臨床研究等提出・公開システム

A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Sumitomo Dainippon Pharma Oncology, Inc.-sponsored Napabucasin Protocols

A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in SDP Oncology-sponsored Napabucasin Protocols

No

Sumitomo Dainippon Pharma Co., Ltd

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cc@ds-pharma.co.jp

Sumitomo Dainippon Pharma Co., Ltd

-

-

cc@ds-pharma.co.jp

completed

Feb. 25, 2020

Interventional

Open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin This long-term study is to evaluate the long-term safety of napabucasin in patients who participated in a prior SDP Oncology-sponsored study (parent study) and: -are being treated with napabucasin (monotherapy or combination). -have no evidence of progressive disease, or as long as the patient is deriving clinical benefit according to Investigator's clinical judgement. -have tolerated the study drug in the parent study without significant toxicities.

treatment purpose

3

Patients must fulfill all the following criteria to be eligible for admission to the study:
1) The patient is currently participating in a SDP Oncology-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.
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.

Patients who fulfill any of the following criteria are not eligible for admission to the study:
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.

Both

Pancreatic cancer

investigational material(s)
Generic name etc : BBI-608, BBI608, BB608
INN of investigational material : Napabucasin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Oral administration

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
To evaluate the long-term safety and tolerability of napabucasin through the evaluation of AEs, clinically significant physical examination findings, and clinically relevant laboratory results.

other
No secondary endpoints are defined for this rollover study.

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Feb. 05, 2020

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Feb. 05, 2020