58 results
Primary: To evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.Secondary: To describe long-term MS outcomes in subjects originally treated in Study 105MS301 who…
PrimaryTo compare progression-free survival (PFS) between tivozanib in combination with mFOLFOX6 and bevacizumab in combination withmFOLFOX6 based on investigator radiological tumor assessmentSecondary• Progression Free Survival (PFS) based on…
Primary objective:To evaluate efficacy of RO5185426 as a monotherapy compared to dacarbazine in terms of progression-free survival (PFS) and overall survival (OS) in previously untreated patients with advanced melanoma harbouring the BRAF V600E…
Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumor who could be treated with specific anti-hypoxic treatments. The added value of additional anti-hypoxic treatments depends on the…
The objective of this study is to evaluate the effect of cabozantinib compared with everolimus on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine…
Primary Objective• To evaluate best overall response rate (BORR; CR + PR) in Cohort 1 (TKI-naïve patients).* BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic resonance imaging, using RECIST…
The aim of this study is to (i) determine if tumor hypoxia can be accurately visualized with [18F] HX4 PET imaging in Cervix tumors (ii) correlate the [18F] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal…
Objectives:Primary:• To determine the absolute bioavailability of niraparib by using an intravenous (IV) niraparibmicrodose of 100 µg (containing approximately 1 µCi of [14C]-niraparib) in subjects with cancer.Secondary:• To characterize the…
To assess the long-term safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension (PAH).
The primary objective is:Assess the efficacy defined as Composite Complete Response (CRc)The secondary objectives of this study are:* Assess safety and tolerability* Assess immunogenicity and pharmacokinetics* Progression-free survival (PFS),…
The evaluation of the safety and pharmacokinetics of ABT-414 in combination with radiation plus temozolomide or temozolomide alone for subjects with Glioblastoma Multiforme.
The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator*s choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have relapsed…
Primary:1. To assess the pharmacokinetic profiles following single dose administration of MK-8408 administered as a PMF1 tablet by means of AUC0-*, AUClast, AUC0-24, Cmax, C24, tmax, and t* under fed conditions, following a high fat meal. 2. To…
The objective of this exploratory study is to investigate the acid neutralisation action of sodium alginate oral suspension versus placebo liquid, within the stomach and to assess suitability and robustness of the pH monitoring methodology.
- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…
The primary objectives of this study are the following:• To evaluate the safety and tolerability of DMOT4039A when administered every 3 weeks or weekly to patients with unresectable pancreatic or platinum-resistant ovarian cancer• To determine the…
PrimaryCompare the efficacy (measured by objective response rate [ORR] and overall survival [OS]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.SecondaryAssess other measures of clinical benefit, safety,…
Efficacy of ALXN1210Sub-study: to Evaluate Patient Preference for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy.Timepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To evaluate the activity of FL-101…