Trial · NCT03048344
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To identify the recommended dose | From baseline to Week 4 | The recommended dose is determined by the number of patients who experience a dose limiting toxicity (DLT). |
| Primary | Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability of ORH-2014 when administered at the MTD or recommended dose | Up to Week 28 | To evaluate safety and tolerability the aggregate review will include but is not limited to: * NCI-CTCAE Grade 3 and 4 AEs, serious adverse events (SAEs), deaths; * Laboratory results; * Vital signs; * ECGs; * Individual subject profiles including, but not limited to: medical history, AEs, concomitant medications, laboratory results, and vital signs; * Subject disposition and screen failure rates. |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by maximum observed concentration (Cmax) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by time to maximum concentration (Tmax) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by apparent terminal elimination half-life (t1/2) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by area under the concentration-time curve from 0 to 24 hours (AUC0-24) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by area under the concentration-time curve extrapolated to infinity (AUC0-infinity) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by apparent terminal elimination rate constant (λZ) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by apparent total clearance (CL/F) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by apparent total clearance normalized by body weight (CL/F/kg) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by apparent total volume of distribution (Vz/F) | Baseline up to Week 24 | |
| Secondary | To determine the plasma pharmacokinetic (PK) profiles of total arsenic as measured by accumulation ratio (AR) | Baseline up to Week 24 | |
| Secondary | To evaluate the effect of ORH-2014 on QT-interval corrected for heart rate using Fridericia's formula (QTcF) | Baseline up to Week 28 | |
| Secondary | Safety Assessment during the expansion phase of the study on the effect of oral ORH-2014 on safety parameters | Baseline up to Week 28 | During the expansion phase of the study, an aggregate clinical data review (ACDR) will be conducted. This review will collect data from electronic data capture, the ECG central review vendor (ERT), and other sources to include but is not limited to: * NCI-CTCAE Grade 3 and 4 AEs, SAEs, deaths; * Laboratory results; * Vital signs; * ECG's; * Individual subject profiles including, but not limited to: medical history, AEs, concomitant medications, laboratory results, and vital signs; * Subject disposition and screen failure rates. |
| Secondary | The number of participants with a complete response (CR) or partial response (PR) according to International Working Group (IWG) response criteria | Up to Week 24 | Bone marrow aspirates and/or biopsies will be obtained at the designated timepoints for evaluation of efficacy. Response criteria will be according to the International Working Group. Responders are participants who obtain complete remission (CR) or partial remission (PR), with or without cytogenetic response, and marrow complete remission. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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
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