Phase I study of oral PQR309 in Patients with Advanced Solid Tumours
Research type
Research Study
Full title
Phase I study of oral PQR309 in Patients with Advanced Solid Tumors
IRAS ID
135857
Contact name
Rebecca Kristeleit
Contact email
Eudract number
2013-003441-42
Clinicaltrials.gov Identifier
Research summary
This is an open label dose-finding Phase I study to determine the maximum tolerated dose (MTD) and preliminary efficacy in patients with advanced solid tumours. The study will be split into 2 parts. In Part A, patients will be allocated in cohorts to increasing dose levels according to safety experienced as the study progresses. In Part B patients will be treated at the MTD or recommended phase II dose (RP2D). Patients will receive the same dose throughout the study until disease progression or unacceptable toxicity occurs.
An independent safety board will review the data prior to approving dose escalation to a higher dose. The dosing will start at a low dose (10mg per day) deemed to be safe according to the preclinical data. Dosing will double until dose level 4 (80mg) unless toxicity is seen. At this level (4) the dose will be increased by 1.5 (120mg).
The design of the study is a modified 3+3 design. The first 2 dose levels, which are considered to be sub-therapeutic, will enter 1 patient per dose level. At dose level 3 (40mg) - 3 patients will be entered and a standard 3 + 3 design will be implemented. De-escalation to inbetween doses can also be implemented on the advice of the IDSMB. The study will continue until MTD or the recommended Phase II dose is reached.
At this point Part B of the study will be initiated. Part B will enter patients of specified tumour types which will be identified during Part A of the study.REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0519
Date of REC Opinion
19 Nov 2013
REC opinion
Further Information Favourable Opinion