Lymphoma, Malignant Clinical Trial
Official title:
Open-Label, Non Randomized Phase 2 Study With Safety Run-In Evaluating Efficacy and Safety of PQR309 in Patients With Relapsed or Refractory Lymphoma
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 bimiralisib (PQR309) administered orally, as once daily capsules continuously and on intermittent schedule in patients with relapsed or refractory lymphomas.
Open-label, non-randomized, multicentre phase 2 study with a safety run-in evaluating
efficacy and safety of bimiralisib (PQR309) in patients with relapsed or refractory lymphoma.
The maximum tolerated dose (MTD) of bimiralisib in patients with advanced solid tumors was
defined as 80 mg once daily given continuously (q.d. schedule) in a previous phase 1 study.
The safety run-in of this study will follow a modified 3 + 3 design to evaluate the safety of
60 and 80 mg bimiralisib 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 bimiralisib for 28 days.
Enrollment and treatment of all three patients may occur simultaneously as 80 mg bimiralisib
p.o. qd was established as the MTD in solid tumors. 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 bimiralisib, data emerge during step 1 of the phase 2 expansion in
this study, indicating that daily dosing of bimiralisib is not adequately tolerated or
inefficacious.
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