23 results
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The primary objective of the study is to determine the MTD (Maximally Tolerated Dose) of SGN-40 from among three possible dose levels when combined with a standard dose of bortezomib and to determine the safety and adverse event profile for…
To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.
Our primary objective is:i. To assess the quantity and regional distribution of [18F]DPA-714 binding as a marker of microglial activation in patients with FTD compared to controls. Our secondary objectives are: i. To compare the quantity and…
We will develop a bi-daily low-dose metronomic treatment schedule with paclitaxel in a convenient oral formulation and test whether this therapy has significant anti-angiogenic and anti-tumor activity.
The primary objective is to determine whether the rate of severe toxicity (CTC grade 3 to 5) associated with fluoropyrimidine treatment can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront genotypic…
Improve allo-SCT transplant outcome using a uniform conditioning regimen and pacritinib pretreatment by means of the proportion of patients with a failure within 6 months post-transplant. Events that are considered a failure are: primary graft…
The objective of the study is to compare conventional therapy with biological therapy in patients with early rheumatoid arthritis.
Core Primary Objectives:1. To investigate the safety and tolerability of EP0042 given alone or in combination with anti-cancer treatments.Module 1 Primary Objectives:1. To investigate the safety and tolerability of EP0042 given as a monotherapy in…
- Primary Objective:To evaluate the safety and tolerability of investigational regimens of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors- Secondary Objectives:To characterize PK of product(s) used in investigational…
In this study, we want to learn more about the effect and safety of Ceralasertib plus Durvalumab on the inhibition of tumour growth, and also to better understand NSCLC and associated health problems.We compare the effect and safety of Ceralasertib…
Primary: - To assess the effect of TAK-861 on excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).Please refer to the Study protocol for detailed description on the secondary Objective of…
To compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).
Primary objective:• Determine if ribociclib plus letrozole gives a >=100% improvement in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) as compared to chemotherapy in the surgical specimen*.Secondary objective• Study the…
The aim of this study is to investigate the efficacy and tolerability of pyridostigmine monotherapy and amifampridine as add-on compared to placebo in patients with MG.
PHASE 1 OBJECTIVES:Primary:To determine the safety of oral larotrectinib , including dose-limiting toxicity (DLT), in pediatric patients with advanced solid or primary central nervous system (CNS) tumors. PHASE 2 OBJECTIVES:Primary Objective:To…
Primary Objective:To evaluate the efficacy of adagrasib monotherapy and in combination with pembrolizumab administered in the first-line treatment setting to patients having NSCLC with KRAS G12C mutation.Secondary Objectives:• To characterize the…
Principal objectives: •To determine the safety, tolerability and recommended dose of FP- 1305 in subjects withadvanced solid tumours of the selected tumourtypes without standard treatment options.• To determine the safety, tolerability and early…
Primary:• To show the superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) with regard to prevention of disease progression assessed by liver histology and by partial…
-Primary objective- To separately study the efficacy, defined as MRD negative bone marrow and no progression according to the IWCLL criteria, of the two arms of the study of either venetoclax maintenance or MRD-guided venetoclax maintenance after…