Clinical Trials Logo
  1. Home
  2. Myelofibrosis
  3. NCT03136185

Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)

Myelofibrosis Clinical Trial

Official title:
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis

Clinical Trial Summary

This is a Phase 1/2 open-label study to evaluate the safety, tolerability, steady-state pharmacokinetic (PK) and pharmacodynamics (PD) of a lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat (IMG-7289/MK-3543), administered orally once daily in participants with myelofibrosis. The primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with myelofibrosis including primary myelofibrosis (PMF), post-polycythaemia vera-myelofibrosis (PPVMF), and post-essential thrombocythaemia-myelofibrosis (PET-MF) (collectively referred to as 'MF'); inhibition of LSD1 by bomedemstat will reduce spleen size in those with splenomegaly, improve haematopoiesis and reduce constitutional symptoms associated with these disorders.

Clinical Trial Description

This study initiated as a Phase 1/2a study assessing the safety of the starting dose, an 85-day duration of treatment, and the PK and PD effects of bomedemstat, with transition to a Phase 2b study incorporating changes supported by the Phase 1/2a data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03136185
Study type Interventional
Source Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 18, 2017
Completion date March 8, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Not yet recruiting NCT06345495 - High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly Phase 2
Terminated NCT04866056 - Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF. Phase 1/Phase 2
Completed NCT02784496 - Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis Phase 2
Completed NCT00069680 - Genetic Analysis of Gray Platelet Syndrome
Active, not recruiting NCT04097821 - Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients Phase 1/Phase 2
Active, not recruiting NCT03289910 - Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Not yet recruiting NCT06397313 - RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis Phase 2
Not yet recruiting NCT06024915 - A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets Phase 1
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Completed NCT02910258 - Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis
Completed NCT00997386 - Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States Phase 2
Completed NCT00975975 - Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer Phase 2
Completed NCT00666549 - Research Tissue Bank
Terminated NCT00522990 - Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias Phase 1/Phase 2
Terminated NCT00393380 - Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor Phase 2
Completed NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants Phase 1
Active, not recruiting NCT03952039 - An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib Phase 3
Not yet recruiting NCT04709458 - Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis Phase 1