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

NCT ID: NCT04299880

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2021-05-30

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.

Conditions

Oncology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Napabucasin monotherapy

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

Group Type: OTHER

Napabucasin

Intervention Type: DRUG

Oral

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.

Group Type: OTHER

Napabucasin

Intervention Type: DRUG

Oral

Nab-paclitaxel

Intervention Type: DRUG

Intravenous

Gemcitabine

Intervention Type: DRUG

Intravenous

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.

Group Type: OTHER

Napabucasin

Intervention Type: DRUG

Oral

Nivolumab

Intervention Type: DRUG

Intravenous

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.

Group Type: OTHER

Napabucasin

Intervention Type: DRUG

Oral

Paclitaxel

Intervention Type: DRUG

Intravenous

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.

Group Type: OTHER

Napabucasin

Intervention Type: DRUG

Oral

Irinotecan

Intervention Type: DRUG

Intravenous

Leucovorin

Intervention Type: DRUG

Intravenous

5Fluorouracil

Intervention Type: DRUG

Intravenous

Bevacizumab

Intervention Type: DRUG

Intravenous

Interventions

Napabucasin

Oral

Intervention Type: DRUG

Nab-paclitaxel

Intravenous

Intervention Type: DRUG

Gemcitabine

Intravenous

Intervention Type: DRUG

Nivolumab

Intravenous

Intervention Type: DRUG

Paclitaxel

Intravenous

Intervention Type: DRUG

Irinotecan

Intravenous

Intervention Type: DRUG

Leucovorin

Intravenous

Intervention Type: DRUG

5Fluorouracil

Intravenous

Intervention Type: DRUG

Bevacizumab

Intravenous

Intervention Type: DRUG

Other Intervention Names

BBI608; BBI-608; BB608; Abraxane; Gemzar; Opdivo; Taxol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Maine Center for Cancer Medicine

Scarborough, Maine, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Centre Antoine Lacassagne

Nice, , France

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Kyorin University Hospital

Tokyo, , Japan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

United States; France; Japan; Taiwan

Other Identifiers

2019-004753-87

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BBI608-901

Identifier Type: -

Identifier Source: org_study_id