Clinical trial NCT04299880: Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols
Official title: A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oncology
Keywords: Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Pancreatic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Digestive System Diseases
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual patients will continue to be treated with napabucasin (monotherapy or combination) in accordance with the parent study under which they were enrolled.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From first dose until 30 days following last dose of napabucasin
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: