drugset / Trial / NCT02249429
Open-Label, Non Randomized Phase 2 Study With Safety Run-In
Phase 2
Completed
53 enrolled
PIQUR Therapeutics AG
Churchill Hospital · collabClinical Center Kragujevac · collabClinical Center Nis, Nis · collabInstitut Curie · collabInstitute for Oncology and Radiology Serbia, Belgrade · collabRoyal Marsden NHS Foundation Trust · collabUniversity Clinical Center, Sarajevo · collabUniversity Clinical Centre of Republic of Srpska · collabUniversity College London Hospitals · collabUniversity of Haifa · collabWeill Medical College of Cornell University · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-05
- Primary completion
- 2018-09-11
- Completion
- 2018-09-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bimiralisib | Small molecule | 60 mg | Oral |
| Subject | Bimiralisib | Small molecule | 80 mg | Oral |
| Subject | Bimiralisib | Small molecule | 120 mg | Oral |
| Subject | Bimiralisib | Small molecule | 140 mg | Oral |
| Subject | Bimiralisib | Small molecule | 160 mg | Oral |