Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer

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Age: 19 years or older
Healthy Volunteers: No
Keywords: Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer, prostate cancer, Castration-Resistant Prostate Cancer, CRPC
Type: Drug study, Phase 1
9 Participants
This phase I trial studies the best dose and side effects of niclosamide when given with enzalutamide. The study treatment is for castration-resistant prostate cancer that has come back or has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer. It does this by lowering the amount of androgen the body makes. It may also block the use of androgen by the tumor cells. Niclosamide may block signals that enhance prostate cancer cell growth. Enzalutamide and niclosamide may work better in treating patients with castration-resistant prostate cancer.
This study requires

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.


-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´éč -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.

Who can participate

Inclusion criteria:

  • Patients must have histologically or cytologically confirmed carcinoma of the prostate (CaP); CaP can be recurrent disease after definitive therapy (radical prostatectomy or radiation therapy) for localized CaP, or metastatic CaP
  • Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable):
  • Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug
  • Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans)
  • Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (2nd beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
  • Measurable disease is not required:
  • Patients who have measurable disease must have had X-rays, computed tomography (CT) scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug
  • Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drug
  • Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease
  • If PSA is the only indicator of disease without any evidence of metastasis, PSA value must be 5.0 or higher
  • Expression of AR-V7 is not required as expression of AR-V7 can occur during enzalutamide and contribute to resistance to enzalutamide
  • Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (< 50 ng/dL) within 3 months prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy should be deemed greater than 6 months
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
  • Creatinine =< 1.5 x institutional upper limit of normal
  • Men treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of enzalutamide and PDMX1001/niclosamide administration
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients who have received any other investigational agents within the preceding 4 weeks
  • Patients taking herbal or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, prostate cancer (PC)-SPES
  • Patient has received enzalutamide for the treatment of prostate cancer; however, previous treatment with other hormonal therapy (bicalutamide, flutamide, nilutamide, abiraterone and ketoconazole) or chemotherapy (docetaxel, cabazitaxel or mitoxantrone) is allowed
  • Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancers
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or PDMX1001/niclosamide
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Patients with an active, bleeding diathesis
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
  • Patients with symptomatic metastatic prostate cancer experiencing moderate to severe pain, impaired organ function or spinal cord compression will be excluded from this study unless these issues have been addressed
Benefits and risks of participating
You may not benefit from taking part in this research. The information we get from this study may help us to learn more about this study treatment, and this may help future cancer patients.

Your doctor will discuss the risks associated with this research study.
You will not be compensated for your participation in this study.
Study duration and period
You will be asked to take part for as long as your cancer is not growing and you are not having any unmanageable side effects. After you are finished taking enzalutamide and niclosamide, your doctor will ask you to visit the office for follow-up exams at least once. After that, we will continue to collect follow-up information about your cancer and any further treatment you receive for the rest of your life.
Recruitment period
From Jan. 9, 2017
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Leigh Anne Morris

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