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

NCT02249429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-09-06

No results posted yet for this study

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.

Conditions

  • Lymphoma, Malignant

Interventions

DRUG

bimiralisib

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.

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • Churchill Hospital

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • University of Haifa

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Institut Curie

    collaborator OTHER

  • University Clinical Center, Sarajevo

    collaborator UNKNOWN

  • Clinical Center Kragujevac

    collaborator OTHER

  • Clinical Center Nis, Nis

    collaborator UNKNOWN

  • Institute for Oncology and Radiology Serbia, Belgrade

    collaborator UNKNOWN

  • University Clinical Centre of Republic of Srpska

    collaborator OTHER

  • PIQUR Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • Rakesh Popat · Univeristy College London

  • David Cunningham · Royal Marsden NHS Foundation Trust

  • Paul Fields · Guy's Hospital

  • Graham Collins · Churchill Hospital

  • Netanel Horowitz · University of Haifa

  • Giulino Roth · Weill Cornell Medicine New York

  • Carole Soussain · Curie Institute

  • Sinisa Radulovic · Institute for Oncology and Radiology Serbia

  • Ivan Tijanic · Clinical Center Nis

  • Nebojsa Andjelkovic · Clinical Center Kragujevac

  • Sabrina Kurtovic · University Clinical Center, Sarajevo

  • Danijela Mandic · University Clinical Centre of Republic of Srpska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-09-11
Completion
2018-09-11
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • France
  • Israel
  • Serbia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02249429 on ClinicalTrials.gov