|Age:||19 years or older|
|Keywords:||Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer, prostate cancer, Castration-Resistant Prostate Cancer, CRPC|
|Type:||Drug study, Phase 1|
If you choose to take part in this study, the following procedures may be required:
Take PDMX1001/niclosamide by mouth followed by 8 ounces of water. The dose of PDMX1001/niclosamide is 400 to 800 mg twice a day. PDMX1001/niclosamide can be taken with food. Always follow the instructions for use of PDMX1001/niclosamide given to you by your study doctor. You should take PDMX1001/niclosamide around the same time each day.
You will also take 4 enzalutamide capsules once a day by mouth (160 mg per day) with or without food. This medication is not study medications. They have been approved by the FDA. You will likely need to take these medications whether you participate in this study or not. Do not miss any capsules.
You will also be asked to complete a document called a pill diary. At the beginning of each cycle you will be given a pill diary. You will use the pill diary to track when you take your enzalutamide and PDMX1001/niclosamide. At the end of each cycle you will be asked to return the completed and signed pill diary, your pill bottles and any remaining PDMX1001/niclosamide to your study doctor. If your study doctor feels it is necessary or if you experience severe side effects, enzalutamide and/or PDMX1001/niclosamide may be stopped and then started again at a lower dose or may be stopped completely depending on the results of your laboratory tests.
Clinic visits will occur every 2 weeks during the first 4 weeks while on-study, and every 4 weeks from then on. At each visit, tell the study staff about any medications you are taking during the study. This includes prescriptions drugs, over-the- counter medicines and vitamins. This is very important. Please tell your study doctor or study staff if you have any unusual symptoms. You will be asked questions about your medical history and about any medications you are currently taking or have taken in the past. You will have a complete physical exam and your vital signs will be taken. You will be asked about your ability to perform every day activities. Up to 10 mL of blood will be taken (less than 1 tablespoon) for routine tests and will be collected every month. Repeat radiologic scans (an x-ray, if needed, and/or a CT and/or an MRI) will be taken every other month.
THE FOLLOWING PROCEDURES MAY BE INCLUDED IN THE STUDY:
-Complete medical history including history of prior diagnosis and treatment. -You will be asked about medications that you are currently taking, including over-the-counter medications, herbal remedies, vitamins, and supplements. -Physical examination, which includes measuring your temperature, blood pressure, height, weight, heart rate, breathing rate, and health status. -Evaluation of how well you are performing your day-to-day activities. -Computed tomography (CT) scan or MRI -Bone Scan -Chest X-ray -EKG/ECG. An ECG (electrocardiogram) is a test that measures the electrical activity of the heart. Collection of archived tumor specimen for research purposes -Blood tests for routine laboratory tests (approximately 2 teaspoons / 10 mL). -Blood tests for blood chemistries (approximately 2 teaspoons/ 10 mL). -Blood test to check for PSA and serum testosterone (approximately 2 teaspoons/ 10 mL). -Blood test for correlative research studies (approximately 4 teaspoons/ 19 mL). -Urine test to check for protein level in your urine.
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