20 results
Primary ObjectivePart A: To characterize the effect of 12 weeks of subcutaneous (SC) AMG 145 on percentchange from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with homozygousfamilial hypercholesterolemiaPart B: To evaluate…
Primary Objective: To characterize the safety and tolerability of long-term administration ofAMG 145 among subjects with severe familial hypercholesterolemia
Primary: Longterm safety and tolerability of AMG 145.Secondary: Longterm efficacy of AMG 145.
Primary objectives-Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years.-Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an out…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives: Safety…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives:…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with heterozygous familial hypercholesterolemia.Secondary…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with heterozygous…
This study aims to demonstrate the effectiveness of dabrafenib with trametinib in pediatric patients with BRAF V600 mutant relapsed refractory HGG.This study aims to demonstrate the effectiveness of dabrafenib with trametinib compared to…
The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…
This study aims to investigate whether the administration of VCR in children with acute lymphoblastic leukemia, nephroblastoma, low-grade glioma, Hodgkin lymphoma and rhabdomyosarcoma by one-hour infusions, resulting in lower peak plasma…
The aim of this study is to reduce the indication for RT without compromising cure rates. To investigate if intensified consolidation therapy (DECOPDAC-21) compared to standard consolidation therapy (COPDAC-28) can compensate for reduction in RT.
Primary objective:- To confirm in a multicenter setting an improvement in EFS to 95% at 2 years of DA-EPOCH-R in patients with newly diagnosed high risk Burkitt lymphoma as compared to an expected EFS of 72% at 2 years for the control arm R-CODOX-M/…
Main objective:To evaluate change over time in executive function, as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory (SWM) strategy index of executive function, in subjects receiving statin…
PRIMARY OBJECTIVES*Phase 1 Dose Finding Studies:-To determine the recommended phase II dose (RP2D) of new systemic therapy regimens. *Frontline chemotherapy questions:-To compare systemic therapy regimens for patients with VHR disease at diagnosis (…
The primary objective is to compare the objective response rate (ORR) per Response Assessment in Neuro Oncology (RANO) criteria assessed by independent review committee (IRC) of DAY101 monotherapy versus standard of care (SoC) chemotherapy in…
Primary objectives Part A:To test the non-inferiority, as evaluated by OS, of three courses of HDCT compared to focal RT plus conventional chemotherapy as consolidation therapy following conventional chemotherapy in children with ATRT aged 12 - 35…
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong progression-free survival (PFS) compared with 6 cycles of standard R-…
The hypothesis is that personalised and risk-adapted treatment will improve outcome and reduce toxicity in post-pubertal patients with medulloblastoma.A further hypothesis is that clinical, magnetic resonance imaging (MRI) and voxel-based…
The Primary Objectives of the Phase 1b are: • To assess the safety and tolerability of carfilzomib, alone and in combination with induction chemotherapy, for the treatment of children with relapsed or refractory ALL • To determine the maximum…