Evaluate safety & efficacy of AZD2811 as Monotherapy or as Combination

• Research type

  Research Study

• Full title

  A Phase I/II, Open-Label, Multicentre 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticle as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia Patients Not Eligible for Intensive Induction Therapy

• IRAS ID

  269213

• Contact name

  Jonathan Kell

• Contact email

  Jonathan.Kell@wales.nhs.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2018-003857-73

• Clinicaltrials.gov Identifier

  NCT03217838

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 6 months, 3 days

• Research summary

  This is a Phase I/II clinical study to determine the maximum tolerated dose (MTD), safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD2811 with or without azacitidine in patients with relapsed AML or treatment-naïve patients not eligible for intensive induction therapy. The study will also explore the potential clinical activity by assessing anti-tumour activity in patients. The study will be conducted in two parts, designated Part A, dose escalation, and Part B, dose expansion

• REC name

  HSC REC A

• REC reference

  19/NI/0155

• Date of REC Opinion

  26 Sep 2019

• REC opinion

  Further Information Favourable Opinion