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: 26 Apr 2017

At a glance

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

    • 07 Jun 2017 Biomarkers information updated
    • 02 Nov 2016 According to a Bio-Path Holdings media release, company reformat documents for this trial with the 60 mg/m2 dose and resubmit for approvals with the U.S. Food and Drug Administration (FDA) and site Institutional Review Boards, leads to additional time prior to starting this trial.
    • 02 Nov 2016 According to a Bio-Path Holdings media release, first patient has been enrolled and dosed in the efficacy portion of this trial. An interim analysis will be performed after after enrolment of 19 patients.Comapny may change this trial into a registration trial for accelerated approval if the interim results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds.
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