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UC Davis Health Clinical Studies

Testing the Safety and Effectiveness of Experimental Sarilumab in Hospitalized Patients With COVID-19 (Coronavirus)

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You are being asked to take part in a research study because you have the COVID‑19 virus. This study will test the safety and effectiveness of the experimental drug, sarilumab (study drug). This study is sponsored by Regeneron Pharmaceuticals, Inc. (“Regeneron”). Sarilumab (also known as Kevzara®) is considered an experimental drug in this study. It has not been approved by the FDA for the condition being studied. However, it has been approved in multiple countries for active rheumatoid arthritis. Sarilumab is a type of drug called a “monoclonal antibody”. An antibody is a special kind of protein that your immune (defense) system normally makes to fight bacteria and viruses. Scientists can now make antibodies in the laboratory for the treatment of many different diseases. Sarilumab has been specifically shown to block the action of a protein called interleukin-6 (IL-6) in your body. Interleukin-6 (IL-6) is a protein in the immune system that has been shown to play an important role in inflammation. Inflammation may be associated with symptoms and complications of COVID‑19. The main purpose of this study is to determine if sarilumab is safe and if it can decrease the amount of time you have COVID-19 symptoms.

Drug study, Phase 2/3
Any, age 18 years or older

Experimental Treatment with Remdesivir for Patients Hospitalized With Coronavirus Infection (COVID-19)

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There are no approved medications to treat COVID-19 because it is a new disease caused by a virus that was just identified in 2019 in China. Some people who become sick with COVID-19 have serious disease and must be hospitalized. This study will test a drug in adult patients that are hospitalized with COVID-19. The drug has been tested before in humans with other diseases. In this study, we would like to make sure that it is safe for use in humans with COVID-19 and see if it can improve patients’ health when they are sick with COVID-19. We are studying the experimental use of a drug called remdesivir. This drug has been studied in animals and in people. It is given as an infusion, which means that it is given through a plastic tube attached to a needle that is put into a vein in the arm. To find out if remdesivir (the study drug) works, we need to compare it to getting something that does not have the drug in it, something called a placebo. The placebo looks like the study drug but does not have the drug in it. Using a placebo is common in research studies. The placebo is also given as an infusion. Some people in the study will get the placebo.

Other study, Phase 2
Any, age 18 to 99 years old

Experimental Niraparib With Radiation Therapy and Androgen Deprivation Therapy for High Risk Prostate Cancer

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This study is being done to answer the following question: Can we lower the chance of prostate cancer growing or returning by adding a new experimental drug to the usual treatment? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer that has a high chance of coming back. The purpose of this part of the study is to determine the ideal dose of the study drug. You are being asked to take part in the initial dose-finding part of this study (phase I). The purpose of this part of the study is to test the safety of the study drug niraparib added to usual treatment for your type of prostate cancer. The study drug is not approved by the FDA for use in patients with prostate cancer. We will test the safety of adding the study drug by looking at the side effects experienced by patients in this part of the study. If adding the study drug to usual treatment is safe, a second portion of the study (phase II) will open to additional patients. Phase II will compare any good and bad effects of the study treatment to the usual therapy. Researchers will use some of the information obtained from the patients in the dose-finding portion to find this out.

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

Experimental Erdafitinib for Relapsed/Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorder

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This is a Phase 2 study of an experimental drug called JNJ-42756493 (erdafitinib). In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on your tumor or type of cancer. We are using JNJ-42756493 (erdafitinib) in this study because it has been shown to block the growth of cancer cells with changes (mutations) in the FGFR1/2/3/4 genes. These mutations help cancer cells grow in test tubes and in animals. You are eligible for this study because your tumor was found to have a mutation in one of these genes. JNJ-42756493 (erdafitinib) is considered a study drug in the treatment of your tumor or type of cancer, we do not know if it will work against the type of tumor you have. A Phase 1 study of JNJ-42756493 (erdafitinib) has been completed in adults with cancer. In the Phase 1 study, researchers determined the dose of JNJ-42756493 (erdafitinib) can be given without too many side effects. This study will be the first time that JNJ-42756494 (erdafitinib) is given to children. The dose used in this study will be based on the dose used in adults. If you have bad side effects, your dose may be decreased. The goals of this study are: The main goal is to test any good and bad effects of the study drug JNJ-42756493 (erdafitinib) on your tumor. A second goal of the study is to evaluate side effects that might be caused by JNJ-42756493 (erdafitinib). Another goal is to learn more about the pharmacology (how your body handles the drug) of JNJ-42756493 (erdafitinib)

Drug study, Phase 2
Any, age 1 to 21 years old

Radiation Therapy With or Without Experimental Trastuzumab For Women With Ductal Carcinoma After Lumpectomy

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This study will test radiation therapy to see how well it works with or without experimental trastuzumab. It will be give to women with ductal carcinoma who have undergone lumpectomy (surgery to remove breast lump). Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. They can also carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma.

Other study, Phase 3
Female, age 18 years or older

A Study of Experimental Radiation Therapy With Cisplatin or Cetuximab for Oropharyngeal Cancer

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Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells. They either kill the cells or stop them from dividing. Monoclonal antibodies, such as experimental cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. This study will test radiation therapy with cisplatin or cetuximab. We hope to see how well it works in treating patients with oropharyngeal cancer.

Biological study, Phase 3
Any, age 18 to 120 years old

Experimental Antiandrogen Therapy and Radiation Therapy for Prostate Cancer

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The purpose of this study is to test the experimental medicine docetaxel. It will be compared to radiation therapy and hormone suppression therapy. This study drug is being tested in men with a high chance of prostate cancer recurrence after surgically removing the prostate. Docetaxel is FDA-approved for prostate cancer that has spread and does not respond to hormone suppression. In this study, docetaxel is being used off-label. Off-label means that the FDA has not yet approved docetaxel for this type of prostate cancer that has not spread. The addition of docetaxel to the usual radiation and hormone suppression therapy could shrink your cancer. It could prevent it from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study approach should decrease the chance of your cancer progressing by 30% or more compared to the usual approach.

Drug study, Phase [/2/,/ /3/]
Male, age 18 years or older

Testing an Experimental Anti-Cancer Drug M3814 for Relapsed or Refractory Acute Myeloid Leukemia

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This study is being done to answer the following question: Can we lower the chance of your acute myeloid leukemia growing or spreading by adding an experimental new drug to the usual combination of drugs? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your acute myeloid leukemia. The usual approach is defined as care most people get for acute myeloid leukemia.

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

An Experimental Combination Study of S1803, Daratumumab/rHuPh20 +/- Lenalidomide for Multiple Myeloma (MM)

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This study is being done to answer the following questions: 1. Will adding the experimetnal drug daratumumab/rHuPH20 to the usual maintenance treatment help multiple myeloma patients survive longer? 2. For patients who have no evidence of multiple myeloma in their bone marrow, should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma. The usual approach for patients who are not in a study is treatment with an FDA approved multiple myeloma drug (such as lenalidomide) after stem cell transplant.

Drug study, Phase 3
Any, age 18 to 75 years old
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