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NCT ID: NCT01340846 Completed - Cancer Clinical Trials

A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors

Start date: September 3, 2012
Phase: Phase 1
Study type: Interventional

GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study (in 4 separate cohorts of subjects) designed to examine the interaction potential of GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C: gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters of GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain approximately 12 evaluable subjects each for Part A, Part B, Part C and Part D. Following completion of this study, subjects may continue dosing with GSK2118436 in the roll-over study, Protocol BRF114144.

NCT ID: NCT01339884 Completed - Friedreich Ataxia Clinical Trials

A Study of Resveratrol as Treatment for Friedreich Ataxia

Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of two doses of resveratrol taken for a 12 week period, on frataxin levels in individuals with Friedreich ataxia. This study will also measure the effect of resveratrol on markers of oxidative stress, clinical measures of ataxia, and cardiac parameters.

NCT ID: NCT01339598 Completed - Bipolar Disorder Clinical Trials

Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)

Start date: September 2011
Phase: Phase 1
Study type: Interventional

This study aims to investigate the potential for Transcranial Direct Current Stimulation (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tDCS (placebo control) during the performance of two cognitive tasks. The investigators hypothesize that task performance will be improved with active relative to sham tDCS.

NCT ID: NCT01339585 Completed - Effects on Learning Clinical Trials

The Effect of Timing of Transcranial Direct Current Stimulation (tDCS) for Enhancing Learning During Cognitive Training

Start date: May 2011
Phase: N/A
Study type: Interventional

This project will investigate a novel strategy for enhancing cognitive training (CT). Specifically, the investigators aim to combine a non-invasive form of brain stimulation (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be administered either before or during CT.

NCT ID: NCT01338415 Completed - Clinical trials for Pulmonary Arterial Hypertension

FUTURE 3 Study Extension

FUTURE 3 Ext
Start date: March 8, 2011
Phase: Phase 3
Study type: Interventional

The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

NCT ID: NCT01337765 Completed - Solid Tumor Clinical Trials

Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

Start date: July 8, 2011
Phase: Phase 1
Study type: Interventional

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162. Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.

NCT ID: NCT01337401 Active, not recruiting - Clinical trials for Alveolar Soft-part Sarcoma

A Trial of Cediranib in the Treatment of Patients With Alveolar Soft Part Sarcoma (CASPS)

CASPS
Start date: July 2011
Phase: Phase 2
Study type: Interventional

The study is a two-arm, randomised, double-blind, international, multi-centre phase II trial of cediranib in Alveolar Soft Part Sarcoma (ASPS). The study aims to confirm the ability of cediranib to halt disease progression in patients with metastatic ASPS, as measured by the change in tumour size at 24 weeks after randomisation, and to produce objective response according to RECIST criteria.

NCT ID: NCT01337089 Completed - Pain Clinical Trials

Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

Start date: January 19, 2011
Phase: Phase 3
Study type: Interventional

This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.

NCT ID: NCT01336465 Completed - Ulcerative Colitis Clinical Trials

Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Start date: September 2011
Phase: Phase 2
Study type: Interventional

This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.

NCT ID: NCT01336023 Completed - Clinical trials for Diabetes Mellitus, Type 2

Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes

DUALâ„¢ I
Start date: May 23, 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.