DeepMed Research

Siremadlin

Generic Name: Siremadlin

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₄Cl_₂N_₆O_₄

CAS Number: 1448867-41-1

Unique Ingredient Identifier: 0282IF4JC8

Clinical Trials

Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: Siremadlin

First Posted Date: 2022-10-31

Last Posted Date: 2025-05-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 38

Registration Number: NCT05599932

Locations: 🇺🇸
Texas Liver Institute, San Antonio, Texas, United States
🇺🇸
Clinical Pharmacology of Miami LLC, Miami, Florida, United States
🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia
Allogeneic Stem Cell Transplantation

Interventions: Drug: Siremadlin

First Posted Date: 2022-07-07

Last Posted Date: 2025-05-16

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 8

Registration Number: NCT05447663

Locations: 🇪🇸
Novartis Investigative Site, Valencia, Spain

HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas

Phase 1

Recruiting

Conditions: Advanced Soft-tissue Sarcoma
Metastatic Soft-tissue Sarcoma

Interventions: Drug: Pazopanib
Drug: HDM201

First Posted Date: 2022-01-06

Last Posted Date: 2024-04-08

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 58

Registration Number: NCT05180695

Locations: 🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Institut Paoli-Calmettes, Marseille, France
🇫🇷
Institut Claudius Regaud, Toulouse, France

and more 2 locations

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: siremadlin
Drug: venetoclax
Drug: azacitidine

First Posted Date: 2021-12-14

Last Posted Date: 2025-04-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 14

Registration Number: NCT05155709

Locations: 🇺🇸
Oregon Health Sciences University, Portland, Oregon, United States
🇺🇸
Texas Oncology Sammons Cancer Center, Dallas, Texas, United States
🇹🇷
Novartis Investigative Site, Izmir, Turkey

HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.

Phase 1

Terminated

Conditions: AML, Adult

Interventions: Drug: HDM201
Drug: Midostaurin

First Posted Date: 2020-08-04

Last Posted Date: 2022-10-06

Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Target Recruit Count: 2

Registration Number: NCT04496999

Locations: 🇨🇭
Departement of Medical Oncology, University Hospital Berne, Berne, Switzerland

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/characteristics in Advanced / Metastatic Tumors.

Phase 2

Recruiting

Conditions: Malignant Solid Tumor

Interventions: Drug: Cabozantinib
Drug: Trametinib
Drug: HDM201
Drug: Regorafenib
Drug: Alectinib
Drug: Avapritinib
Drug: Ribociclib
Drug: Dabrafenib

First Posted Date: 2019-10-04

Last Posted Date: 2024-12-12

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 455

Registration Number: NCT04116541

Locations: 🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷
Institut Paoli Calmettes, Marseille, France

and more 5 locations

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Phase 1

Completed

Conditions: Myelofibrosis

Interventions: Drug: Ruxolitinib
Drug: Crizanlizumab
Drug: Sabatolimab
Drug: Siremadlin
Drug: NIS793
Drug: Rineterkib

First Posted Date: 2019-09-20

Last Posted Date: 2024-12-04

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 45

Registration Number: NCT04097821

Locations: 🇬🇧
Novartis Investigative Site, London, United Kingdom

HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)

Phase 1

Active, not recruiting

Conditions: High-risk Myelodysplastic Syndrome (MDS)
Acute Myeloid Leukemia (AML)

Interventions: Drug: HDM201
Drug: Venetoclax
Biological: MBG453

First Posted Date: 2019-05-07

Last Posted Date: 2024-07-03

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 52

Registration Number: NCT03940352

Locations: 🇪🇸
Novartis Investigative Site, Madrid, Spain
🇺🇸
Duke University Medical Center ., Durham, North Carolina, United States

HDM201 Added to CT in R/R or Newly Diagnosed AML

Phase 1

Withdrawn

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: HDM201
Drug: cytarabine
Drug: anthracycline
Drug: liposomal cytarabine/daunorubicin
Drug: posaconazole
Drug: midazolam
Drug: midostaurin

First Posted Date: 2018-11-30

Last Posted Date: 2020-01-09

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT03760445

Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type

Phase 1

Completed

Conditions: Colorectal Cancer
Advanced Cancer
Metastatic Cancer

Interventions: Drug: HDM201
Drug: Trametinib

First Posted Date: 2018-10-22

Last Posted Date: 2023-09-13

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 12

Registration Number: NCT03714958

Locations: 🇫🇷
Centre Leon Berard, Lyon, France

Drug Development Updates

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