drugset / Trial / NCT01265199
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk Acute Myelogenous Leukemia (AML)
NaSingle-groupOpen-labelTreatment
Summary
The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406 works. Side effects will also be studied in an effort to make sure that this drug is safe to take.
Timeline
- Start
- 2011-02
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xevinapant | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Background | Daunorubicin | Small molecule | 90 mg/m2 | Intravenous |