BridgeMD
New treatment option for Advanced Hematologic Malignancies
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
ClinicalTrials.gov ID: NCT07444268
What this study is testing
What is DSP-5336?
DSP-5336 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced hematologic malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, of any race, ≥ 18 years of age. Female patients must be surgically sterile or postmenopausal. Male patients must be permanently...
- 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.
You likely can't join if
- 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.
- Have any concurrent conditions that could pose an undue risk or interfere with interpretation of the study results, including, but not limited to...
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs...
See the full eligibility 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, including the confinement period for monitoring and collection of bowel movements and micturition.
- Able to comprehend and are willing to sign the ICF and abide by the study restrictions.
- 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.
- Have any concurrent conditions that could pose an undue risk or interfere with interpretation of the study results, including, but not limited to clinically significant non-healing or healing wounds, concurrent...
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
- History or evidence of severe dysphagia, short-gut syndrome, gastroparesis, gastrointestinal tract disease, malabsorption syndrome, the requirement for intravenous alimentation, gastric/jejunal feeds, any uncontrolled...
- Have cognitive, psychological, or psychosocial impediment that would impair their ability to receive therapy according to the protocol or would adversely affect their ability to comply with the informed consent process...
- History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of check-in, unless approved by the investigator and medical monitor.
- Active and uncontrolled bacterial, viral, or fungal infection requiring parenteral therapy.
- Positive hepatitis panel and/or positive human immunodeficiency virus test indicative of active infection. Patients whose results are compatible with prior immunization may be included.
- Undergone HSCT, chimeric antigen receptor cell therapy, or other modified T-cell therapy within 60 days prior to dosing.
- Received donor lymphocyte infusion within 28 days prior to dosing, receiving immunosuppressive therapy post-HSCT, or have clinically active GVHD or GVHD requiring active medical intervention other than the use of...
- Received systemic calcineurin inhibitors within 2 weeks prior to dosing.
- Received other anticancer drugs or other investigational treatment within 14 days or 5 half-lives, whichever is shorter, prior to dosing.
- Major surgery within 28 days prior to dosing.
- Any known intolerance or hypersensitivity to components of the study intervention.
- Patients who have previously been dosed in \> 2 radiolabeled drug studies in the last 12 months. For patients who have previously been dosed in ≤ 2 radiolabeled drug studies within the last 12 months, the previous...
- Poor peripheral venous access.
- Patients with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Patients who, in the opinion of the investigator or designee, should not participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.