Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
Cancer-Related Syndrome
Hematopoietic Malignancies
Leukemia
Myelodysplastic Syndromes (MDS)
18 - 130 Years, Male and Female
D8241C00001 (primary)
NCI-2021-08915
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.
Objectives
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.
Eligibility
- Diagnosis of acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL), or intermediate or higher risk myelodysplastic syndrome (MDS; Part A only), which is histologically proven based on criteria established by the World Health Organization (WHO) as documented by medical records. for which there are limited treatment options known to provide clinical benefit.
- Eastern cooperative oncology group performance status =2. Performance status must not have deteriorated by =2 levels within 2 weeks after providing informed consent.
- Predicted life expectancy =8 weeks.
- Adequate organ function at screening as per the protocol defined criteria.
- Adequate cardiac function as demonstrated by LVEF > 50% on screening cardiac multigated acquisition, magnetic resonance image or echocardiogram.
- Willing and able to participate in all required study evaluations and procedures including receiving IV administration of study treatment and admission to the hospital, when required, for administration of study treatment and monitoring.
- For inclusion in the genetic component of the study, participants must fulfil protocol defined criteria.
- White blood cell count must be <10 x 10^9/L prior to the first dose in Cycle 1, Day 1. Treatment with hydroxyurea during screening and Cycle 1 to control white blood cell count is permitted.
- Women of childbearing potential and men should use protocol defined contraceptive measures.
Treatment Sites in Georgia
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