A study of BET Inhibitor BMS-986158 in advanced solid tumours
Research type
Research Study
Full title
A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects with Selected Advanced Solid Tumors
IRAS ID
209782
Contact name
Natalie Cook
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2015-000324-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a multicentre phase I/IIa study to assess the safety, tolerability, pharmacokinetics and preliminary anti-cancer activity of BMS-986158 in patients with advanced and/or metastatic ovarian, triple negative breast, small cell lung and other solid tumours. BMS-986158 is an experimental drug currently in development. The study has two parts. Part 1 is a dose escalation assessment in patients with advanced and/or metastatic solid tumours. Part 2 is a cohort expansion for patients with the above mentioned three specific tumour types, who will receive the recommended dose from Part 1. This dose may be either the maximum tolerated dose (MTD), maximum administered dose, or an alternative dose as agreed upon by the Sponsor and Investigators. Patients in the UK will participate in Part 2 only. \nIn Part 2, patients will receive oral BMS-986158 according to one of the 3 continued dosing schedules, A (5 days on, 2 days off study drug), B (14 days on, 7 days off) or C (7 days on, 14 days off), until disease progression, unacceptable adverse events or withdrawal of consent. \nPatients will undergo the following study procedures: CT/MRI scans, ECG tests, physical examinations, vital signs and bloods for routine safety and study specific testing. Patients may also have a tumour biopsy done.\nPatients will have a Clinical follow-up visit 30 days after the last dose of the study treatment, followed by phone or hospital visits every 12 weeks for approximately 2 years from the first dose of study drug. Patients receiving study drug for more than 2 years will participate to the follow-up for 6 months from their last dose.\nThe study will be conducted by trained oncology teams in specialised NHS clinics. The study is sponsored by Bristol-Myers Squibb.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0564
Date of REC Opinion
23 Sep 2016
REC opinion
Further Information Favourable Opinion