A New Regimen of an Experimental Drug and Enzalutamide to Treat Your Prostate Cancer (GSK 200331)
Technical Title: A Phase I, Open-Label, Dose-Finding Study of GSK2636771 Administered in Combination with Enzalutamide (Xtandi) in Male Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Disease Type: Metastatic, castration-resistant prostate cancer
This study will test the combination of a study drug, GSK2636771, and an approved drug, enzalutamide (Xtandi®), in men with metastatic castration-resistant prostate cancer (also called mCRPC). This type of prostate cancer is resistant to medical treatment or surgery that lowers testosterone levels and has spread (metastasized) to other parts of the body.
The purpose of this study is:
To take part in this study, you must have your tumor tissue tested for a protein called PTEN. You will only be offered the study treatment if your tumor tissue shows an absence of PTEN protein.
If you take part in this study, you will be taking one daily dose of GSK2636771 along with one daily dose of enzalutamide. GSK2636771 and enzalutamide are both in the form of capsules taken by mouth.
Research Procedures (not a complete list):
This is a two-part study. You will be asked to take part in only one part of the study. Part 1 is called the Dose Escalation Phase and Part 2 is called the Dose Expansion Phase.
In Part 1 (the Dose Escalation Phase), the first patients enrolled in the study will be given the starting dose of GSK2636771 and the FDA-approved dose of enzalutamide every day. The effects of GSK2636771 and enzalutamide, both good and bad, will be reviewed after each dose is taken. Additional men may be enrolled and they may take a higher or a lower dose of GSK2636771, but the dose of enzalutamide will stay the same. The dose of GSK2636771 will be increased or decreased until the highest and best dose of GSK2636771 for use in combination with enzalutamide is identified. Once that dose is determined, no more men will be enrolled and Part 1 of the study will be closed.
In Part 2 (the Dose Expansion Phase), patients will be treated with the appropriate doses of GSK2636771 determined in Part 1 and the FDA-approved dose of enzalutamide every day. Part 2 of this study will help see if the dose of GSK2636771 and enzalutamide has an effect on mCRPC and to look at long-term good and bad effects from taking both drugs together. More than one dose of GSK2636771 may be tested in Part 2.
Once you begin treatment with the study drug, you will need to come to the clinic once a week for the first 5 weeks, once during Week 8, and every 4 weeks thereafter. During the first week, you will need to get blood tests done on Day 3 or Day 4. These blood tests can be done at a lab near you so that you do not need to return to the clinic. In addition, during Week 5, you will need to stay in clinic for at least 6 hours after you take the study drug in order to complete research blood tests.
During your visits to the clinic, you may complete a physical exam, blood and urine tests for safety and for research, and cardiology (heart) tests for safety.
Eligibility Criteria (not a complete list):
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