Evaluating oral arsenic trioxide for treating acute promyelocytic leukemia
A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) Under Fasting and Fed Conditions, to Compare to Intravenous Arsenic Trioxide, and to Evaluate Interaction With Calcium Carbonate in Patients With Acute Promyelocytic Leukemia.
This study is testing if taking arsenic trioxide by mouth can be as effective as getting it through an IV for people with acute promyelocytic leukemia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SDK Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06882031 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics of an oral arsenic trioxide solution under both fasting and fed conditions, comparing its effectiveness to intravenous arsenic trioxide in patients with acute promyelocytic leukemia (APL). It is a randomized, open-label trial that includes multiple treatment arms to assess how the oral solution performs in different states. The goal is to determine the best administration method for improving patient outcomes in APL treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with acute promyelocytic leukemia characterized by specific genetic markers.
Not a fit: Patients who have relapsed or refractory acute promyelocytic leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more convenient and effective oral treatment option for patients with acute promyelocytic leukemia.
How similar studies have performed: While this approach is novel in the context of oral arsenic trioxide for APL, similar pharmacokinetic studies have shown promise in other treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- The University of Hong Kong-Clinical Trial Centre Phase 1 Centre — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Danelle James, MD
- Email: danelle.james@sdktx.net
- Phone: 619-606-3187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.