116 results
To evaluate the efficacy of ACZ885 plus MTX by assessing the response to treatment (ACR50) as compared to MTX alone in early RA patients after 6, 14 and 26 weeks of treatment. The study aims to evaluate the clinical response in this RA subpopulation…
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…
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…
The primary objective of the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…
The primary objective of this confirmatory study is to confirm the acid neutralisation action of Gaviscon Double Action Liquid versus placebo liquid, within the stomach.
The purpose of this studie is to evaluate the bioequivalence of canagliflozin.
The primary objectives of this study are:1. To evaluate the safety and tolerability of PTG-1002. To evaluate the efficacy of PTG-100 in the induction treatment of subjects with moderate to severe active UC compared to placebo.The secondary…
The primary objective of this study is to assess the noninferiority of ALXN1210 compared to eculizumab in adult patients with PNH who have never been treated with a complement inhibitor. Noninferiority will be claimed if after 26 weeks of treatment…
Primary objectiveTo determine whether the clinical response after 10-day oral administration of cadazolid is non-inferior to oral vancomycin in subjects with CDAD.Secondary objectivesTo determine whether oral administration of cadazolid for 10 days…
Primary ObjectivePhase Ia* To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)and assess the safety of single agent GDC-0810 in postmenopausal women with locally advanced or metastatic estrogen-receptor-positive (ER…
The primary objective of the study is Study to determine the Safety, Tolerability, Pharmacokinetics and Effect on Circulating Alpha-1 Antitrypsin Levels of ARC-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD)
The primary objectives of the study are:For Parts A through C:1. Evaluate the safety and tolerability of multiple doses of CX-072, administered as monotherapy or in combination with ipilimumab or vemurafenib to patients with metastatic or locally…
To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide prolongs overall survival (OS) in subjects with newly diagnosed GBM harboring EGFR amplification.
The objective of this study is to evaluate the effect of cabozantinib compared with placebo on overall survival in subjects with advanced HCC previously treated with sorafenib.
Safety objective: To evaluate the safety and tolerability of UTTR1147AExploratory Efficacy Objective: To evaluate the efficacy of UTTR1147AExploratory Pharmacokinetic Objective: To evaluate potential relationships between long-term drug exposure and…
The primary objective is to evaluate the efficacy of V565 555 mg TID in subjects with active CD measured by the proportion of subjects achieving response to therapy. Response is defined as reduction in the Crohn's Disease Activity Index (CDAI)…
Primary: Evaluate the efficacy of patient-derived tumor organoids to successfully allocate patients for treatment with specific targeted agents.Secondary: Characterize safety and tolerability per experimental treatment regimen.
The primary objectives of this study are:* To evaluate tracer kinetic models for the purpose of quantifying specific binding of 18F-AV-1451 in cross sectional and longitudinal applications; and* To evaluate simplified methods for quantification of…
Safety ObjectiveThe safety objective for this study is as follows:* To evaluate the safety and tolerability of atezolizumab in pediatric and young adult patients, focusing on the nature, frequency, and severity of serious and non-serious adverse…
Primary Objective*To assess the safety and tolerability of Patidegib Topical Gel, 2% inpatients who have completed PellePharm Study Pelle-926-201 or Pelle-926-301Secondary Objectives*To assess the efficacy of Patidegib Topical Gel, 2% in patients…