Spots Global Cancer Trial Database for Open-Label, Non Randomized Phase 2 Study With Safety Run-In

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Trial Identification

Brief Title: Open-Label, Non Randomized Phase 2 Study With Safety Run-In

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

Study ID: NCT02249429

Conditions

Lymphoma, Malignant

Interventions

bimiralisib

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Non Hodgkin Lymphoma

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Weill Cornell Medicine, New York, New York, United States

University Clinical Center Republic of Srpska, Banja Luka, , Bosnia and Herzegovina

University Clinical Center Sarajevo, Sarajevo, , Bosnia and Herzegovina

Insitute Curie, Saint-Cloud, Paris, France

Univeristy Hospital Haifa, Haifa, , Israel

Institute for Oncology and radiology of Serbia, Belgrade, , Serbia

Clinical Center Kragujevac, Kragujevac, , Serbia

Clinical Center Nis, Nis, , Serbia

Guy's Hospital, London, , United Kingdom

Royal Marsden NHS Foundation Trust, London, , United Kingdom

University College Hospital London, London, , United Kingdom

Churchill Hospital, Oxford, , United Kingdom