Milademetan

Generic Name: Milademetan

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₃₄Cl_₂FN_₅O_₄

CAS Number: 1398568-47-2

Unique Ingredient Identifier: R3I80TLN7S

Background: Milademetan is under investigation in clinical trial NCT02319369 (Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)).

Clinical Trials

Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss

Phase 1

Withdrawn

Conditions: Advanced Solid Tumor
Urothelial Carcinoma Bladder
Melanoma
Gastric Cancer
CDKN2A
NSCLC
HNSCC
Renal Cell Carcinoma
Mesothelioma
Pancreas Adenocarcinoma

Interventions: Drug: Milademetan
Drug: Atezolizumab

First Posted Date: 2023-10-19

Last Posted Date: 2023-10-19

Lead Sponsor: Rain Oncology Inc

Registration Number: NCT06090318

Milademetan and Fulvestrant in GATA3-mutant, ER+HER- Advanced or Metastatic Breast Cancer

Phase 2

Terminated

Conditions: Advanced or Metastatic Breast Cancer

Interventions: Drug: Milademetan
Behavioral: Patient Reported Outcomes (PROs) and Health-Related Quality of Life (HRQOL)

First Posted Date: 2023-07-06

Last Posted Date: 2023-12-21

Lead Sponsor: Institut Curie

Target Recruit Count: 1

Registration Number: NCT05932667

Locations: 🇫🇷
Institut Du Cancer Montpellier, Montpellier, France
🇫🇷
Institut Curie, Saint-Cloud, France
🇫🇷
Centre Eugene Marquis, Rennes, France

and more 2 locations

A Study of Milademetan Administration on Cardiac Repolarization in Healthy Subjects

Phase 1

Terminated

Conditions: Cardiac Repolarization

Interventions: Drug: Placebo
Drug: Moxifloxacin (positive control)
Drug: Milademetan

First Posted Date: 2023-03-07

Last Posted Date: 2023-08-08

Lead Sponsor: Rain Oncology Inc

Target Recruit Count: 6

Registration Number: NCT05758818

Locations: 🇦🇺
Nucleus Network Melbourne, Melbourne, Victoria, Australia

Milademetan in Advanced/Metastatic Solid Tumors

Phase 2

Terminated

Conditions: Solid Tumors
Head and Neck Carcinoma
Cholangiocarcinoma
Sarcoma
Lung Adenocarcinoma
Ovarian Carcinoma
Gastric Cancer
Bladder Urothelial Carcinoma
Stomach Adenocarcinoma
Breast Cancer Invasive

Interventions: Drug: RAIN-32

First Posted Date: 2021-08-19

Last Posted Date: 2024-10-17

Lead Sponsor: Rain Oncology Inc

Target Recruit Count: 40

Registration Number: NCT05012397

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

and more 10 locations

Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

Phase 3

Terminated

Conditions: Dedifferentiated Liposarcoma

Interventions: Drug: RAIN-32
Drug: Trabectedin

First Posted Date: 2021-07-28

Last Posted Date: 2025-01-14

Lead Sponsor: Rain Oncology Inc

Target Recruit Count: 175

Registration Number: NCT04979442

Locations: 🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States
🇺🇸
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

and more 68 locations

Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Milademetan

First Posted Date: 2018-09-14

Last Posted Date: 2023-11-07

Lead Sponsor: Daiichi Sankyo Co., Ltd.

Target Recruit Count: 14

Registration Number: NCT03671564

Locations: 🇯🇵
Kyusyu University Hospital, Fukuoka, Japan
🇯🇵
Tenri Hospital, Nara, Japan
🇯🇵
Gifu Municipal Hospital, Gifu, Japan

and more 5 locations

Food Effects on Milademetan Pharmacokinetics in Healthy Participants

Early Phase 1

Completed

Conditions: Food Effects on Pharmacokinetics

Interventions: Drug: Milademetan Treatment A
Drug: Milademetan Treatment B
Drug: Milademetan Treatment C

First Posted Date: 2018-08-27

Last Posted Date: 2019-02-12

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 18

Registration Number: NCT03647202

Locations: 🇺🇸
Covance Clinical Research Unit, Inc., Dallas, Texas, United States

Milademetan Tosylate and Low-Dose Cytarabine With or Without Venetoclax in Treating Participants With Recurrent or Refractory Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Milademetan Tosylate
Drug: Venetoclax

First Posted Date: 2018-08-16

Last Posted Date: 2023-06-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 16

Registration Number: NCT03634228

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants

Early Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Milademetan
Drug: Posaconazole
Drug: Itraconazole

First Posted Date: 2018-08-03

Last Posted Date: 2019-02-12

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 36

Registration Number: NCT03614455

Locations: 🇺🇸
Covance Clinical Research Unit, Inc., Dallas, Texas, United States

Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Quizartinib
Drug: Milademetan

First Posted Date: 2018-06-11

Last Posted Date: 2022-05-20

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 10

Registration Number: NCT03552029

Locations: 🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
🇺🇸
Duke University Cancer Center, Durham, North Carolina, United States

and more 5 locations

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