A Phase IIa Single-arm, Open-label, Two-stage Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Low-dose Cytarabine (LDAC) in Patients With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Induction Therapy

Trial Profile

A Phase IIa Single-arm, Open-label, Two-stage Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Low-dose Cytarabine (LDAC) in Patients With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Induction Therapy

Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Apr 2018

At a glance

  • Drugs Prexigebersen (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Sponsors Bio-Path Holdings
  • Most Recent Events

    • 03 Apr 2018 According to a Bio-Path Holdings media release, the investigators of this study endorse the inclusion of a decitabine cohort based on relatively new and positive data with this compound.
    • 03 Apr 2018 According to a Bio-Path Holdings media release, the company is amending a protocol to change the dosing schedule to that used in the Phase 1b study.
    • 03 Apr 2018 Interim analysis results (n=17) published in a Bio-Path Holdings Media Release.
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