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Milademetan

DRUG9 trials

Sponsors

Institut Curie, Daiichi Sankyo, Daiichi Sankyo Co., Ltd., Rain Oncology Inc

Conditions

Acute Myelogenous LeukemiaAcute Myeloid LeukemiaAdvanced Solid TumorAdvanced or Metastatic Breast CancerCDKN2ACardiac RepolarizationER-positiveGATA3-mutant

Early Phase 1

Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants
CompletedNCT03614455
Daiichi SankyoPharmacokinetics
Start: 2018-07-13End: 2018-10-01Updated: 2019-02-12

Phase 1

A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas
CompletedNCT01877382
Daiichi SankyoAdvanced Solid Tumor, Lymphoma
Start: 2013-07-11End: 2020-12-03Updated: 2025-03-27
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
TerminatedNCT02319369
Daiichi SankyoAcute Myelogenous Leukemia, Myelodysplastic Syndrome
Start: 2014-11-25End: 2020-08-21Updated: 2021-10-11
Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)
TerminatedNCT03552029
Daiichi SankyoAcute Myeloid Leukemia
Start: 2018-12-12End: 2021-04-01Updated: 2022-05-20
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
CompletedNCT03671564
Daiichi Sankyo Co., Ltd.Acute Myeloid Leukemia
Start: 2018-08-23End: 2019-09-11Updated: 2023-11-07
A Study of Milademetan Administration on Cardiac Repolarization in Healthy Subjects
TerminatedNCT05758818
Rain Oncology IncCardiac Repolarization
Start: 2023-04-17End: 2023-06-08Updated: 2023-08-08
Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
WithdrawnNCT06090318
Rain Oncology IncAdvanced Solid Tumor, CDKN2A, Gastric Cancer +7
Start: 2023-05-19End: 2023-05-30Updated: 2023-10-19

Phase 2

"DEMETER": Milademetan and fulvestrant in GATA3-mutant, ER-positive, HER2-negative advanced or metastatic breast cancer patients: a multicenter phase II trial
CompletedCTIS2022-502360-21-00
Institut CurieER-positive, GATA3-mutant, HER2-negative advanced or metastatic breast cancer
Start: 2023-10-12End: 2023-11-24Target: 48Updated: 2023-06-06
Milademetan and Fulvestrant in GATA3-mutant, ER+HER- Advanced or Metastatic Breast Cancer
TerminatedNCT05932667
Institut CurieAdvanced or Metastatic Breast Cancer
Start: 2023-10-12End: 2023-11-30Updated: 2023-12-21

Related Papers

Synergistic Activity of Combined FLT3-ITD and MDM2 Inhibition with Quizartinib and Milademetan in <i>FLT3</i> -ITD Mutant/ <i>TP53</i> Wild-type Acute Myeloid Leukemias
Clinical Cancer Research2025-05-061 citations
Abstract P6-10-10: Genetic alterations in breast cancer associated with MDM2 dependency and sensitivity to the MDM2 inhibitor milademetan
Cancer Research2023-03-01
Abstract P210: MDM2 gene amplification as a predictive biomarker for the MDM2 inhibitor milademetan
Molecular Cancer Therapeutics2021-12-01
Single-Cell Proteomics Identifies Leukemia Landscape Associated with Clinical Outcomes in R/R AML Treated with MDM2i (Milademetan) and FLT3i (Quizartinib): Putative Role of CD68 and Diversity Index
Blood2021-11-051 citations
Model‐based assessments of CYP3A‐mediated drug‐drug interaction risk of milademetan
Clinical and Translational Science2021-06-039 citations
Clonal Expansion of Mutant p53 Clones By MDM2 Inhibition in Acute Myeloid Leukemias
Blood2020-11-042 citations
A Phase 1 Dose Escalation Study of Milademetan in Combination with 5-Azacitidine (AZA) in Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Blood2019-11-134 citations
A Phase 1 Study of Milademetan in Combination with Quizartinib in Patients with Newly Diagnosed (ND) or Relapsed/Refractory (R/R) FLT3-ITD Acute Myeloid Leukemia (AML)
Blood2019-11-131 citations
A phase I study of milademetan in combination with quizartinib in patients (pts) with newly diagnosed (ND) or relapsed/refractory (R/R) <i>FLT3</i>-ITD acute myeloid leukemia (AML).
Journal of Clinical Oncology2019-05-203 citations
A phase 1 study of MDM2 inhibitor DS-3032b in patients with well/de-differentiated liposarcoma (WD/DD LPS), solid tumors (ST) and lymphomas (L).
Journal of Clinical Oncology2018-05-2043 citations
Phase 1 Dose Escalation Study of MDM2 Inhibitor DS-3032b in Patients with Hematological Malignancies - Preliminary Results
Blood2016-12-0237 citations
A phase 1 study of the MDM2 inhibitor DS-3032b in patients (pts) with advanced solid tumors and lymphomas.
Journal of Clinical Oncology2016-05-2023 citations
Abstract B27: A phase I dose escalation study of the MDM2 inhibitor DS-3032b in patients with advanced solid tumors and lymphomas
Molecular Cancer Therapeutics2015-12-015 citations