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

Active:	No
Cancer Type:	Cancer-Related Syndrome Hematopoietic Malignancies Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT04865419
Trial Phases:	Phase I	Protocol IDs:	D8241C00001 (primary) NCI-2021-08915
Eligibility:	18 - 130 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT04865419

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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