Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
Launched by SDK THERAPEUTICS, INC. · Mar 14, 2025
Trial Information
Current as of July 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new oral form of arsenic trioxide, a medication used to treat Acute Promyelocytic Leukemia (APL), a type of blood cancer. The trial aims to understand how the body processes this new oral medication when taken on an empty stomach compared to after eating, and how it compares to the traditional intravenous (IV) form of arsenic trioxide. This research is important because it could help improve treatment options for patients with APL.
To participate in this trial, individuals need to be diagnosed with APL, specifically those who have a genetic change known as the t(15;17) translocation. Unfortunately, those who have had a relapse or who do not respond to treatment for APL cannot join. Participants in the trial will take the oral medication and may be required to follow specific guidelines about eating before their doses. This study is currently looking for volunteers aged 65 to 74, and it welcomes both men and women. Being part of this trial could help advance our understanding of APL treatments and potentially benefit future patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • -Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression
- Exclusion Criteria:
- • Relapsed or refractory APL
About Sdk Therapeutics, Inc.
SDK Therapeutics, Inc. is a biopharmaceutical company dedicated to advancing innovative therapies for the treatment of serious medical conditions. With a strong focus on research and development, SDK Therapeutics harnesses cutting-edge science and technology to create novel therapeutic solutions that address unmet clinical needs. The company's commitment to improving patient outcomes is reflected in its robust pipeline of clinical trials, driven by a team of experienced professionals dedicated to excellence in drug development and regulatory compliance. Through strategic collaborations and a patient-centric approach, SDK Therapeutics aims to bring transformative therapies to market, enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hong Kong, , Hong Kong
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported