A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols
Overview
- Phase
- Phase 1
- Intervention
- Napabucasin
- Conditions
- Oncology
- Sponsor
- Sumitomo Pharma America, Inc.
- Enrollment
- 7
- Locations
- 7
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Napabucasin monotherapy
Patients in this arm will receive napabucasin administered orally, twice daily
Intervention: Napabucasin
Napabucasin in combination with Gemcitabine and 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.
Intervention: Napabucasin
Napabucasin in combination with Gemcitabine and 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.
Intervention: Nab-paclitaxel
Napabucasin in combination with Gemcitabine and 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.
Intervention: Gemcitabine
Napabucasin in combination with Nivolumab
Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes.
Intervention: Napabucasin
Napabucasin in combination with Nivolumab
Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes.
Intervention: Nivolumab
Napabucasin in combination with 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.
Intervention: Napabucasin
Napabucasin in combination with 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.
Intervention: Paclitaxel
Napabucasin in combination with FOLFIRI
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.
Intervention: Napabucasin
Napabucasin in combination with FOLFIRI
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.
Intervention: Irinotecan
Napabucasin in combination with FOLFIRI
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.
Intervention: Leucovorin
Napabucasin in combination with FOLFIRI
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.
Intervention: 5Fluorouracil
Napabucasin in combination with FOLFIRI
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.
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 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.