Actively Recruiting
How [14C]-DSP-5336 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Patients With Advanced Blood Cancers
Led by Sumitomo Pharma America, Inc. · Updated on 2026-04-08
8
Participants Needed
2
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
How [14C]-DSP-5336 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Patients With Advanced Blood Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 years or older
- Female patients must be surgically sterile or postmenopausal
- Male patients must be permanently sterile or agree to use contraception
- Have an advanced hematologic malignancy that is relapsed, refractory, or progressed after standard treatments
- Prior treatment toxicities resolved to Grade 1 or less, except Grade 2 alopecia or neuropathy
- Adequate kidney and liver function
- ECOG performance status of 2 or less
- Able to attend required study visits including confinement for monitoring
- Able to understand and sign informed consent and follow study rules
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Clinically significant abnormal ECG, such as QTcF greater than 480 msec
- History of torsades de pointes
- Left ventricular ejection fraction of 45% or lower
- Conditions that increase risk or interfere with study results, including serious wounds, heart failure, unstable angina, treated arrhythmias (excluding asymptomatic atrial fibrillation), recent heart attack or acute coronary syndrome, or severe lung disease
- History of stomach or intestinal surgery affecting drug absorption (except uncomplicated appendectomy or hernia repair)
- Severe swallowing difficulties, malabsorption, or gastrointestinal diseases limiting oral drug intake
- Cognitive or psychological impairments affecting study compliance
- Recent bowel obstruction, abdominal fistula, gastrointestinal perforation, or abscess within 6 months unless approved
- Active uncontrolled infections requiring IV therapy
- Positive tests for active hepatitis or HIV infection
- Recent stem cell transplant, CAR-T therapy, or modified T-cell therapy within 60 days
- Recent donor lymphocyte infusion within 28 days, active graft-versus-host disease requiring treatment beyond topical steroids
- Recent use of systemic calcineurin inhibitors within 2 weeks
- Recent anticancer or investigational treatments within 14 days or 5 half-lives, whichever is shorter
- Major surgery within 28 days
- Known allergy to study drug components
- More than 2 prior radiolabeled drug studies in past 12 months or recent exposure within specified timeframes
- Poor peripheral venous access
- Exposure to significant radiation or radiation-monitored job within 12 months
- Investigator judgment that participation is not appropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Not Yet Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Holly Beever
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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