11 results
To demonstrate the efficacy of ponatinib administered at 2 starting doses (30 and 15 mg QD) compared to nilotinib administered at 400 mg BID in patients with CP-CML who are resistant to imatinib, as measured by MMR by 12 months
This phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib
The co-primary objectives of this study are to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on: • Intraoperative pupil diameter.• Pain during…
Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…
Primary objectives:Phase 1: To determine the MTD and/or RP2D of oral ponatinib administered QD in pediatric participants with selected advanced hematologic malignancies or solid tumors.Phase 2- Group A (CP-CML): To determine the efficacy of oral…
This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at <= 4 bpm root mean squared error (RMSE); interbeat intervals at <= 50 ms RMSE; breathing rate at <= 2 brpm RMSE; and…
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
Primary objective: To compare the number of episodes of atrial fibrillation detected by the Corsano CardioWatch 287-2 during 28 days of use with the number of episodes of atrial fibrillation detected by conventional Holter monitoring during 48 hours…
This study aims to evaluate the Corsano Cardiowatch 287-2 for heart rate, heart rate variability (RR intervals), oxygen saturation, respiratory rate, and blood pressure during strenuous activities such as High-Intensity Interval Training (HIIT).…
Primary Objectives:Phase 1 Primary Objective** To determine the RP2D of ponatinib (tablet and AAF) in combination with chemotherapy.Phase 2 Primary Objective* * To determine the efficacy of ponatinib in combination with chemotherapy as measured by…
To assess the ability to track blood pressure decrease measured by the Corsano CardioWatch 287-2 after a period of 28 days of antihypertensive drug treatment initiation, uptitration or change in antihypertensive drugs.