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NCT ID: NCT01938443 Completed - Cancer Clinical Trials

A Dose Escalation Study to Assess Safety of GSK2256098 (FAK Inhibitor) in Combination With Trametinib (MEK Inhibitor) in Subjects With Advanced Solid Tumors

Start date: November 18, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety of combination treatment of GSK2256098 and trametinib in mesothelioma subjects and subjects with other selected tumor types. Also, the study will identify a maximum tolerated combination dose of GSK2256098 and trametinib. This study is a Phase I, open-label, dose-escalation study to determine maximal tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and regimens for oral MEK inhibitor trametinib (once daily [OD]dosing) and the oral FAK inhibitor GSK2256098 (twice daily [BID] dosing). The synergy of the combination was observed over a wide range of concentrations and results in several-fold reduction in compound concentration to achieve equivalent biological responses compared to either single agent. The dose and schedule of dosing may be modified based on emerging safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. The study will be conducted in two parts; Part 1 Dose Escalation to determine the MTD and RP2D and Part 2 Expansion Cohort to further evaluate the safety and tolerability of trametinib and GSK2256098 at the RP2D and determine clinical activity. Additionally, in Part 1 Dose Escalation, additional subjects with malignant pleural mesothelioma (MPM) will be recruited at doses that are considered tolerable in order to assess PD in MPM subjects at each dose (the Pharmacodynamic Cohort). The Expansion Cohort will be limited to subjects with MPM who have progressed or are intolerant to first-line therapy.

NCT ID: NCT01938352 Completed - Influenza Clinical Trials

Evaluation of the Protective Efficacy and Safety of CR8020 in an Influenza Challenge

Start date: October 2, 2013
Phase: Phase 2
Study type: Interventional

After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.

NCT ID: NCT01938248 Completed - Stroke Clinical Trials

Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation

ARTESiA
Start date: May 2015
Phase: Phase 4
Study type: Interventional

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.

NCT ID: NCT01938001 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)

AUGMENT
Start date: November 21, 2013
Phase: Phase 3
Study type: Interventional

This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

NCT ID: NCT01937533 Completed - Cancer Clinical Trials

Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical Cancer

Start date: October 2, 2013
Phase:
Study type: Observational

This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI at 3T can be used to differentiate different histological characteristics within whole tumours and so determine if the technique could be of prognostic value. The study hypothesis is that this technique will be able to differentiate tumours with histological features known to be associated with poor prognosis (tumour type, grade and lymphovascular space invasion).

NCT ID: NCT01937442 Completed - Multiple Myeloma Clinical Trials

Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma

Start date: November 7, 2013
Phase: Phase 1
Study type: Interventional

Objective of this study is to characterize the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.

NCT ID: NCT01937338 Completed - Clinical trials for LPS Challenge, Neutrophils

Study to Investigate the Effect of a Single Dose of AZD7624 on Inflammation Caused by an Endotoxin Challenge

Start date: October 2013
Phase: Phase 1
Study type: Interventional

Study to investigate the effect of a single dose of AZD7624 on inflammation caused by an endotoxin challenge.

NCT ID: NCT01937026 Completed - Healthy Volunteers Clinical Trials

A Study of Baricitinib and Probenecid in Healthy Participants

Start date: September 2013
Phase: Phase 1
Study type: Interventional

The purposes of this study are to assess how the body handles baricitinib when it is given with another drug called probenecid. The study doctor will measure the amount of baricitinib that is absorbed into the blood stream and the time that it takes to remove baricitinib from the body. The safety and tolerability of these drugs will be studied. The study will last about 18 days from the first dose to the end of the study (not including screening.)

NCT ID: NCT01936779 Completed - NAFLD Clinical Trials

Understanding the Role of Dietary Fatty Acids on Liver Fat Metabolism in Humans

Start date: September 2013
Phase: N/A
Study type: Interventional

High levels of fatty substances in the blood increase the risk of developing heart disease. Investigators know a lot about one of these fatty substances, cholesterol. However, there is another fatty substance in the blood called triglyceride. Investigators do not understand much about what regulates the rate at which the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s). It is known that taking fish oil lowers the amount of blood triglyceride however, it remains unclear how this happens. Investigators will study if changes in liver fat metabolism, after taking fatty acids found in fish oil (n-3 fatty acids)can explain the lowering of blood triglyceride. Investigators also want to know if taking fish oil alters the amount of fat that accumulates within the liver.

NCT ID: NCT01935791 Completed - Metabolic Diseases Clinical Trials

Investigating Brown Adipose Tissue Activation in Humans

Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine what can activate brown adipose tissue (BAT).