A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of DSP-5336 Following a Single Oral Dose in Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Myeloproliferative Neoplasms
Sumitomo Pharma America, Inc.
Summary
The purpose of this study is to evaluate the absorption, metabolism, and excretion of DSP-5336 following a single oral administration of the study drug in patients with hematologic malignancies whose disease has progressed after available standard therapies.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female, of any race, ≥ 18 years of age. Female patients must be surgically sterile or postmenopausal. Male patients must be permanently sterile or agree to use contraception. * Have an advanced hematological malignancy that is relapsed, refractory, or has progressed following receipt of standard and available treatments. * Any prior pre-treatment toxicities resolved to ≤Grade 1 prior to enrolment, with exception of ≤Grade 2 alopecia or neuropathy. * Adequate kidney and liver function * ECOG performance status of ≤ 2. * Able to attend the required study visits, in…
Interventions
- DrugDSP-5336
tablet
- Drug[14C]-DSP-5336
oral solution
Locations (2)
- University of North CarolinaChapel Hill, North Carolina
- MD Anderson Cancer CenterHouston, Texas