PQR309-005_Efficacy and safety study of PQR309 in primary CNS lymphoma
Research type
Research Study
Full title
Open-label, non randomized, phase 2 study evaluating efficacy and safety of PQR309 in patients with relapsed or refractory primary CNS lymphoma
IRAS ID
220213
Contact name
Graham Collins
Contact email
Sponsor organisation
PIQUR Therapeutics AG
Eudract number
2015-001306-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 2 days
Research summary
Primary central nervous system lymphoma (PCNSL) is an aggresive, rare lymphoma that may affect the brain, spinal cord, meninges and eyes. The incidence of PCNSL patients has been increasing over the last 30 years; the increase is evident in all age groups and in both genders. PCNSL occurs in both immunocompetent and immunocompromised patients.
Although there are some treatment regimens (mainly chemotherapy), treatment options for patients with PCNSL are limited, the prognosis is poor and there is a critical need to develop novel agents that improve the current treatment options.
PQR309 works by blocking a signal path inside the tumor cell, which is essential for tumor cell growth. The signal that is designed to block is called the PI3K/mTor pathway. Various studies have shown that PQR309 can slow the growth of cancer cells.
Study PQR309-005 is an open-label phase 2 study in patients with PCNSL. The main objective is to evaluate the clinical efficacy of PQR309 in this indication. All patients will be treated with PQR309 orally. There will be two stages in the study. In the first stage, different treatment regimens will be evaluated, and a dose regimen will be selected for the second stage.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0126
Date of REC Opinion
19 May 2017
REC opinion
Further Information Favourable Opinion