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NCT ID: NCT03141177 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

CheckMate 9ER
Start date: August 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

NCT ID: NCT03138941 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region

APLCLLDAS
Start date: September 1, 2013
Phase:
Study type: Observational [Patient Registry]

Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus Erythematosus (SLE). SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe manifestations of SLE are the accrual of irreversible organ damage, especially renal and central nervous system (CNS) involvement. As there is no effective targeted monotherapy for SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum immunosuppressive therapies. Despite combination therapy with current drugs, many studies show that the majority of patients suffer inadequate disease control and inexorably accrue permanent organ damage over time. The diversity of clinical features of active SLE has made quantification of disease activity problematic. Although there are a number of published systems in use to measure SLE disease activity, there are widely acknowledged problems with these instruments. Published definitions of remission are so stringent that they are met by less than 5% of patients. This lead to the realisation that rather than lupus remission, a lupus low disease activity state target may be more feasible, and that patients with low disease activity are more homogeneous than patients with active disease. Thus, the development of a definition of lupus low disease activity, which is feasible and has face validity, escapes the complexity of attempts to quantify heterogeneous states of active disease. In this study, the investigators will prospectively collect longitudinal data on consecutive SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage accrual as the primary endpoint.

NCT ID: NCT03138512 Completed - Clinical trials for Carcinoma, Renal Cell

A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney

CheckMate 914
Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

NCT ID: NCT03138499 Terminated - Hodgkin's Disease Clinical Trials

A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,

CheckMate 812
Start date: June 26, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant

NCT ID: NCT03138486 Not yet recruiting - Clinical trials for Various Advanced Cancer

A Study of the Effectiveness in Patients With Gastric or Gastroesophageal Junction Cancer With Nivolumab by Itself or in Combination With Ipilimumab and in Patients With Esophageal Cancer With Combination of Nivolumab and Ipilimumab.

CheckMate 648
Start date: June 1, 2017
Phase: Phase 2
Study type: Interventional

The main purpose of this study for patients with gastric or gastroesophageal cancer is to evaluate how well the tumor is responding to treatment with nivolumab by itself, or in combination with ipilimumab. For patients with esophageal cancer, the main purpose is to evaluate how well the tumor is responding to treatment with the combination of nivolumab and ipilimumab.

NCT ID: NCT03137784 Completed - Asthma Clinical Trials

Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma

Start date: May 4, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients

NCT ID: NCT03136380 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study of Danirixin in Japanese Healthy Elderly Male Subjects

Start date: May 10, 2017
Phase: Phase 1
Study type: Interventional

Danirixin is a selective chemokine receptor antagonist being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD). The aim of the study is to assess the safety, tolerability and pharmacokinetics (PK) in healthy Japanese subjects over the age of 65 years (inclusive). The study will be conducted in two parts: Part 1 will be a double blind, placebo-controlled, 3-period crossover, ascending single oral dose administration of GSK1325756H (Hydrobromide Salt Tablet Formulations of Danirixin) 10, 50 and 100 milligram (mg) in the fed condition. Part 2 will be an open label, 2-period crossover, single oral dose of GSK1325756H 50 mg in fed and fasted state. This study will provide an understanding of PK of hydrobromide salt of GSK1325756 in population of healthy elderly subjects and also contribute to the selection of appropriate dosing for Phase IIa study in Japan.

NCT ID: NCT03135028 Terminated - Clinical trials for Acute Myeloid Leukemia

Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults

Japanese AML
Start date: May 19, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of entospletinib (ENTO) monotherapy and in combination with chemotherapy in Japanese participants.

NCT ID: NCT03131648 Completed - Atopic Dermatitis Clinical Trials

Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)

ECZTRA 1
Start date: May 30, 2017
Phase: Phase 3
Study type: Interventional

Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.

NCT ID: NCT03131453 Terminated - Alzheimers Disease Clinical Trials

A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

GS2
Start date: August 3, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.