Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT02319369
Brief Summary:
This study will take place in parts:
* Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules
* Dose Escalation (Part 1A): Participants receive milademetan in combination with 5-azacytidine (AZA), with different dose schedules
The recommended dose for Part 2 will be selected.
* Dose Expansion (Part 2): After Part 1A, participants will receive the recommended Part 2 dose schedule. There will be three groups - those with:
1. refractory or relapsed acute myelogenous leukemia (AML)
2. newly diagnosed AML unfit for intensive chemotherapy
3. high-risk myelodysplastic syndrome (MDS)
* End-of-Study Follow-Up: Safety information will be collected until 30 days after the last treatment. This is the end of the study.
The recommended dose for the next study will be selected.
Detailed Description:
The primary analysis will occur after all participants have either discontinued the study or completed at least 6 months of treatment. After the primary analysis, the main study will be closed. Participants who are still on study at least 6 months after enrollment of the last participant in the study may be eligible to continue receiving study drug in a separate extension phase of the protocol
Study:
NCT02319369
Study Brief:
Protocol Section:
NCT02319369