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NCT ID: NCT02337608 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

ORIGIN
Start date: December 2014
Phase: Phase 2
Study type: Interventional

- Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 weeks in addition to their stable background treatment. - During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG1205 present in the blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will be determined.

NCT ID: NCT02336815 Completed - Multiple Myeloma Clinical Trials

Selinexor Treatment of Refractory Myeloma

STORM
Start date: May 26, 2015
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

NCT ID: NCT02336451 Completed - Clinical trials for ALK-positive Non-small Cell Lung Cancer

A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

Ascend-7
Start date: April 1, 2015
Phase: Phase 2
Study type: Interventional

This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

NCT ID: NCT02334709 Completed - Clinical trials for Carcinoma, Renal Cell

Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect.

Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Tyrosine kinase inhibitors (TKIs) are often used in the standard treatment for patients with metastasized renal cell carcinoma. In addition to their ability to specifically inhibit tumor growth, TKIs also interfere with the vascularisation of the tumor. Unfortunately, most patients do not obtain long-lasting clinical benefit from this treatment. The goal of the current study is to enhance the effect of TKIs by combining them with stereotactic radiotherapy treatment of one of the metastases. This type of radiotherapy allows us to precisely irradiate the tumor with minimal effect on the surrounding healthy tissue. Recently it has been demonstrated that this type of radiotherapy stimulates the immune system to attack the tumor. By combining stereotactic radiotherapy with TKIs we expect to observe a reduction of metastases in a bigger population of patients. In the first part of our study we focus on the safety of the combination therapy. In the second part we will evaluate the combined treatment response.

NCT ID: NCT02333331 Completed - Sarcopenia Clinical Trials

Dose Range Finding Study of Bimagrumab in Sarcopenia

Start date: December 9, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

NCT ID: NCT02329327 Completed - Bleeding Clinical Trials

A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)

Start date: April 10, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.

NCT ID: NCT02327572 Completed - Breast Cancer Clinical Trials

Age-related Changes in the Immune System and Their Impact on Elderly Breast Cancer

IMAGE
Start date: March 2014
Phase: N/A
Study type: Observational

This research project aims to study this intriguing relationship between ageing and breast cancer biology, and more specifically the changes that occur within the tumor microenvironment with increasing age. Furthermore, it will focus on the link between these microenvironmental changes and organismal ageing (as measured by chronological age, geriatric evaluation of elderly patients, and circulating biomarkers of ageing), since it seems logical that age-related changes in the stromal part of a tumor (fibroblasts, immune cells, endothelial cells, fatty cells, …i.e. host cells) are due to the ageing process of the entire body. Most particularly, the amount and type of infiltrating immune cells might reflect the degree of immunosenescence of the host. More and more research points out the crucial role of the immune system in tumorigenesis and progression, and, at the same time, the immune system is one of the most affected components in the process of ageing. .

NCT ID: NCT02326233 Completed - Healthy Clinical Trials

Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

Start date: June 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.

NCT ID: NCT02325037 Completed - Healthy Clinical Trials

First-in-Human Single and Multiple Dose of GLPG1837

Start date: December 2014
Phase: Phase 1
Study type: Interventional

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized. The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated. The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.

NCT ID: NCT02324946 Completed - Clinical trials for Bariatric Surgery Candidate

Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation.

Start date: October 2014
Phase: N/A
Study type: Observational

The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea. This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation.