Description:
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and
pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute
myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the
milademetan dose will be made in the same participant. Dose-limiting toxicity associated with
milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD)
will be decided using a modified continuous reassessment method (mCRM).
Title
- Brief Title: Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Official Title: Phase 1, Open-label, Dose Escalation Study of Milademetan, an Oral MDM2 Inhibitor, to Assess Safety, Tolerability and Pharmacokinetics in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
Clinical Trial IDs
- ORG STUDY ID:
DS3032-A-J104
- SECONDARY ID:
184054
- NCT ID:
NCT03671564
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Milademetan | DS-3032b | Dose Escalation - Milademetan |
Purpose
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and
pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute
myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the
milademetan dose will be made in the same participant. Dose-limiting toxicity associated with
milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD)
will be decided using a modified continuous reassessment method (mCRM).
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation - Milademetan | Experimental | All participants enrolled for dose escalation receive a single oral dose of 90 mg milademetan, followed by escalated doses, based on mCRM with EWOC | |
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory AML
- AML for which no standard treatment is available
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
Exclusion Criteria:
- Acute Promyelocytic Leukemia
- Chronic myelogenous leukemia in blast crisis (BCR-ABL fusion gene positive)
- Presence of central nervous system involvement of leukemia or a history of primary
central nervous system leukemia
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants with Dose Limiting Toxicities (DLTs) |
Time Frame: | at approximately 28 days after start of treatment |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Maximum plasma concentration (Cmax) |
Time Frame: | Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) |
Safety Issue: | |
Description: | |
Measure: | Time to reach Cmax (Tmax) |
Time Frame: | Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) |
Safety Issue: | |
Description: | |
Measure: | Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast) |
Time Frame: | Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) |
Safety Issue: | |
Description: | |
Measure: | Trough plasma concentration (Ctrough) |
Time Frame: | Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Trial Keywords
- Oncology
- MDM2
- Escalation with overdose control (EWOC)
Last Updated
October 29, 2019