Trial · NCT07296445
A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)
NCT07296445, Phase 3, Not yet recruiting, SDK Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301). Trials, record NCT07296445. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07296445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)
- NCT number
- NCT07296445
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 120 participants, estimated
- Lead sponsor
- SDK Therapeutics, Inc.
- Conditions
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA, APL, Acute Promyelocytic Leukemia, Leukaemia, Leukemia Acute Promyelocytic Leukemia (APL), Leukemia, Acute
- Interventions
- Oral ATO, IV Arsenic Trioxide, all-trans retinoic acid (ATRA)
- First posted
- 2025-12-22
- Last updated
- 2025-12-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetic exposure (amount of ATO in the blood) | At the end of Cycle 4, Week 1 (Each cycle is 8 weeks) | Total 5-dose plasma AsIII AUC |
| Secondary | Molecular Complete Response (molCR) rate | At the end of 3 Cycles of treatment (each cycle is 8 weeks) | molCR rate, defined as negative/undetected for PML:RARα by RT-qPCR |
| Secondary | Relapse-Free Survival (RFS) | Assessed for up to 2 years after the first dose of treatment, or until disease progression/relapse or death, whichever occurs first. | 2-year Relapse Free Survival (RFS) |
| Secondary | Change in Fridericia-corrected QT interval (ΔQTcF interval) | At the end of Cycles 3 and 4 (each cycle is 8 weeks) | Difference in QTcF between collected values |
| Secondary | Adverse events | Up to 9 months | Frequency, severity, and relatedness of adverse events. |
| Secondary | Cardiac AEs related to elevated QTcF | Up to 9 months | Number of prolonged QTcF interval or other arrhythmias per CTCAE |
| Secondary | Pharmacokinetic profile | At the end of Cycle 4, week 1 (Each cycle is 8 weeks) | Peak Plasma Concentration (Cmax) |
| Secondary | Patient Reported Outcomes | Up to 9 months | Change from baseline as measured by the EORTC QLQ-C30 |
| Secondary | Patient Reported Outcomes | Up to 9 months | Proportion of time "bothered by side-effects" as measured by the FACT-GP5 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07296445
GET https://conductscience.org/api/trials/v1/NCT07296445/registered