117 results
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…
Primary objective:* To demonstrate that subjects who receive an 8-day series of Otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion at 12 months after study drug administration. Secondary…
The objective is to investigate the efficacy and safety of afatinib over placebo when given as adjuvant therapy for patients with no evidence of disease after CRT in primary unresected patients with LA SCC stage III or IVa/b of the oral cavity,…
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…
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…
The primary objective of this study is:To evaluate the efficacy of a regimen containing elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS 9350 versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV 1…
Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients withMild Cognitive Impairment Due to Alzheimer*s Disease or Mild Alzheimer's Disease
Primary Objective To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo adjuvanted with imiquimod, to induce HPV 16 and 18 viral clearance at 12 months in HPV 16 and/or 18 infected women using a type specific,…
Primary objectiveThe primary objective of the study is to estimate the effects of tofacitinib in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn*s disease previously achieving clinical response or…
The primary objective of this study is:To confirm the effect of Tasquinimod on delaying disease progression or death compared with placebo.The secondary objectives of this study are:• To determine the effect of Tasquinimod on overall survival, time…
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.
The study is designed to evaluate the efficacy and safety of fingolimod in the treatment of CIDP compared with placebo. Data from this study will be used to support the registration of fingolimod in the indication of CIDP.
Primary Objective:- To evaluate the efficacy of PF-04360365 (ponezumab) in subjects with probableCAA as compared to placebo on a BOLD fMRI measure of cerebrovascularreactivity.Secondary Objectives:- To evaluate the efficacy of PF-04360365 (ponezumab…
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…
This study is set-up to evaluate the safety and tolerability of CCX168 in subjects with mild to moderate AARV on a background of cyclophosphamide treatment. It will assess the possibility to optimize the treatment with CCX168 and to reduce the side…
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 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…
To assess the long-term safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension (PAH).
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 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)