5 results
Stratum 1:To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu) results in a non inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte…
Primary Objective• To assess superiority of treatment with CAM2029 compared to treatment with octreotide long-acting release (LAR) or lanreotide autogel (ATG) on progression-free survival (PFS) in patients with unresectable/metastatic and well-…
CORE PERIODPrimary:* Evaluate the safety and tolerability of up to 24 weeks of AG-348 administration in patients with pyruvate kinase deficiency (PK deficiency).Secondary:* Evaluate the pharmacokinetics (PK) of AG-348 and the metabolite AGI-8702.*…
Primary:*To identify the maximum tolerated dose (MTD) and to investigate the pharmacokinetics (PK) of a single dose of lanreotide PRF in subjects with acromegalySecondary:*To investigate the safety and tolerability of a single dose of lanreotide PRF…
Primary Objective* To describe the antitumour efficacy of LAN monotherapy plus BSC every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria,…