Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies

Haematological Malignancies Clinical Trial

Official title: A Modular Phase I/II, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies

Status Terminated

Clinical Trial Summary

The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of AZD0466 as monotherapy in partciapants with advanced haematological malignancies and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.

Clinical Trial Description

The study consists of 2 individual modules as: Module 1 (AZD0466 monotherapy), and Module 2 (DDI study of AZD0466 with voriconazole).

Eligible participants will be assigned to study treatments across Modules 1 and 2.

1. Module 1: AZD0466 monotherapy will include 2 parts- Part A dose escalation cohorts and Part B dose expansion cohorts. Initiation of Part B will depend on the evaluation of safety, tolerability, and PK in Part A.

2. Module 2: AZD0466 and voriconazole DDI study.

All participants will receive AZD0466, and administration will continue until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment. ;

Related Conditions & MeSH terms

• Haematological Malignancies
• Hematologic Neoplasms
• Neoplasms

• NCT number: NCT04865419
• Study type: Interventional
• Source: AstraZeneca
• Status: Terminated
• Phase: Phase 1
• Start date: June 11, 2021
• Completion date: August 8, 2023