Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.
Summary
This is a Phase I/II clinical study to determine the maximum tolerated dose (MTD), and schedule, safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD2811 monotherapy or with combination agent(s) in relapsed/refractory acute myeloid leukaemia (AML) participants or treatment-naïve AML participants not eligible for intensive induction therapy. In addition, the study will explore the potential clinical activity by assessing anti-tumour activity in participants. The study was terminated early as a result of AstraZeneca's strategic review across the AZD2811 programme. Part A data were collected for initial cohorts; the MTD/recommended Phase 2 dose (RP2D) dose and schedule of AZD2811 monotherapy or with combination agents were not determined. Part B of the study was not initiated
Timeline
- Start
- 2017-07-31
- Primary completion
- 2021-03-25
- Completion
- 2021-03-25
Outcome
Outcome not reported
Stopped (Business): “strategic decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZD2811 | Unknown | 200 mg | Intravenous |
| Subject | AZD2811 | Unknown | 300 mg | Intravenous |
| Subject | AZD2811 | Unknown | 400 mg | Intravenous |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Venetoclax | Small molecule | 200 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |