8 results
The objectives of this follow-up/extension study of the VIPES study are:• To assess the efficacy of Viaskin® Peanut after up to 36 months of Epicutaneous Immunotherapy (EPIT) in peanut-allergic subjects.• To evaluate the safety of long-term…
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
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
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 objectiveTo assess the safety and tolerability of intravenous 131I-IPA administered concomitantly to 2nd line XRT in recurrent GBMSecondary objectives:- To assess the maximum tolerated dose (MTD) of 131I -IPA administered concomitantly to…
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 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…
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…