Spots Global Cancer Trial Database for A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)
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Trial Identification
Brief Title: A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)
Official Title: A Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of MK-0482 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
Study ID: NCT05038800
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and recommended Phase 2 dose (RP2D) of MK-0482. There are 2 parts of this study. Part 1 is a dose escalation which will follow an accelerated titration design (ATD) for participants with relapsed/refractory (R/R) AML or CMML. Part 2 is a dose expansion for participants with R/R AML.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Roswell Park Cancer Institute ( Site 0006), Buffalo, New York, United States
University of Texas MD Anderson Cancer Center ( Site 0004), Houston, Texas, United States
Hadassah Medical Center ( Site 0100), Jerusalem, , Israel
Sheba Medical Center-Hemato Oncology ( Site 0101), Ramat Gan, , Israel
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 0301), Salamanca, , Spain
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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