20 results
Primary Objective:To demonstrate pharmacokinetic biosimilarity of ONS-1045 (Oncobiologics) to the EU- and US licensed product of Avastin® following a single 2.0 mg/kg i.v. infusion, in healthy male adult subjects.Secondary objective:• To evaluate…
The objective of this trial is to evaluate the safety and efficacy of the combination of Fovista® intravitreous administration with Avastin® compared to Avastin® monotherapy.
PRIMARY OBJECTIVES Part I - To evaluate the efficacy (as measured by PFS) of GDC-0941 340 mg +carboplatin * paclitaxel (Arm A) versus carboplatin * paclitaxel (Arm B) in all patients with squamous NSCLC -To evaluate the efficacy (as measured by PFS…
Primary Objective: The primary objective for this study is to compare the efficacy of ABP 215 with bevacizumab.Secondary Objective(s): The secondary objectives are to assess the safety and immunogenicity of ABP 215 compared with bevacizumab.
To demonstrate that combined (repeated) laser photocoagulation prolongs time to failure compared to anti-VEGF monotherapy.
Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn*s Disease.
The primary objective of this study is to confirm the efficacy and safety of Genz 112638 after 39 weeks of treatment in patients with Gaucher disease type 1.The secondary objective of this study is to determine the long term efficacy, safety, and…
Objectives:The following objectives are designed to address the effects of SCH 530348 when administered orally in addition to the standard of care for a minimum of 1 year in subjects with documented atherosclerotic disease.Primary Objective: The…
Objectives:Primary Objective:* To compare the overall survival (OS) distributions of RP101 and gemcitabine to placebo and gemcitabine in subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinomaSecondary Objectives:* To…
Part A:To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeksPart B:• To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of RA at 24…
Efficacy Objectives:- Primary objective of this study is to demonstrate non inferior efficacy of PGL4001 versus GnRH-agonist to reduce, prior to surgery, excessive uterine bleeding caused by uterine myomas.- Secondary objectives are to demonstrate…
The objective of this study is to evaluate the safety and efficacy of A-002 when added to atorvastatin plus standard-of-care in subjects with an ACS. Specifically this study will examine the effect of treatment on morbidity and mortality as defined…
Primary Objective: The primary objective is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12. Secondary Objectives: Evaluate the efficacy…
The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Primary Objective* The primary objective of this study is to compare the confirmed objective response rate (ORR) by Week 19 following treatment with bevacizumab-Pfizer in combination with paclitaxel and carboplatin to bevacizumab-EU plus paclitaxel…
The primary objective of the study is to assess the efficacy and safety of 3 different treatment arms (bevacizumab alone, atezolizumab-bevacizumab combination with acetylsalicylic acid and atezolizumab-bevacizumab combination with placebo) in…
The primary objectives of the study are:• To evaluate the effect of 24 weeks treatment with CER-001 on carotid Mean Vessel Wall Area (MVWA) as compared to placebo using 3T magnetic resonance imaging (3T-MRI);• To evaluate the safety and tolerability…
The goal of the trial is to compare the efficacy and costs of bevacizumab 1.25 mg and ranibizumab 0.5mg given as monthly intravitreal injections over 6 months for the treatment of macular edema secondary to a retinal vein occlusion.
The goal of the trial is to compare the efficacy and costs of bevacizumab 1.25 mg and ranibizumab 0.5mg given as monthly intravitreal injections over 6 months for the treatment of diabetic macular edema.