Eric Stephen Winer, MD
Eric Stephen Winer, MD
The goal of this research study is to find the safest and most effective dose of the study drug, BXCL701, for the treatment of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). The names of the study drugs involved in this study are/is: BXCL701
Acute Myeloid Leukemia
Myelodysplastic Syndrome With Excess Blasts-2
BXCL701
Phase 1
This is a multi-center, single-arm, Phase I research study for the study drug, BXCL701, for participants with refractory or relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome with Excess Blasts-2 (MDS-EB-2). Phase I clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means the drug is being studied. BXCL701 is a synthetic dipeptide that is in tablet form and is taken by mouth. The U.S. Food and Drug Administration (FDA) has not approved BXCL701 as a treatment for any disease. Research study procedures include screening for eligibility and study treatment including evaluations, blood collections, bone marrow biopsies, and follow up visits. Participation in this study will last approximately 3 years. It is expected that about 24 people will participate in this study. BioXcel is supporting this research study by providing the study drug and funding research tests and procedures.}}
Study Type : | Interventional |
Estimated Enrollment : | 24 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Phase 1 Study of BXCL701 in Relapsed/Refractory Acute Myeloid Leukemia or Relapsed/Refractory Myelodysplastic Syndrome With Excess Blasts - 2 |
Actual Study Start Date : | February 2, 2023 |
Estimated Primary Completion Date : | July 31, 2024 |
Estimated Study Completion Date : | July 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation BXCL701 Dose escalation will occur using a 3+3 dose escalation approach, evaluating 4 different dose levels of BXCL701. During each 28 day study cycle participants will take BXCL701 2x daily for up to 12 cycles. |
Drug: BXCL701 |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215