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Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

NCT02319369 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2021-10-11

Study results available
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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.

Conditions

Interventions

DRUG

Milademetan

Milademetan will be administered daily as oral capsules or as a combination of multiple oral capsules containing 5 mg, 20 mg, 80 mg, and/or 200 mg

DRUG

AZA

AZA will be administered at 75 mg/m\^2 subcutaneously or intravenously

DRUG

Milademetan

Milademetan will be administered daily as oral capsules or as a combination of multiple oral capsules containing 5, 20, 80, and/or 200 mg. An alternate combination of 30 mg, 80 mg, and/or 100 mg milademetan may be utilized.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-25
Primary Completion
2020-08-21
Completion
2020-08-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319369 on ClinicalTrials.gov