Phase I Study of Oral PQR309 in Patients with Advanced Solid Tumors
Research type
Research Study
Full title
Phase I Study of Oral PQR309 in Patients with Advanced Solid Tumors
IRAS ID
193390
Contact name
Martin Forster
Contact email
Sponsor organisation
PIQUR Therapeutics AG
Eudract number
2015-003919-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
This is an open label study in patients with advanced solid tumours. The study has 2 parts. In Part 1, the objective is to find the optimal dosing schedule for PQR309. In Part 2, the expansion part, the objective is to evaluate the efficacy of PQR309. Patients will be allocated to one of 3 dosing schedules, either continuous daily dosing, or intermittent dosing schedules in which the drug will be taken on 2 consecutive days and no treatment for 5 days OR taken every week on Monday and Thursday. The continuous daily dosing will be at the Maximum Tolerated Dose (MTD). The intermittent doses will be increased by 20mg per cohort depending on safety. Patients will be closely monitored for adverse events. At least 3 patients will be entered at each dose level. If no dose limiting toxicities (DLTs)occur the next dose level will commence. If dose limiting toxicities occur the cohort will be expanded to include 6 patients. Once 2 DLTs, are observed, the MTD for this schedule will have been reached.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0007
Date of REC Opinion
15 Feb 2016
REC opinion
Further Information Favourable Opinion