UC Davis Health Clinical Studies

A Study of the Safety and Activity of Experimental ABBV-744 For Metastatic Prostate Cancer and Acute Myeloid Leukemia

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This is a research study for an experimental drug called ABBV-744. It will be studied in patients with relapsed/refractory acute myeloid leukemia (AML). An investigational drug is one that has not been approved by the FDA. The purpose of this study is: - to see if ABBV-744 is safe - to determine a safe dose of ABBV-744 - to see how much ABBV-744 is in your blood at various times (these tests are called "pharmacokinetics" or "PK") - to determine if treatment with ABBV-744 leads to tumor shrinkage. This study is for patients with relapsed (cancer has returned) or refractory (cancer is not responding to treatment) acute myeloid leukemia. The study sponsor (AbbVie) requests that we site collect tissue samples (including blood samples and tumor biopsies) for research purposes. This can help researchers (including your doctor and AbbVie) to better understand why certain people respond differently to ABBV-744. This is called “biomarker” research. ABBV-744 is a drug called a Bromodomain and extra-terminal (BET) inhibitor. BET proteins read DNA modifications that determine which genes are active. ABBV-744 interferes with this reading. If reading such DNA modifications are needed for the survival and growth of cells in a tumor, the tumor may be slowed or stopped.

Drug study, Phase 1
Any, age 18 years or older

A Study of the Effects of Chemotherapy on Fertility in Osteosarcoma (bone cancer) Survivors

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Incredible progress has been made in curing childhood cancers over the past 20 years. With all this success has come the awareness that childhood cancer treatment may lead to complications in some patients. This study is for patients who have previously received treatement for osteosarcoma (a type of bone cancer). Some chemotherapy drugs cause fertility problems (difficulty fathering children) in male patients. We do not know if cisplatin with or without ifosfamide causes similar problems. Problems may occur later in life for patients initially treated as adolescents and young adults. We are doing this study to learn more about possible long-term effects. The main goals of this study are: • To look at potential effects on fertility in male osteosarcoma survivors treated with cisplatin with or without ifosfamide. This will be compared to male controls without a history of cancer. • To learn whether cisplatin with or without ifosfamide changes the DNA in sperm. The other goal of this study is: • To explore how a person’s genetic makeup might change the effects that treatments for osteosarcoma have on male fertility.

Procedure study
Male, age 18 to 50 years old

A Study of Experimental Radiation Therapy With or Without Apalutamide For Stage III-IV Prostate Cancer

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This research study is for patients with prostate cancer who had surgery to remove the prostate. If your PSA level (a measure of prostate cancer) shows that your cancer has returned, this study may be right for you. People who are not in a study are usually treated with radiation therapy alone. Some patients may also receive hormone suppression drugs. However, these drugs are FDA approved for more advanced prostate cancer or prostate cancer that has spread. Therefore, hormone suppression drugs are usually not given. For patients who receive the usual approach (radiation therapy alone), about 62 of 100 patients are free of cancer after 5 years. This study will compare the effects of using the experimental drug apalutamide (study drug). It will be given along with usual radiation therapy. This combination treatment will be compared to using usual radiation therapy alone. The study drug is a hormone suppression drug. The study drug is experimental and is not FDA-approved to treat prostate cancer. The addition of the study drug to usual radiation could shrink your cancer/prevent it from returning, but could also cause side effects. This study will allow researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should reduce the chance of your cancer growing back compared to the usual approach.

Drug study, Phase 2
Male, age 18 years or older

A Study of Experimental Stereotactic Body Radiation Therapy (radiation treatment in a shorter amount of time) For Prostate Cancer

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This study will compare any good and bad effects of using stereotactic body radiation therapy (SBRT). SBRT gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment may prevent the tumor from returning but it could also cause side effects. This study will test whether using SBRT is better, the same, or worse than the usual approach.

Radiation study, Phase 3
Male, age 18 years or older

A Study of the Effects of Intermittent Fasting on Energy, Hormones, Body Composition, and Performance in Male Runners

The study team hopes to learn more about how time restricted eating affects performance and health in male runners.

This study is designed to test the effects of four weeks of time restricted feeding (16 hours fasting and 8 hours feeding). These effects will be compared to four weeks of a more traditional eating pattern (12 hours fasting and 12 hours feeding). The study team will look at the following in male competitive runners: • Resting energy expenditure • Blood markers of metabolism and hunger • Body composition • Cardiovascular health • Substrate utilization (carbohydrate and fat burning) • Fitness

Behavioral study
Male, age 20 to 40 years old

HIV Post-Exposure Prophylaxis Uptake and Adherence Post-Sexual Assault

Looking for men and women who have been offered medications to prevent HIV following sexual assault

Thank you for your interest in taking part in the My Experiences Navigating Daily-life (MEND) research study. The purpose of this study is to get information about how and why people do or do not take HIV post-exposure prophylaxis (PEP) (medications to prevent HIV) in the four weeks after a sexual assault. Your participation will involve taking a survey via an internet-based web-application. Completing this survey means you consent to participate in this study. There are two parts to the survey: a screening section and the main survey. After finishing the screening section, you may or may not be selected to complete the main survey. The main survey will take about 30-45 minutes to complete. You can complete the survey two ways: (1) anonymously, or (2) you may choose to provide your email address to receive a gift card for your time.

Online survey
Any, age 18+

A Study of Experimental Combination of Enzalutamide and Indomethacin For Recurrent or Metastatic Hormone-Resistant Prostate Cancer

This is a research study for patients with prostate cancer that has become resistant to first-line androgen deprivation therapy.

You are being asked to take part in this study because you have prostate cancer. Your cancer has become resistant to the first-line androgen deprivation therapy. We call this castration-resistant prostate cancer or CRPC. It has also become resistant to another FDA-approved medication abiraterone. This study will determine if the combination of enzalutamide (a FDA-approved medication for CRPC) and indomethacin (a FDA-approved medication for pain) can improve the treatment outcome of CRPC. This will be compared to enzalutamide therapy alone. Enzalutamide and indomethacin have been used in clinic but we have not studied them together. During the first stage, we will determine the dose and schedule of these two drugs. After we know the dose and schedule, the safety and efficacy of the combination of these drugs will be studied. We will study the following to help us decide if the combination of enzalutamide and indomethacin is safe and effective: - Your physical state - Changes in the size of the tumor - Laboratory tests

Drug study, Phase [ 1 , 2]
Male, age 19 years or older

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

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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.

Drug study, Phase 1
Male, age 19 years or older
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