WHO ICTRP trial

Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 as Monotherapy…

EUCTR2018-003857-73-GB · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2018-003857-73-GB
Public title Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 as Monotherapy or in Combination in Myeloid Leukemia Patients.
Scientific title A Phase I/II, Open-Label, Multicentre 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 as Monotherapy or in Combination in Treatment-Naïve or Relapsed/Refractory Acute Myeloid Leukaemia Patients Not Eligible for Intensive Induction Therapy
Primary sponsor AstraZeneca AB
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries France;United States;Spain;Germany;Italy;United Kingdom
Conditions Treatment Naïve or Relapsed/Refractory Acute Myeloid Leukemia;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Product Name: AZD2811 suspension for constitution for infusion Product Code: AZD2811 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: AZD2811 CAS Number: 786684-28-4 Current Sponsor code: AZD2811 Concentration…
Registration date Mar 4, 2019
Target size 130
Secondary IDs D6130C00003;NCT03217838;HEMREF 41
Registry page clinicaltrialsregister.eu

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