A Modular Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients With CD123-Positive Hematological Malignancies
- Conditions
- Hematological Malignancies
- Registration Number
- JPRN-jRCT2051230181
- Lead Sponsor
- Hibi Kazushige
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 96
18 years of age or more ;
- CD123+hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
- R/R AML;
- R/R HR-MDS with 5% or more bone marrow blast at time of inclusion;
- Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
- ECOG performance status of 2 or less.
The above is a summary, other inclusion criteria details may apply.
- Active CNS leukemia;
- Previous treatment with any CD123 targeting therapy;
- Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
- Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
- History of other malignancy(with certain exceptions);
- Active and uncontrolled infections;
- Unresolved AEs 2 Grade or more, from prior therapies.
The above is a summary, other exclusion criteria details may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Frequency of dose limiting toxicities (DLTs). [ Time Frame: Module 1 - 28 days. ]<br>DLTs are dose-limiting toxicities as defined in the study protocol.<br><br>2. Safety evaluation of AZD9829: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Module 1 - From informed consent until 30 days after last dose of AZD9829. ]<br>Frequency, severity and relationship to study drug of AEs and SAEs
- Secondary Outcome Measures
Name Time Method