5 results
Primary:* To determine if alisertib improves overall response rate (ORR; complete response [CR] plus partial response [PR]) versus a selection of single agents in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)* To determine…
Co-primary (tested in parallel for non-inferiority):-To compare daprodustat to darbepoetin alfa for CV safety (non-inferiority)-To compare daprodustat to darbepoetin alfa for Hgb efficacy(non-inferiority)
Co-primary (tested in parallel for non-inferiority):- To compare daprodustat to rhEPO for CV safety (non-inferiority)- To compare daprodustat to rhEPO for Hgb efficacy(non-inferiority)
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…
Primary objectives: - Describe the safety of daprodustat, overall (all ages) and in each age group.Secondary objectives:- Describe changes in other parameters relevant to safety, overall and in each age group.- Describe the effect of daprodustat on…