Status:
COMPLETED
Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Oncology
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- 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.
- Must be ≥18 years of age.
- 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.
- 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.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at screening.
- 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).
- 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.
- 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
- Permanent discontinuation of napabucasin in the parent study.
- Napabucasin dose interruption for \>4 weeks between the last dose on the parent study and first dose on the rollover study.
- 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.
- Hypersensitivity to napabucasin or one of the excipients.
- Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
- Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
Exclusion
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04299880
Start Date
February 24 2020
End Date
May 30 2021
Last Update
November 8 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
2
Maine Center for Cancer Medicine
Scarborough, Maine, United States, 04074
3
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
4
Centre Antoine Lacassagne
Nice, France, 06100