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

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299880
• Other study ID #: BBI608-901
• Secondary ID: 2019-004753-87
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: November 2023
• Source: Sumitomo Pharma America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 30, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Drug:
• Napabucasin
Oral
• Nab-paclitaxel
Intravenous
• Gemcitabine
Intravenous
• Nivolumab
Intravenous
• Paclitaxel
Intravenous
• Irinotecan
Intravenous
• Leucovorin
Intravenous
• 5Fluorouracil
Intravenous
• Bevacizumab
Intravenous

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice
Japan	Kyorin University Hospital	Tokyo
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa
Taiwan	Taipei Veterans General Hospital	Taipei City
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Maine Center for Cancer Medicine	Scarborough	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma America, Inc.

Countries where clinical trial is conducted

United States,  France,  Japan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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.	From first dose until 30 days following last dose of napabucasin