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NCT ID: NCT01007968 Completed - Clinical trials for Advanced Solid Tumors

Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function

Start date: March 2010
Phase: Phase 1
Study type: Interventional

Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological malignancies. To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase I/II clinical studies. Panobinostat PK does not appear to be different in patients with solid tumors and hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is yet to be elucidated. Kidney and liver are involved in the elimination and metabolism of panobinostat. The current study is designed to evaluate the impact of hepatic function status on panobinostat PK.

NCT ID: NCT01007877 Completed - Driver Sleepiness Clinical Trials

Energy Drinks & Driving Ability

Start date: September 2009
Phase: N/A
Study type: Interventional

Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink counteracts driver sleepiness. Objective: The objective of this study is to compare driving simulator performance after (1) a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3) continued driving. Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy human volunteers, 21-35 years old. Intervention: Each subject performs 3 test days: 1. 4 hours continued driving 2. 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving 3. 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of the car.

NCT ID: NCT01006980 Completed - Malignant Melanoma Clinical Trials

A Study of RO5185426 in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)

Start date: January 2010
Phase: Phase 3
Study type: Interventional

This randomized, open-label study will evaluate the efficacy, safety and tolerability of RO5185426 as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients will be randomized to receive either RO5185426 [RG7204; PLEXXIKON: PLX4032] 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Patients in the dacarbazine arm may cross over to RO5185426 treatment.

NCT ID: NCT01006265 Completed - Multiple Sclerosis Clinical Trials

Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

Start date: October 1, 2009
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

NCT ID: NCT01005901 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

GLOW 1
Start date: October 2009
Phase: Phase 3
Study type: Interventional

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

NCT ID: NCT01005823 Completed - Atopic Dermatitis Clinical Trials

A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

Start date: October 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.

NCT ID: NCT01004588 Completed - Clinical trials for Muscle Loss in Elderly

The Effects of Resistance Training and Protein Supplementation in Healthy Elderly Men and Women.

Start date: November 2009
Phase: N/A
Study type: Interventional

The main objective of this study is to examine the effects of resistance type exercise training combined with nutritional support on body composition and muscle characteristics in healthy elderly men and women. For a comprehensive insight into the potential underlying mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad range of tests will be performed before, during, and after the intervention period.

NCT ID: NCT01004224 Completed - Clinical trials for Advanced Solid Tumors With FGFR1 Amplication

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Start date: December 11, 2009
Phase: Phase 1
Study type: Interventional

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

NCT ID: NCT01004003 Completed - Clinical trials for Carcinoma, Hepatocellular

Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Start date: October 22, 2009
Phase: Phase 2
Study type: Interventional

The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients

NCT ID: NCT01003093 Completed - Tuberculosis Clinical Trials

A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

THYB-01
Start date: November 2005
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB