GS-US-401-1787,Open label Study - Long-term Safety of ONO/GS-4059
Research type
Research Study
Full title
An Open-label Study to Assess the Long-term Safety and Efficacy of ONO/GS-4059 in Subjects with Relapsed/Refractory B-cell malignancies.
IRAS ID
184150
Contact name
Martin Dyer
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2015-001404-58
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
The purpose of this study is to determine the long-term safety and tolerability of ONO/GS-4059 in subjects in a prior ONO/GS-4059 study and whose disease had not progressed on the parent study.
ONO/GS-4059, is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) in the treatment of B-cell malignancies. It was initially evaluated in a Phase 1 single agent dose escalation study, ONO-4059POE001, conducted in the United Kingdom (UK). As of January 2015, this study has enrolled and treated approximately 90 subjects with relapsed CLL, non-GCB DLBCL, MCL, SLL, and other indolent non-Hodgkin’s lymphomas (iNHLs). Tolerability and efficacy were demonstrated in subjects with CLL at doses ranging from 40 to 600 mg once daily with no maximum tolerated dose (MTD) identified. Responses were observed in subjects in the NHL cohort at doses from 40 to 480 mg. Dose limiting toxicities (DLTs) of rash, and non-immune reaction were observed at 600 mg once daily in the NHL cohort.
Many patients that are currently on treatment with GS-4059 have had no significant adverse events were seen in patients currently on GS-4059 and the efficacy of this drug was shown to be good.
The study will take place at about 3 centres in the United Kingdom. There will be approximately 32 patients. The study will last approximately 2 years.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0263
Date of REC Opinion
15 Sep 2015
REC opinion
Further Information Favourable Opinion