Advertisement

Topics

A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies

2014-08-27 04:00:36 | BioPortfolio

Summary

This is an open-label, randomized, single-dose, 2-treatment, 2-period, 2-way crossover study with incomplete wash-out in subjects with solid tumors to determine the relative bioavailability of test formulation with lower dimethyl sulfoxide (DMSO) content as compared with standard reference formulation trametinib.

Approximately 18 subjects will be randomized to receive either a single dose of Treatment A (standard target DMSO content [theoretical 11.3%] formulation of GSK1120212B) or a single dose of Treatment B (lower DMSO Content [approximately 9.5%] formulation of GSK1120212B) followed by a 7 day incomplete wash-out period, then a single dose of the other treatment.

Administration of the dose under fasted conditions in Periods 1 and 2 will be only on Day 1 followed by 7 days of serial blood sampling for PK analysis of plasma trametinib. Safety assessments, including assessment of AEs, clinical laboratory (hematology and clinical chemistry) and vital signs, will be made throughout the study.

After a subject completes the study, he or she may be eligible to enter study MEK114375, an open-label rollover study of trametinib (no wash-out period or follow-up visit required) and continue receiving trametinib. For those subjects who wish to discontinue or complete the current study and choose not enter the rollover study, a follow-up visit should be performed within 21 days after receiving the last dose of study treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Cancer

Intervention

GSK1120212B (Standard DMSO content), GSK1120212B (Lower DMSO content)

Location

GSK Investigational Site
Goodyear
Arizona
United States
85338

Status

Recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:36-0400

Clinical Trials [905 Associated Clinical Trials listed on BioPortfolio]

Comparison of the Treatment of Refractory Bladder Pain Syndrome With DMSO and DMSO With Botulinum Toxin A

The purpose of this research study is to evaluate the efficacy of intravesical botulinum A toxin and DMSO in women with bladder pain syndrome who have not responded to first-line treatment...

DMSO Efficacy in IC/PBS Patients During and After Treatment

The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6 ...

DMSO-PDT of BCC - A 6 Year Follow Up

The purpose of this study is to registrate long time clinical and histological treatment response of BCC lesions treated with one or two procedures of DMSO-PDT.

Botulin-A Toxin Instillations and Overactive Bladder

The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of trea...

Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis

The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers fr...

PubMed Articles [13943 Associated PubMed Articles listed on BioPortfolio]

DMSO: A Mixed-Competitive Inhibitor of Human Acetylcholinesterase.

Dimethyl sulfoxide (DMSO) is the most common organic solvent used in biochemical and cellular assays during drug discovery programs. In spite of its wide use, the effect of DMSO on several enzyme clas...

Solvation Properties of the Actinide Ion Th(IV) in DMSO and DMSO:Water Mixtures through Polarizable Molecular Dynamics.

We have studied the solvation of Th(4+) in water, in dimethyl sulfoxide (DMSO), and in their equimolar mixture by using molecular dynamics based on an Amoeba-derived polarizable force field. We have p...

Magneto-structural correlation of hexakis-dmso cobalt(ii) complex.

The magnetostructural correlation of the hexakis-dmso cobalt(ii) complex, [Co(dmso)6](BPh4)2 (dmso: dimethylsulfoxide), was investigated by single-crystal X-ray diffraction study and magnetic measurem...

A high concentration of DMSO activates caspase-1 by increasing the cell membrane permeability of potassium.

Dimethyl sulfoxide (DMSO) is widely used in the laboratory and in clinical situations because it is soluble in both aqueous and organic media and can be used to treat many types of diseases. Thus, it ...

Vitrification of testicular tissue from prepubertal cats in cryotubes using different cryoprotectant associations.

Protocols for the cryopreservation of testicular tissue are not yet established. In cats, few studies have been conducted on testicular vitrification using different cryoprotectant associations (CPAs)...

Medical and Biotech [MESH] Definitions

An interdisciplinary study dealing with the transmission of messages or signals, or the communication of information. Information theory does not directly deal with meaning or content, but with physical representations that have meaning or content. It overlaps considerably with communication theory and CYBERNETICS.

The urea concentration of the blood stated in terms of nitrogen content. Serum (plasma) urea nitrogen is approximately 12% higher than blood urea nitrogen concentration because of the greater protein content of red blood cells. Increases in blood or serum urea nitrogen are referred to as azotemia and may have prerenal, renal, or postrenal causes. (From Saunders Dictionary & Encyclopedia of Laboratory Medicine and Technology, 1984)

A type of impedance plethysmography in which bioelectrical impedance is measured between electrodes positioned around the neck and around the lower thorax. It is used principally to calculate stroke volume and cardiac volume, but it is also related to myocardial contractility, thoracic fluid content, and circulation to the extremities.

Glycoproteins which have a very high polysaccharide content.

A preparation of hog pancreatic enzymes standardized for lipase content.

More From BioPortfolio on "A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Diagnostics
A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example: to diagnose diseases to measure the progress or recovery from disease to confirm that a person is free from disease Clin...


Searches Linking to this Trial