Table of Contents
- Trial overview
- Who can join the study
- What is being measured
- Study parts and treatment plan
- Trial phase and study size
Trial overview
This authorised interventional study is testing AZD3632 in adults with relapsed or refractory acute leukaemia or myelodysplastic syndromes with HOX overexpression genotypes.[1] The trial is designed to learn about safety, tolerability, early signs of benefit, and how the treatment moves through the body over time.[1]
The study is in Phase 1/2, which means it is an early trial that first focuses on safety and dose, while also starting to look at whether the treatment may help people with these blood cancers.[1]
Who can join the study
The target population includes adults with relapsed disease, meaning the cancer came back after treatment, or refractory disease, meaning the cancer did not respond well to treatment.[1] The study also includes people with myelodysplastic syndromes that have HOX overexpression genotypes, which means a specific gene pattern is present.[1]
These details show that the trial is aimed at people with advanced haematologic malignancies, which is a medical term for cancers of the blood and bone marrow.[1]
What is being measured
The main safety goal in Module 1 is to measure the incidence of dose-limiting toxicity during the dose-limiting toxicity evaluation period.[1] This means the researchers are checking whether side effects become serious enough to limit treatment.[1]
Both Module 1 and Module 2 measure the frequency of dose modifications, delays, and discontinuations because of adverse events.[1] They also measure treatment-emergent adverse events, treatment-related adverse events, and serious adverse events.[1]
The study also tracks changes from baseline in laboratory tests, 12-lead ECGs, performance status, physical examination findings, and vital signs.[1] In simple terms, the researchers are watching blood tests, heart tracing tests, general daily functioning, body checks, and basic body measurements to see how participants are doing during the trial.[1]
Study parts and treatment plan
Module 1 studies AZD3632 monotherapy, which means AZD3632 is given by itself.[1] In this part, the study aims to assess safety and tolerability and to identify the optimal biologic dose.[1]
Module 2 studies AZD3632 when it is co-administered with posaconazole, meaning the two treatments are given together.[1] In this part, the main safety goal is to assess safety and tolerability of the combination.[1]
The trial title also states that researchers want to learn how AZD3632 moves throughout the body over time, which is a way of studying how the treatment behaves in the body during the trial.[1]
Trial phase and study size
This is a single interventional study with a planned enrollment of 60 participants.[1] The authorised status shows that the study has been approved to proceed.[1]
Because the study is early phase, it is mainly designed to gather safety information and help researchers choose the best dose for future research.[1] It also begins to collect early signs of whether AZD3632 may help people with these specific blood cancers.[1]
