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

• Status: Active, not recruiting
• Trial end date: 2022-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Biomedical, Inc; Sumitomo Dainippon Pharma Oncology, Inc
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Nivolumab; Paclitaxel

Criteria

Inclusion Criteria

1. The patient is currently participating in a BBI-sponsored parent study of napabucasin and must be receiving napabucasin as monotherapy or as part of a combination treatment.

2. Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonisation (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.

3. Must be ≥18 years of age.

4. Currently has no evidence of progressive disease, as determined by the investigator, during treatment with napabucasin (either as monotherapy or as part of a combination treatment regimen) or are deriving clinical benefit despite disease progression according to Investigator's clinical judgement.

5. Continued ability to swallow and retain orally administered study drug(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome.

6. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at screening.

7. Non-fertile or agree to use an adequate method of contraception while on study and for 6 months following the last dose and not currently nursing; males agree to use an adequate method of contraception while on study and for 3 months following the last dose (Appendix 3).

8. Patients must be accessible for treatment and follow-up. Patients registered on this trial must receive protocol treatment and be followed at their current (parent study) participating center.

9. Patient agrees not to participate in other interventional clinical studies during their participation in this trial. Patients participating in surveys or observational studies are eligible to participate in this study.

Exclusion Criteria

1. Permanent discontinuation of napabucasin in the parent study.

2. Napabucasin dose interruption for >4 weeks between the last dose on the parent study and first dose on the rollover study.

3. Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin. Women undergoing combination backbone therapy should not breast feed while on combination backbone therapy and for the period of time following discontinuation of combination backbone therapy as specified in the parent protocol.

4. Hypersensitivity to napabucasin or one of the excipients.

5. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.

6. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.