Phase III Study of Oral AZD3632 Alone or With Posaconazole for Advanced Blood Cancers with Specific Genetic Types

What this Trial Is About

Researchers are studying AZD3632, an oral drug, in people with advanced blood cancers such as acute leukemia and myelodysplastic syndromes MDS that have certain genetic changes linked to HOX gene overexpression. This early-phase, open-label study aims to understand the safety, side effects, how the drug is processed in the body, and preliminary effectiveness. The study is sponsored by AstraZeneca and includes participants whose disease has returned or not responded to standard treatments and who have no other approved therapy options. The trial has two parts. Module 1 tests different doses of AZD3632 alone to find a safe and tolerable dose in a dose-escalation design. Module 2 evaluates AZD3632 given together with another oral drug, posaconazole, to assess the safety and drug interactions. Participants receive their assigned AZD3632 dose or the combination during the treatment period. The study monitors participants until treatment discontinuation or as long as needed to assess outcomes. Participants will undergo regular assessments including blood tests, safety evaluations, and monitoring for side effects. Researchers will measure drug levels in the body over time and track response to treatment using specific criteria for blood cancers. Safety monitoring continues for up to about three years after treatment to record any adverse effects or complications. Overall survival, response rates, and other clinical outcomes will also be followed during this period to understand the drugs impact.

Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression