Clinical Trials Using MDM2 Inhibitor DS-3032b
Clinical trials are research studies that involve people. The clinical trials on this list are studying MDM2 Inhibitor DS-3032b. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)
Participants with AML that have gone into remission and come back (relapsed) or gone into remission with a number of leukemia cells still in their system (refractory) will be recruited for this study. They will also be positive for FLT3-ITD mutation. Participants will receive a combined dose of quizartinib and milademetan that have not been approved by the US Food and Drug Administration yet (m). The combination of these drugs will be provided in different amounts on defined days (dosing schedules). It is expected that the combination of milademetan and quizartinib will be safe and well tolerated. It is expected that the combination may fight the leukemia better than a single drug. The study will run for approximately 3 years. There may be up to 156 participants. The study has 2 parts: - Part 1 will test approximately 24-36 participants in 10-12 study centers in the United States. Participants will receive two study drugs (milademetan and quizartinib) in different amounts on specific days. Information will be gathered to see what dosing schedule of the drug combination is best (maximum tolerated / recommended dose). - Part 2 of the study will confirm the recommended dosing schedule identified in Part 1 is effective. A larger number of participants will receive the recommended dose in up to an additional 15 sites worldwide as necessary, based on the enrollment rate, the population, and the standard of care available to them at the time.
Location: 8 locations
A Phase 1 Multiple Ascending Dose Study of DS-3032b, an Oral Murine Double Minute 2 (MDM2) Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas
This will be a Phase 1, open-label study of DS-3032b to assess its safety and tolerability, identify a maximum tolerated dose (MTD) / tentative recommended phase 2 dose (RP2D), and assess its pharmacokinetic (PK) / pharmacodynamic (PD) properties in subjects with advanced solid tumors or lymphomas. Approximately 5 US sites are planned for Part 1 (Dose Escalation). Approximately 10 US sites are planned for Part 2 (Dose Expansion).
Location: 3 locations
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
This study will take place in parts: - Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules - Dose Escalation (Part 1A): Participants receive milademetan in combination with AZA, with different dose schedules The recommended dose for Part 2 will be selected. - Dose Expansion (Part 2): After Part 1A, participants will receive the recommended Part 2 dose schedule. There will be three groups - those with: 1. refractory or relapsed AML 2. newly diagnosed AML unfit for intensive chemotherapy 3. high-risk MDS - End-of-Study Follow-Up: Safety information will be collected until 30 days after the last treatment. This is the end of the study. The recommended dose for the next study will be selected.
Location: 3 locations
Milademetan Tosylate and Low-Dose Cytarabine in Treating Participants with Recurrent or Refractory Acute Myeloid Leukemia
This phase I / II trial studies the side effects and best dose of milademetan tosylate and to see how well it works with cytarabine in treating participants with acute myeloid leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Milademetan tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving milademetan tosylate and low-dose cytarabine may work better in treating participants with recurrent or refractory acute myeloid leukemia.
Location: M D Anderson Cancer Center, Houston, Texas