How [14C]-DSP-5336 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Patients With Advanced Blood Cancers

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSumitomo Pharma America, Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Histologic diagnosis of acute promyelocytic leukemia.

Abnormal ECG that is clinically significant, such as QTcF > 480 msec. QT interval correction can be performed in the case of bundle branch block.

History of torsades de pointes.

Left ventricular ejection fraction ≤ 45%, as determined by echocardiogram.

Trial design

Treatments tested in this trial

  • DSP-5336
  • [14C]-DSP-5336

Treatment groups

8 Participants
are divided into 2 treatment groups

Sponsors and collaborators