Safety and Tolerability of AZD1208 and the Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients

Titre officiel

A Phase Ia/Ib, Open-Label, Multicentre, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 Administered Daily in Adult Patients With Recurrent or Refractory Acute Myelogenous Leukemia (AML)

Sommaire:

Cette étude ouverte a pour but d’évaluer l’innocuité, la tolérabilité, les propriétés pharmacocinétiques et l’efficacité de l’AZD1208 chez des patients atteints d’une leucémie aiguë myéloïde (LAM) récidivante ou réfractaire. L’étude sera divisée en deux parties. Dans la partie A, les patients recevront des doses croissantes d’AZD1208 afin d’en déterminer la dose maximale tolérée. Dans la partie B, l’efficacité de la dose maximale tolérée sera évaluée dans un groupe élargi de patients porteurs de biomarqueurs précis.

Description de l'essai

Primary Outcome:

• Part A: Number of patients with dose limiting toxicities (DLTs) [Maximum Tolerated Dose (MTD) is defined as the maximum dose level below the dose level at which ≥ 33 % of at least 6 patients of a cohort experience DLTs during cycle 1.]
• Part B: Number of patients with Complete Remission (CR) or CR with incomplete blood count recovery (CRi)

Secondary Outcome:

• Part A and B: Number of patients with adverse events and serious adverse events
• Part A and B: Description of the pharmacokinetics (PK) of AZD1208 in terms of area under plasma concentration-time curve(AUC), maximum plasma concentration (Cmax), and time to maximum plasma concentration (Tmax)
• Part A and B: Description of urine pharmacokinetics (PK) of AZD1208 in terms of the cumulative amount of drug excreted unchanged into urine from zero to time and renal clearance
• Part A and B: Number of patients with response of Complete Remission(CR), CR with incomplete blood count recovery, Partial Remission, or Morphologic Leukemia-Free
• Part B: Duration of CR or CRi based on time from first documentation of CR to relapse

A Phase Ia/Ib, Open-Label, Multicentre, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 Administered Daily in Adult Patients with Recurrent or Refractory Acute Myelogenous Leukemia (AML).

Voir cet essai sur ClinicalTrials.gov