Upcoming clinical trials
A Multicenter, Open-Label Study of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy
WPD Pharmaceuticals plans to start a multicenter, open-label, Phase 1b/2 efficacy and safety study of Berubicin utilizing a Simon's 2-stage design to confirm the efficacy (or futility) of a single arm of Berubicin treatment, administered at the recommended Phase 2 dose (RP2D) identified in Phase 1 studies (7.5 mg/m2 Berubicin HCl), on the endpoint of ORR in up to approximately 61 patients. A central reader will determine the radiologic responses for each patient according to m-RANO criteria. The responder criteria for this Simon's design will be based on objective response criteria defined as individual patients achieving CR or PR per m-RANO criteria within 6 months from baseline.
WPD-201 study is planned to start Patient enrollment in 4 Sites in Poland in Q3 2021.
For more information see
ClinicalTrials.gov Identifier: NCT04915404
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A Phase 1, Multicenter, Open-label, Dose Escalation Study of the Safety and Pharmacokinetics of Intravenously Infused Berubicin in Pediatric Patients with Progressive, Refractory, or Recurrent High Grade Gliomas
WPD Pharmaceuticals plans to start a multicenter, open-label, dose escalation Phase 1 study of intravenous Berubicin in pediatric patients. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and PK of Berubicin and to estimate its MTD and/or RP2D when administered to pediatric patients with progressive, refractory, or recurrent HGG who have completed at least 1 standard line of therapy. This study will also make a preliminary assessment of the antitumor activity of Berubicin in this patient population in up to approximately 35 patients. An exploratory evaluation of quality of life will also be performed.
This open-label, nonrandomized study is composed of a series of Dose Escalation Cohorts followed by an Expansion Cohort. The Dose Escalation Cohorts will utilize a standard “rules based” 3+3 design.
WPD-201P study is planned to start Patient enrollment in 2 Sites in Poland in Q3 2021.
For more information
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