Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD
Not yet recruiting
- Conditions
- Chronic Graft Versus Host Disease
- Registration Number
- NCT07127926
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
The primary objective of the study is to evaluate belumosudil pharmacokinetics of whole tablets and crushed tablets suspended in water in patients suffering from chronic graft-versus-host disease (cGVHD).
- Detailed Description
Primary Objective:
To evaluate belumosudil pharmacokinetics of whole tablets and crushed tablets suspended in water in patients suffering from chronic graft-versus-host disease (cGVHD).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Male and female subjects ≥ 18 years of age with allogeneic HSCT
Exclusion Criteria
- Receiving an investigational GVHD treatment within 28 days of study entry; (2) active acute GVHD; and (3) taking any medication known to be CYP3A4 inducers.
- Pregnancy is an exclusion criterion for stem cell transplant. Pregnant women are not included in this study. Non-viable neonates will not be included in this study. Patients with cognitive impairments will not be included in this study. Patients aged less than 18 years old will not be included.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and adverse events (AEs Through study completion; an average of 1 year Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The University of Texas M. D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
The University of Texas M. D. Anderson Cancer Center🇺🇸Houston, Texas, United StatesAmin Alousi, MDPrincipal Investigator