4 results
- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…
- To assess the safety and (local) tolerability of test compound following single rising dose administration by subcutaneous injection- To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of test compound following single rising…
* Confirm device safety and performance* Confirm implant procedure and therapy adjustment procedure safety and performance
Primary:• The primary objective of the study is to demonstrate the efficacy of vorasidenib based on radiographic progression-free survival (PFS) per blinded independent review committee (BIRC) compared with placebo in subjects with residual or…