Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

60 mg or 80 mg bimiralisib per oral (p.o.) once daily or intermittent dosing (120mg,140mg and 160mg) until unacceptable AE, disease progression, patient's request for withdrawal, investigator judgement or death - whichever comes first.

bimiralisib

Rakesh Popat

David Cunningham

Paul Fields

Graham Collins

Netanel Horowitz

Giulino Roth

Carole Soussain

Sinisa Radulovic

Ivan Tijanic

Nebojsa Andjelkovic

Sabrina Kurtovic

Danijela Mandic

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.

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

Open-Label, Non Randomized Phase 2 Study With Safety Run-In Evaluating Efficacy and Safety of PQR309 in Patients With Relapsed or Refractory Lymphoma

Continuous dosing and intermittent dosing

Radiological lymphoma Evaluation (CT or other indicated according to institutional standard practice), clinical examination and bone marrow biopsy

University College London Hospitals

Churchill Hospital

Royal Marsden NHS Foundation Trust

University of Haifa

Weill Medical College of Cornell University

Institut Curie

University Clinical Center, Sarajevo

Clinical Center Kragujevac

Clinical Center Nis, Nis

Institute for Oncology and Radiology Serbia, Belgrade

University Clinical Centre of Republic of Srpska

PIQUR Therapeutics AG

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks

Bimiralisib

Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 4 weeks

Natasa Cmiljanovic

Alexander Navarini

Olivier Gaide

The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands

This is a multi-center, randomized, open label, parallel group study. The study products will be applied to the target lesions for a duration of 2 or 4 weeks of treatment.

The study consists of the following periods:

* Screening (up to 30 days)
* Treatment (2 or 4 weeks)
* Follow-Up (4 weeks)

Participants will be randomized to one of two groups (1:1):

* Arm A: Topical bimiralisib gel treatment for 2 weeks
* Arm B: Topical bimiralisib gel treatment for 4 weeks

Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis

A Randomized Phase 2 Proof-of-Concept Study to Evaluate the Efficacy and Safety of Topical Bimiralisib Application in Participants Suffering From Actinic Keratosis on the Face and/or Scalp and/or Back of Hands Over a 2 and 4-week Treatment Period

Improvement from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale where 0 is complete clearance and 4 is no improvement)

Proportion of participants with partial (75% reduction in lesions) or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arm)

Safety endpoint assessed by treatment-emergent adverse events (including laboratory adverse events and vital signs)

Tolerability endpoint assessed by Investigator for specific local skin reactions using 4-point clinical scales for irritation, stinging/burning and pruritus.

Scales from 0 (no signs) to 3 (severe)

TORQUR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open-Label, Non Randomized Phase 2 Study With Safety Run-In	NCT02249429	Lymphoma, Malig...	bimiralisib	18 Years -	PIQUR Therapeutics AG
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis	NCT06319794	Actinic Keratos...	Bimiralisib Bimiralisib	50 Years -	TORQUR
Open-Label, Non Randomized Phase 2 Study With Safety Run-In	NCT02249429	Lymphoma, Malig...	bimiralisib	18 Years -	PIQUR Therapeutics AG

Spots Global Cancer Trial Database for bimiralisib

Every month we try and update this database with for bimiralisib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bimiralisib

Every month we try and update this database with for bimiralisib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bimiralisib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.