UC Davis Health Clinical Studies

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

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

A Study of the Experimental Medicine ANAVEX2-73 For Rett Syndrome

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This research is being done to answer important questions that might help change or improve treatment for Rett Syndrome. Rett syndrome (RTT) is a rare genetic progressive neurodevelopmental disorder. It is mostly linked to mutations in the MECP2 gene. This affects multiple brain functions including communication, gait, and hand use. Because the MECP2 is gene is on the chromosome, few males live past birth. Therefore, most affected individuals with RTT are females. RTT becomes evident between 1.5-3 years of life. Signs are early developmental regression, expressive language and fine motor (hand) function difficulties . Other clinical manifestations are: - repetitive hand movements - impairment in ambulation - severe intellectual disability - breathing abnormalities while awake - seizures - sleep problems - behavioral problems such as anxiety, disruptive behavior, and mood abnormalities. The experimental drug being tested in this study is called ANAVEX®2-73. Since it is still being studied (experimental), it is not yet approved by the U.S. Food and Drug Administration (FDA), and doctors cannot prescribe it. We want to get more information about how ANAVEX®2-73 might: - improve cognition and sleep, - decrease anxiety and other behaviors, - improve motor function and seizures, if applicable in people with RTT.

Drug study, Phase 2
Female, age 18 to 45 years old

A Study to Test the Effectiveness and Safety of Experimental Padsevonil for Seizures in Adults With Drug-Resistant Epilepsy

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Seizures are caused by abnormal electrical disturbances in the brain. Focal-onset seizures occur when this electrical activity remains in a limited area of the brain. Seizures can sometimes turn into generalized seizures (also called Grand Mal seizures), which affect the whole brain. The purpose of this study is to test the effectiveness, safety, and tolerability of a new experimental drug called padsevonil. The study drug will be given in one of 3 different doses along with your current epilepsy treatment that may consist of 1-3 antiepileptic drugs. The study also aims to see how safe padsevonil is compared to placebo and how well your body can tolerate it. This study involves the use of both padsevonil and placebo tablets that look exactly the same. The placebo does not contain any active ingredients. Placebo as well might have effect on your seizures and wellbeing. You have an equal chance (like rolling a dice) of being assigned to one of the 4 treatment groups: - padsevonil 200 mg/day, - padsevonil 400 mg/day, - padsevonil 800 mg/day or - placebo. Padsevonil is a medicine particularly made to better control seizures in people who are resistant to other anti-seizure drugs. It has not yet been approved by drug authorities such as FDA, for the treatment of any disease, including focal-onset seizures.

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

Experimental Combination of Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel For Advanced Biliary Tract Cancers

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Biliary cancer is a form of cancer that develops in the bile duct system. This system connects the liver, gallbladder, and small intestine. The biliary ducts move bile, a fluid that helps digest fats, to the small intestine. The purpose of this study is to compare the effects of an experimental combination treatment. I twill be used to treat newly Diagnosed, Advanced Biliary Tract Cancers. The drug nab-paclitaxel will be added to standard treatment with the drugs cisplatin and gemcitabine. This treatment will be compared to treatment with cisplatin and gemcitabine alone. Nabpaclitaxel is an FDA-approved drug for other diseases. It is experimental in this study. The addition of the study drug nab-paclitaxel could shrink your cancer. It could also cause side effects. This study will help the study team learn whether this different approach is better, the same, or worse than standard treatment. In this study, you will get either: - cisplatin and gemcitabine, or - nab-paclitaxel with cisplatin and gemcitabine.

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

Experimental Study of a New Drug Combination - Copanlisib and Fulvestrant - in Postmenopausal Women With Advanced Breast Cancer

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The purpose of this study is to compare any good and bad effects of using a specific drug, copanlisib. It will be given along with standard therapy with fulvestrant for advanced breast cancer. The addition of copanlisib to the usual therapy of fulvestrant alone could shrink your cancer/prevent it from returning. It could also cause side effects. The genetic make up of your breast cancer will be important to know before you start treatment in the trial. If you have a protein called PI3K or PTEN, copanlisib may work better when given with fulvestrant to block cancer cell growth. PI3K and PTEN are often altered (or mutated) in cancer cells. If you do not have PI3K or PTEN alterations in your tumor you may still benefit from this therapy. Researchers hope to learn if tumor genetic information is important in predicting if your cancer will respond to fulvestrant and copanlisib. 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 addition of copanlisib should shrink breast tumors in about 1 out of every 3 patients treated on this study. Copanlisib is already FDA approved for use in follicular lymphoma. It is usually not used for the treatment of breast cancer and is considered experimental in this study.

Drug study, Phase [/1/,/ /2/]
Female, age 18 years or older

Experimental Iobenguane I-131 or Crizotinib and Standard Therapy For Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma

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In this study, researchers want to find out if we can improve the treatment for subjects with high risk Neuroblastoma (NBL). We will study the addition of experimental drug I-MIBG or the experimental drug Crizotinib to standard therapy. We also want to find out if we can reduce the number of stem cell transplants from two to one. I-MIBG is an experimental anticancer drug. It has not been approved by the FDA for use in treating high-risk NBL. I-MIBG has been used to treat NBL that did not respond to therapy or NBL that has come back. I-MIBG has been shown to be well tolerated in children with cancer. I-MIBG can only be given at certain hospitals and you may need to travel to another hospital if you choose to participate in this study. Some patients in the study will receive only one stem cell transplant instead of two back-to-back stem cell transplants. Subjects who have only one stem cell transplant will get two chemotherapy drugs called busulfan and melphalan (BuMel). These are given instead of the drugs usually used for back-to-back stem cell transplants. BuMel is an accepted transplant chemotherapy regimen in Europe and other parts of the world. It is not part of current Children's Oncology Group (COG) recommended therapy. Crizotinib is an experimental anticancer drug. It has not been approved by the FDA for use in treating high-risk NBL. Crizotinib has been approved by the FDA for use in treating adults with certain types of lung cancer that has spread. Crizotinib has been well-tolerated in children and adults with cancer. Crizotinib will only be used in subjects whose tumor shows changes in a gene called ALK. Changes in the ALK gene are only found in 10-15% of children with high-risk NBL. The overall goals of this study are to: • Compare the effects, good and/or bad, of the experimental drug I-MIBG added to current COG recommended therapy. • Compare the effects, good and/or bad, of the experimental drug crizotinib added to current COG recommended therapy. Another goal of this study is to: • Evaluate the effects, good and/or bad, of using the experimental drug I-MIBG in the setting of single cell transplant with BuMel conditioning during Consolidation therapy. These effects, good and/or bad, will be studied but will not be directly compared to current COG recommended therapy.

Biological study, Phase 3
Any, age -1 to 30 years old
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