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

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Oncology

Treatments: Drug: Nivolumab; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Leucovorin; Drug: Napabucasin; Drug: 5Fluorouracil; Drug: Irinotecan; Drug: Nab-paclitaxel; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04299880

2019-004753-87 (EudraCT Number)

BBI608-901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 5 patient groups

Napabucasin monotherapy

Other group

Description:

Patients in this arm will receive napabucasin administered orally, twice daily

Treatment:

Drug: Napabucasin

Napabucasin in combination with Gemcitabine and Nab-paclitaxel

Other group

Description:

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.

Treatment:

Drug: Nab-paclitaxel

Drug: Napabucasin

Drug: Gemcitabine

Napabucasin in combination with Nivolumab

Other group

Description:

Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes.

Treatment:

Drug: Napabucasin

Drug: Nivolumab

Napabucasin in combination with paclitaxel

Other group

Description:

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.

Treatment:

Drug: Napabucasin

Drug: Paclitaxel

Napabucasin in combination with FOLFIRI

Other group

Description:

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.

Treatment:

Drug: Leucovorin

Drug: Irinotecan

Drug: Bevacizumab

Drug: Napabucasin

Drug: 5Fluorouracil