Clinical Trials Logo

Filter by:
NCT ID: NCT02723955 Completed - Neoplasms Clinical Trials

Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

Start date: June 23, 2016
Phase: Phase 1
Study type: Interventional

GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

NCT ID: NCT02722902 Terminated - Glucose Intolerance Clinical Trials

Carnitine Infusion and Insulin Resistance

Start date: May 2016
Phase: N/A
Study type: Interventional

Insulin resistant subjects and type 2 diabetic patients are characterized by a decreased metabolic flexibility: a reduced capability to switch from fat oxidation in the basal state to carbohydrate oxidation in the insulin-stimulated state. This metabolic inflexibility is an early hallmark in the development of diabetes. Recent evidence suggests that a low carnitine availability may limit acetylcarnitine formation, thereby reducing metabolic flexibility. Thus, when substrate flux in the muscle is high, acetyl-CoA concentrations increase, leading to inhibition of pyruvate dehydrogenase (PDH) and thereby reducing glucose oxidation. The conversion of acetyl-CoA to acetylcarnitine relieves this acetyl-CoA pressure on PDH. To provide more direct insight into the effect of carnitine in preventing metabolic inflexibility and insulin resistance and to further explore the mechanism of action is the focus of this research. Here, we hypothesize that the capacity to form acetylcarnitine may rescue lipid-induced insulin resistance. To this end, insulin resistance will be induced by lipid infusion in healthy volunteers and it will be tested whether carnitine co-infusion can alleviate insulin resistance.

NCT ID: NCT02722889 Completed - Thoracic Aorta Clinical Trials

Aortic Elongation and Dissection

Start date: March 2016
Phase: N/A
Study type: Observational

Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta.

NCT ID: NCT02722603 Terminated - Chronic Pain Clinical Trials

Study to Compare Gabapentin to Tramadol in Children With Chronic Neuropathic or Mixed Pain

GABA-1
Start date: September 12, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy and safety of gabapentin relative to tramadol for the treatment of chronic, neuropathic or mixed pain in the paediatric population. Children from 3 months to less than 18 years of age experiencing moderate to severe chronic pain will receive either gabapentin or tramadol for 15 weeks. The difference in average pain scores between treatment arms at the end of the treatment period will be assessed.

NCT ID: NCT02722551 Withdrawn - Clinical trials for Mitral Valve Regurgitation

CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

RELIEF
Start date: November 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve

NCT ID: NCT02722538 Completed - Clinical trials for Urinary Bladder Cancer

Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer

Start date: May 31, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC).

NCT ID: NCT02722161 Completed - Healthy Clinical Trials

Olmutinib (BI 1482694) ADME Study

Start date: April 2016
Phase: Phase 1
Study type: Interventional

To investigate the basic pharmacokinetics of BI 1482694, its metabolites M1 and M2, and [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of [14C]BI 1482694 given to healthy male volunteers

NCT ID: NCT02720757 Terminated - Clinical trials for Pulmonary Disease, Chronic Obstructive

Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

Start date: August 26, 2016
Phase:
Study type: Observational

The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks. A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2.

NCT ID: NCT02720367 Completed - Clinical trials for Urinary Bladder Cancer

Safety and Tolerability of TAR-200 mg in Subjects With Non-Muscle-Invasive Bladder Cancer

Start date: January 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if TAR-200, an investigational drug-delivery system is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors (TURBT)

NCT ID: NCT02720120 Terminated - Clinical trials for Rheumatoid Arthritis

A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

This study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab [400, 1000, 1500, and 2000 milligrams (mg)]. In Part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in Part 1.