6 results
To provide UT-15C for eligible subjects who participated in study protocol TDE-PH-310
The principal objective of the study is to determine if the performance of the new technique (magnetic tracer and magnetometer) is equivalent to the performance of the standard technique (patent blue dye and radioistope; or radioisotope alone). The…
The principal objective of the study is to determine if the performance of the new technique (magnetic tracer and magnetometer) is equivalent to the performance of the standard technique (patent blue dye and radioisotope, wire localization).The…
The principal objective of the study is to determine if the performance of the new technique (magnetic tracer and magnetometer) is equivalent to the performance of the standard technique (patent blue dye and radioisotope; or radioisotope alone).The…
To assess the effect of oral UT-15C with PAH-approved oral monotherapy compared to placebo with PAHapproved oral monotherapy on time to first clinical worsening event (adjudicated), as defined by at least one of the events listed below:- Death (all…
Primary Objective:Part 1:- To determine the MTD and recommended phase 2 dose (RP2D) of avapritinib.- To determine the safety and tolerability of avapritinib.Part 2:* To determine the overall response rate (ORR) by RECIST criteria at the MTD/RP2D of…