UC Davis Health Clinical Studies

Study of Experimental Sulbactam-ETX2514 Infections Caused by Acinetobacter baumannii-calcoaceticus Complex

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We are doing this study to test the effectiveness and safety of the experimental drug sulbactam-ETX2514. It is being tested for the treatment of infections caused by A. baumannii bacteria. This type of infection is usually resistant to many existing drugs. New drugs are needed to effectively fight A. baumannii bacteria. The study drug is not approved for the treatment of infections due to A. baumannii. The study drug itself is made up of two chemicals, one is called ETX2514, an investigational antibiotic. The other chemical that makes up the study drug is called sulbactam, an FDA-approved antibiotic. The combination that is this study drug is called “ETX2514SUL.”

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

Experimental Carboplatin & Paclitaxel With or Without Ramucirumab For Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma

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The purpose of this study is to compare any good and bad effects of using experimental ramucirumab. It will be given along with the usual chemotherapy combination (carboplatin and paclitaxel). Ramucirumab is FDA-approved for non-small cell lung cancer but not for thymic cancer. Ramucirumab in combination with carboplatin and paclitaxel is considered experimental. Ramucirumab is a monoclonal antibody. It is a type of protein made in the laboratory that can bind to substances in the body, including cancer cells. Ramucirumab targets the vascular endothelial growth factor receptor 2 (VEGFR 2). VEGFR2 is an important molecule that supports the growth of blood vessels by a process called angiogenesis. Growth of these blood vessels can feed tumors and cause them to grow. Ramucirumab blocks VEGFR2 and may prevent angiogenesis in advance thymic tumor patients. 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 extend the amount of time you are cancer-free compared to the usual approach. This chemotherapy combination, carboplatin and paclitaxel, has already been FDA-approved.

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

A Study of the Experimental Combination of Axitinib and Nivolumab For Unresectable or Metastatic Renal Cell Carcinoma

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In this study, we are interested in learning more about how to treat tRCC. To do this, we will test 2 drugs (axinitib and nivolumab) given alone or given together. The drugs axitinib and nivolumab have been used to treat adults and children with different types of cancer, including RCC. Axitinib is a chemotherapy drug that works by stopping the growth of new blood vessels to cancer cells. If left untreated, these feed the cancer cells and allow them to grow. Nivolumab is an immunotherapy that works by helping the body’s immune system (your body’s own defense system) to recognize and attack the cancer cells. Both axitinib and nivolumab have been approved by the FDA for treating RCC. However, using these 2 drugs together is considered experimental. Also, this will be the first formal study of treatments specifically for tRCC. We would like to know if using these drugs alone or together for the treatment of tRCC will be well-tolerated in subjects. Subjects are people who are agree to take part in this study. The overall goal of this study is to find out what effects, good and/or bad, axitinib and nivolumab have on subjects with tRCC when the drugs are given alone or in combination.

Drug study, Phase 2
Any, age 1 years or older

Experimental Standard Systemic Therapy With or Without Surgery or Radiation For Metastatic Prostate Cancer

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This study is being done to test if we can lower the chance of your prostate cancer growing or spreading. We will test adding either prostate removal surgery or radiation therapy to standard treatment. We hope to find out if this will be better or worse than the usual approach for your prostate cancer. This study will compare the effects of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST). SST is used to treat prostate cancer. Standard systemic therapy includes Androgen Deprivation Therapy (ADT). It is given with or without the use of chemotherapy. ADT is an antihormone therapy whose main use is in treating prostate cancer. The combination of SST and surgery or radiation therapy is considered experimental.

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

A Study of the Experimental Combination of Radiation Therapy and Olaparib For Inflammatory Breast Cancer

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The purpose of this study is to test adding the study drug (olaparib) to standard treatment. The addition of olaparib to standard treatment may or may not prevent your cancer from returning. This study will help study doctors learn if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients. The drug olaparib is approved by the FDA for use in other cancers. Olaparib is not approved for inflammatory breast cancer and is considered experimental in this study.

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

Experimental Combination of Olaparib and Radium-223 For Metastatic Castration-Resistant Prostate Cancer That Has Spread

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This study is for patients with metastatic castration resistant prostate cancer. In this study, we hope to learn if we can lower the chance of your prostate cancer growing or spreading. We will test the addition of the experimental drug, olaparib, to usual treatment with radium-223. We are doing this study because we want to find out if this approach is better or worse than the usual approach. The usual approach is defined as care most people get for metastatic castration resistant prostate cancer. The usual approach for patients who are not in a study is treatment with chemotherapy or hormone therapy. Sometimes, combinations of these treatments are used. Additional available options include radiation therapy for some individuals. Your doctor can explain which treatment may be best for you. These treatments can reduce symptoms and may stop the tumor from growing for a few months or longer.

Other study, Phase [/1/,/ /2/]
Male, age 18 years or older

A Study of the Drug Activity, Safety, and Tolerability of Experimental Ceftazidime-avibactam for Infections in Newborns & Infants

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You are being asked to take part in this study because your infant has or is suspected to have a bacterial infection. The infection requires treatment with IV antibiotics. The purpose of this study is to learn about the effects of the study drug combination of ceftazidime (CAZ) and avibactam (AVI). We hope to confirm the best dose for treating bacterial infections in infants and neonates. Ceftazidime (CAZ) is an antibiotic which is approved for use in infants and neonates. However, avibactam (AVI) is not approved for use in infants and neonates. The study drug, CAZ-AVI, is an experimental drug because it is not approved for use in neonates and infants from birth to less than 3 months of age.

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