Registration Number: NCT04299880
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief 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.

Study Timeline

• Study Start: 2020-02-24
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-09
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Napabucasin in combination with FOLFIRI	5Fluorouracil	Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly FOLFIRI. Addition of bevacizumab, per Investigator choice, will be permissible.
Napabucasin monotherapy	Napabucasin	Patients in this arm will receive napabucasin administered orally, twice daily
Napabucasin in combination with Nivolumab	Nivolumab	Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes.
Napabucasin in combination with Gemcitabine and Nab-paclitaxel	Nab-paclitaxel	Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously once weekly, on 3 of every 4 weeks.
Napabucasin in combination with FOLFIRI	Leucovorin	Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly FOLFIRI. Addition of bevacizumab, per Investigator choice, will be permissible.
Napabucasin in combination with Gemcitabine and Nab-paclitaxel	Napabucasin	Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously once weekly, on 3 of every 4 weeks.
Napabucasin in combination with Gemcitabine and Nab-paclitaxel	Gemcitabine	Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously once weekly, on 3 of every 4 weeks.
Napabucasin in combination with paclitaxel	Paclitaxel	Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly paclitaxel administered intravenously once weekly, on 3 of every 4 weeks.
Napabucasin in combination with FOLFIRI	Irinotecan	Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly FOLFIRI. Addition of bevacizumab, per Investigator choice, will be permissible.
Napabucasin in combination with FOLFIRI	Bevacizumab	Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly FOLFIRI. Addition of bevacizumab, per Investigator choice, will be permissible.
Napabucasin in combination with Nivolumab	Napabucasin	Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes.
Napabucasin in combination with paclitaxel	Napabucasin	Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly paclitaxel administered intravenously once weekly, on 3 of every 4 weeks.
Napabucasin in combination with FOLFIRI	Napabucasin	Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly FOLFIRI. Addition of bevacizumab, per Investigator choice, will be permissible.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	From first dose until 30 days following last dose of napabucasin	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.

Trial Locations

Locations (7)

Kyorin University Hospital; 🇯🇵 Tokyo, Japan

Maine Center for Cancer Medicine; 🇺🇸 Scarborough, Maine, United States

Winship Cancer Institute, Emory University; 🇺🇸 Atlanta, Georgia, United States

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

Kanagawa Cancer Center; 🇯🇵 Yokohama, Kanagawa, Japan

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Taipei Veterans General Hospital; 🇨🇳 Taipei City, Taiwan