Last updated on April 2017

Open-Label Non Randomized Phase 2 Study With Safety Run-In


Brief description of study

The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of PQR309 administered orally, as once daily capsules continuously and now on intermittent schedule in patients with relapsed or refractory lymphomas.

Detailed Study Description

Open-label, non-randomized, multicentre phase 2 study with a safety run-in evaluating efficacy and safety of PQR309 in patients with relapsed or refractory lymphoma. The maximum tolerated dose (MTD) of PQR309 in patients with advanced solid tumours was defined as 80 mg once daily given continuously (q.d. schedule) in a previous phase 1 study [8]. The safety run-in of this study will follow a modified 3 + 3 design to evaluate the safety of 60 and 80 mg PQR309 in patients with relapsed or refractory lymphoma administered p.o. once daily during a DLT (dose-limiting toxicity) period of 28 days. In the safety run-in, three patients will be treated at 60 mg PQR309 for 28 days. Enrollment and treatment of all three patients may occur simultaneously as 80 mg PQR309 p.o. qd was established as the MTD in solid tumours. Unless a DLT is observed in any of the three patients during the first 28 days of treatment, the investigators and the sponsor will decide to escalate the dose to 80 mg.Intermittent dosing schedules may be evaluated if, based on the overall evaluation of all the clinical and PK (pharmacokinetic) data from this and other studies with PQR309, data emerge during the step 1 of the phase 2 expansion in this PQR309 002A study, indicating that daily dosing of PQR309 is not adequately tolerated or inefficacious. Intermittent dosing schedules may be evaluated if, based on the overall evaluation of all the clinical and PK data from this and other studies with PQR309, data emerge during the step 1 of the phase 2 expansion in this PQR309 002A study, indicating that daily dosing of PQR309 is not adequately tolerated or inefficacious.

Clinical Study Identifier: NCT02249429

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Sinisa Radulovic

Institute for Oncology and radiology of Serbia
Belgrade, Serbia
1.49miles
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Ivan Tijanic

Clinical Center Nis
Nis, Serbia
2.75miles
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