Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-05161 | Other Identifier | NCI-CTRP Clinical Trials Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs | Intra patient change in pharmacokinetic parameters will be determined. In addition, it will be evaluated whether crushing the tablet would have clinically significant change in AUC or Cmax, Tmax, which might impact efficacy or safety of belumosudil based on prior belumosudil pharmacokinetic studies. Due to small number of patients in this study, we don't plan to evaluate the impact of crushed belumosudil tablets pharmacokinetics with long-term outcomes. | Through study completion; an average of 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
MD Anderson Cancer Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amin Alousi, MD | Contact | (713) 745-8613 | aalousi@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Amin Alousi, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
Not provided
Not provided
Not provided
Not provided
Not provided
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |