A Phase I/IIa, First Time in human, open-label dose-escalation study of GSK2636771 in subjects with advanced solid tumors with PTEN deficiency

Conditions

Brain and Nervous System | Breast - Female | Breast - Male | Breast Cancer (ER, PR, and HER2 negative) | Colon | Colorectal Cancer | Endometrial Cancer | Gastric Adenocarcinoma | Glioblastoma Multiforme | Head/ Neck Squamous Cell Carcinoma | Lip, Oral Cavity and Pharynx | Lung | Melanoma | Melanoma, skin | Non-Small Cell Lung Cancer (NSCLC) | Other Female Genital | Ovarian Cancer | Ovary | Prostate | Prostate Cancer | Rectum | Stomach

What is the purpose of this trial?

To be eligible for the main study, your tumor tissue must have a greatly reduced amount of the PTEN protein (that is, it must score negative for this protein by a test). The reduced level of this protein is thought to indicate who may benefit most from taking this drug. The results of the PTEN test of your tumor tissue must be available before you may be screened for the main part of the study. Until the results of the testing are available, screening for the main study will not begin. In Part 1, this study will look at how people react to, and how the body uses GSK2636771 at different amounts and at different times. The effects of the drug, both good and bad, will be studied. Information about how the study drug you get affects your body and your health will be collected through a number of tests and procedures. GSK2636771 has never been given to people before. It has only been tested in animals and in the laboratory. It is investigational because it is not approved by the FDA for doctors to prescribe to patients.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
GlaxoSmithKline, LLC
Dates:
02/16/2012
Last Updated:
Study HIC#:
1111009273