Clinical trials located in

Bologna

Bologna city is located in Italy. Currently, 20 clinical trials are being conducted in this city.

Bologna, nestled in Italy’s Emilia-Romagna region, is renowned for its rich history, vibrant culture, and culinary excellence. Established by the Etruscans in the 6th century BC, it houses the world’s oldest university, the University of Bologna, founded in 1088. The city’s distinctive medieval architecture is highlighted by the Two Towers, Asinelli and Garisenda, which lean dramatically. Bologna’s porticoes, spanning over 38 kilometers, offer unique covered walkways that are a UNESCO World Heritage site. Esteemed for its gastronomy, Bologna is the birthplace of iconic dishes like tagliatelle al ragù, known worldwide as Bolognese sauce.

  • CT-EU-00121743

    Study comparing Giredestrant and Fulvestrant with CDK4/6 Inhibitors for advanced breast cancer

    This study focuses on a type of advanced breast cancer known as Estrogen Receptor-Positive (ER+), HER2-Negative breast cancer. This kind of cancer is driven by hormones and does not have high levels of the HER2 protein. The study aims to evaluate the effectiveness and safety of a new drug called Giredestrant compared to an existing drug called Fulvestrant. Both drugs will be combined with one of three medicines that inhibit proteins in cancer cells called CDK4/6 inhibitors (Palbociclib, Ribociclib, or Abemaciclib).

    In this study, participants will be randomly assigned to one of two groups. One group will receive Giredestrant and the other will receive Fulvestrant. Both groups will also receive one of the CDK4/6 inhibitors chosen by their doctor. These combinations are being tested to see which works better to stop the cancer from growing or spreading.

    The drugs involved include Giredestrant (RO7197597, RG6171, GDC-9545), Fulvestrant, Abemaciclib, Palbociclib, Ribociclib, and LHRH Agonist (for pre/perimenopausal women and men).

    The goal is to find out if Giredestrant can provide better results and fewer side effects compared to Fulvestrant when both are combined with one of the CDK4/6 inhibitors. The study may involve regular tests and assessments to monitor the cancer’s progress and the patient’s response to the treatment.

    Participants will continue to receive the study drugs as long as they are benefiting from them and not experiencing unacceptable side effects. The study involves close monitoring to ensure the safety and well-being of all participants throughout the treatment period.

    • LHRH Agonist
    • Abemaciclib
    • Giredestrant
    • Palbociclib
    • Ribociclib
    • Fulvestrant
  • Study of the safety and effectiveness of GLSI-100 in patients with HER2-positive breast cancer

    The study concerns the treatment of patients with HER2/neu-positive breast cancer. Treatment will include GLSI-100 immunotherapy and comparison to placebo. GLSI-100 consists of GP2 peptide and GM-CSF, protein substances that are designed to strengthen the body’s immune response, i.e. natural protection against diseases.

    The aim of this study is to determine how effective and safe GLSI-100 therapy is compared to placebo in preventing breast cancer recurrence after standard treatment. The study is aimed at people at high risk of disease recurrence who have completed both preoperative and postoperative therapy based on trastuzumab, a drug used to treat breast cancer.

    The study will assess invasive breast cancer-free survival (i.e. the time from the first dose of the drug to the moment of disease recurrence or death from any cause), invasive disease-free survival (i.e. the time from the first dose of the drug to the moment of any disease recurrence or new cancer), remote disease (i.e. time until disease recurrence in a place other than the breast or death).

    The study also includes an assessment of the participants’ quality of life both at the beginning and over the next 36 months, as well as an analysis of the body’s immune response to treatment.

  • Study of Trabectedin for Advanced Mesenchymal Chondrosarcoma

    Mesenchymal chondrosarcoma is a rare type of cancer that affects the connective tissues in the body, often found in bones or soft tissues. This study focuses on the potential benefit of a drug called trabectedin for patients aged 16 and older who have advanced mesenchymal chondrosarcoma that has either progressed locally or spread to other parts of the body, and who have already received at least one previous chemotherapy treatment.

    The purpose of the study is to explore the activity of trabectedin in treating this specific type of cancer. Trabectedin will be given through a continuous 24-hour infusion. The dose will be determined by the investigator, with the range being from 1.3 mg/m² to 1.5 mg/m² per cycle. Each participant will receive the treatment as the only experimental therapy in the study.

    Patients will be monitored at regular intervals to assess their response to the treatment and its effectiveness over time. The study will also track any adverse effects from the treatment, aiming to understand both the potential benefits and risks of using trabectedin for this cancer type.

    The study aims to provide more information on how trabectedin works in treating mesenchymal chondrosarcoma, which could potentially lead to better treatment options for patients with this rare and challenging disease.

    • Trabectedin
  • Study of Tobemstomig and supportive medications for patients with advanced or metastatic triple-negative breast cancer

    The clinical trial is for patients with triple-negative breast cancer (TNBC) that is locally advanced, inoperable or metastatic (stage IV) and has not been previously treated. The study compares a new immune therapy, Tobemstomig (RO7247669), in combination with Nab-Paclitaxel, and Pembrolizumab.

    The aim of the study is to assess the effectiveness and safety of the therapy. Patients will be randomly assigned to one of two groups: in the first group, patients will receive Tobemstomig every three weeks and Nab-Paclitaxel for three weeks, followed by a week off. In the second group, patients will receive Pembrolizumab every three weeks and Nab-Paclitaxel for three weeks, followed by a week off. Therapies will be continued until disease progression or for a maximum of 24 months from the start of treatment.

    The study is aimed at adults aged 18 and over who are well enough to be eligible for treatment. The presence of appropriate markers in the tumor tissue is also required. Patients cannot participate in the study if they have ongoing infections, uncontrolled health problems, or are pregnant.

    • Tobemstomig
    • Pembrolizumab
    • nab-Paclitaxel
  • Study of INBRX-109 for patients with unresectable or metastatic conventional chondrosarcoma

    Conventional chondrosarcoma is a type of cancer that affects the bones. This clinical trial focuses on evaluating a new treatment for patients with unresectable (inoperable) or metastatic (spread to other parts of the body) conventional chondrosarcoma. The therapy being tested is called INBRX-109. INBRX-109 is an experimental drug, specifically a humanized antibody that targets a protein called death receptor 5 (DR5). The study aims to determine whether INBRX-109 can help patients who have this type of bone cancer.

    In this study, participants will be randomly assigned to one of two groups: one group will receive INBRX-109, and the other will receive a placebo. Neither the participants nor the researchers will know who is receiving the actual drug and who is receiving the placebo. This is known as a double-blind study. Participants will receive their assigned treatment through an intravenous infusion every three weeks. If the disease progresses, those in the placebo group will be allowed to switch to the INBRX-109 treatment.

    The primary goal of the study is to see how well INBRX-109 works in preventing the cancer from getting worse. The study will also look at overall survival rates, how long any responses to the treatment last, and the quality of life of the participants during the study. Safety and tolerability of INBRX-109 will also be evaluated by monitoring for any side effects. Participants will have regular visits and tests to check on their condition and the effects of the treatment. This clinical trial offers a potential new treatment option for patients with difficult-to-treat chondrosarcoma, aiming to improve their outcomes and quality of life.

    • INBRX-109
    • placebo
  • Testing BI 764198 for Kidney Disease (FSGS): A 4-Month Study

    This study is focused on individuals with a kind of kidney disease called Focal Segmental Glomerulosclerosis (FSGS). The purpose is to see if a drug named BI 764198 can improve kidney health for people with FSGS. There will be three different doses of BI 764198 tested in the study.

    Participants in the study will be divided into four groups randomly. Three groups will receive different doses of BI 764198, and one group will receive a placebo. The study will last about four months. For approximately three months, participants will take a BI 764198 capsule or placebo capsule daily.

    Participants will visit the study site around ten times. It is possible to participate from home, in which case a research nurse will visit for the study visits. Kidney health will be checked by analyzing urine samples that participants collect at home. The results will be compared between the different groups at the end of the study. Throughout the study, doctors will also regularly monitor the general health of participants.

    • BI 764198
    • placebo
  • Long-term safety and efficacy study of PTC518 for Huntington’s disease

    This study focuses on Huntington’s Disease and evaluates the long-term safety and effectiveness of the drug PTC518. Participants, who have previously completed related study phases, will continue taking PTC518 in doses of 5, 10, or 20 milligrams. The study aims to monitor the safety of long-term use and assess how the drug impacts biological markers and symptoms of the disease over a period of 30 months. This is an extension study where all participants will receive the active drug, ensuring continuous monitoring and evaluation of its effects.

    • PTC518
  • Study on Secukinumab for Rotator Cuff Tendinopathy

    This clinical trial evaluates the efficacy of the drug secukinumab in treating moderate to severe rotator cuff tendinopathy. Participants will receive secukinumab or a placebo, both in conjunction with standard care, to see if there is an improvement in symptoms and physical function. The research is conducted through a controlled setup where neither the participants nor the researchers know who receives the drug or the placebo to ensure unbiased results. This research aims to provide valuable insights into the potential benefits of secukinumab for those struggling with this shoulder condition.

    • placebo
    • Secukinumab
  • Study of Fidrisertib/IPN60130 in the treatment of Fibrodysplasia Ossificans Progressiva (FOP)

    The aim of this study is to test a new drug called fidrisertib (also known as IPN60130) to treat a rare disease called Fibrodysplasia Ossificans Progressiva, or FOP. FOP is a grave disease that causes bones to start growing in places they shouldn’t, such as muscles and soft tissues. This causes a lot of pain, swelling, and stiffness in the joints, making movement difficult.

    In the study, some participants will be given the new drug fidrisertib at two different doses, and others will be given a dummy treatment called a placebo. Researchers will monitor the situation closely, performing special tests called low-dose whole-body computed tomography (WBCT) to measure new bone growth. For some older participants, they may also use another type of test called fluorine-18-labeled sodium fluoride positron emission tomography – computed tomography to check bone growth.

    • IPN60130
    • placebo
  • To evaluate the effectiveness of nivolumab used alone and in combination with HBI-8000 in the treatment of unresectable or metastatic melanoma

    This is a study comparing two treatment options for patients with melanoma that cannot be surgically removed or has spread to other parts of the body. One treatment option is an investigational drug called Tucidinostat (HBI-8000) taken by mouth twice a week in combination with an approved drug called nivolumab given by intravenous infusion. Another option is a placebo taken orally twice a week, also in combination with nivolumab given by intravenous infusion.

    The primary goal of the study is to determine whether the combination of HBI-8000 and nivolumab is more effective than nivolumab alone in shrinking the tumor or preventing further tumor progression. The study will also assess the safety of the treatment combinations.

    Patients enrolled in the main study will be randomly assigned to receive either the HBI-8000 combination or a placebo combination. Treatment will continue for up to 2 years or until the cancer progresses, side effects worsen or the patient decides to withdraw from the study. The study will last up to 4 years and will include regular monitoring and follow-up visits.

    • Placebo
    • Tudicdinostat/HBI-8000
  • Study of KRT-232 Combined with Ruxolitinib for Myelofibrosis Patients

    This here clinical trial is looking at a new drug called KRT-232 that’s taken by mouth. The study aims to see if combining KRT-232 with the existing drug ruxolitinib can help folks with myelofibrosis who ain’t responding well enough to just taking ruxolitinib alone.

    The main goal in the first part of the study is to find the right dose of KRT-232 to use when combined with ruxolitinib. They’ll be looking closely at any side effects to make sure the dose is safe. In the second part, they’ll check if the combination of the two drugs can shrink the size of the spleen by at least 35% after 6 months of treatment.

    • KRT-232
    • Ruxolitinib
  • Study of TL-895 Combined with Ruxolitinib for Myelofibrosis Treatment

    This here clinical trial is studying a new experimental drug called TL-895 for the treatment of myelofibrosis. TL-895 works by blocking certain proteins called tyrosine kinases that are involved in the growth of cancer cells. The study is open to folks who have myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.

    Participants in the study will take TL-895 along with another drug called ruxolitinib, which is already approved for treating myelofibrosis. Ruxolitinib, also known as Jakafi or Jakavi, works by blocking different proteins called Janus kinases that are also involved in cancer growth.

    The main goal of the study is to find the best dose of TL-895 to use with ruxolitinib that is both safe and effective. In the first part, different doses of TL-895 will be tested to determine the highest dose that can be tolerated without causing too many side effects. Then in the second part, the recommended dose will be given to all participants, and the researchers will measure how well the combination of drugs reduces spleen size after 24 weeks of treatment.

    So in a nutshell, this study aims to test a new targeted therapy for myelofibrosis by combining it with an existing approved drug, with the hope of improving treatment outcomes for patients with this serious blood disorder.

    • TL-895
    • Ruxolitinib
  • Study on INCB000928 Alone or With Ruxolitinib for Anemia in Myeloproliferative Disorders

    This clinical trial is designed to explore the effects of a new medication called INCB000928, either on its own or when used together with another drug known as ruxolitinib. The main goal is to see how safe and tolerable this treatment is for individuals suffering from anemia due to certain myeloproliferative disorders, including conditions like post-essential thrombocythemia myelofibrosis and post-polycythemia vera myelofibrosis. These are types of blood disorders that can lead to symptoms such as fatigue due to anemia.

    The study is divided into two parts: the first part will focus on finding the right dose of the medication, and the second part will expand on these findings to further understand the treatment’s effects. Participants in this study will be closely monitored to assess any side effects and to see how well the treatment is working, with a particular focus on how it impacts anemia and the need for blood transfusions.

    This research is being conducted in an open-label which means both the researchers and participants will know which treatment is being administered. The safety, tolerability, and effectiveness of INCB000928, both as a standalone therapy and in combination with ruxolitinib, will be evaluated over approximately 13 months. This study represents an important step towards finding new treatments for those dealing with the challenges of anemia due to myeloproliferative disorders.

    • Ruxolitinib
    • INCB000928
  • Study on the Safety and Effectiveness of INCB057643 for Myelofibrosis and Other Myeloid Neoplasms

    This clinical trial is focused on evaluating the safety, tolerability, and initial effectiveness of a medication called INCB057643, either on its own or in combination with another drug known as ruxolitinib. It is designed for participants who are dealing with myelofibrosis or other advanced myeloid neoplasms, which are types of blood disorders. The study aims to understand how well participants can handle the treatment and to observe any potential benefits or side effects that may occur during the trial. The treatment’s impact will be measured by monitoring the number of treatment-related adverse events, which includes any new or worsening symptoms following the start of the medication. This study is an important step towards finding new treatment options for individuals with myelofibrosis and related conditions, offering hope for better management of these diseases.

    • INCB057643
    • Ruxolitinib
  • Comparison of zibotentan/dapagliflozin with dapagliflozin alone in the treatment of chronic kidney disease with high proteinuria

    The study aims to understand how to better treat people with chronic kidney disease (CKD) and high proteinuria. This study is in its third phase and involves multiple centers where participants will be closely monitored. The main goal is to compare the effectiveness, safety, and how well participants tolerate a combination treatment of zibotentan/dapagliflozin versus dapagliflozin alone.

    During this study, participants will be randomly assigned to one of two groups. One group will receive the combination of zibotentan and dapagliflozin, while the other group will receive only dapagliflozin. Both treatments aim to slow down the decline in kidney function, which is a major concern for people with CKD and high proteinuria. The key measure of success for this study is the change in eGFR from baseline, which is a test used to check how well the kidneys are working, specifically by measuring the estimated glomerular filtration rate (eGFR). This will be assessed at the 24-month mark of the study.

    This research is crucial because it could lead to better treatment options for those suffering from CKD and high proteinuria, potentially improving their quality of life and health outcomes.

    • Zibotentan/Dapagliflozin
    • Dapagliflozin
  • Study on Ravulizumab’s effect on Immunoglobulin A Nephropathy

    The study is looking into the effectiveness of a medication called ravulizumab for adults who have a kidney condition known as Immunoglobulin A Nephropathy (IgAN). This condition can lead to kidney damage over time, and the study aims to find out if ravulizumab can help reduce the amount of protein lost in urine—a common problem in IgAN—and slow down the decrease in kidney function.

    In this study, about 450 participants who are at a high risk of their disease getting worse will be chosen. These participants must have been on stable treatment for their IgAN for at least three months before the study starts. They will then receive either ravulizumab or a placebo, which is a treatment with no active drug, through an IV infusion based on their weight. The main goal is to see if those who receive ravulizumab have a significant improvement in their condition compared to those who receive the placebo.

    The study will have two main checkpoints. The first one, at Week 34, will check how much protein is in the urine, and the second one, at Week 106, will assess how well the kidneys are filtering waste from the blood. Additionally, a smaller group of participants with more advanced kidney issues will receive ravulizumab to further explore its effects.

    After the study ends at Week 106, participants will have the option to continue receiving ravulizumab in a follow-up period to see how long-term treatment affects their condition. This study is a chance for people with IgAN to potentially slow down their disease progression and improve their quality of life.

    • placebo
    • Ravulizumab
  • CT-EU-00053821

    Testing the safety and efficacy of Rapcabtagene autoleucel in combination with ibrutinib for the treatment of various leukemia

    This study is looking at a new drug called rapcabtagene autoleucel in people with different types of blood cancer. The treatment is divided into two phases. In phase I, the study is testing the safety and efficacy of the new treatment in three different patient groups. The first group is adults with CLL/SLL, a type of blood cancer that has not shown a good response to the drug ibrutinib. The second group is adults with DLBCL, another type of blood cancer, who have failed at least two other treatments and who are unable or unwilling to undergo a stem cell transplant. The third group is adults with ALL, another type of blood cancer, who have not responded to other treatments. Phase II extends Phase I, focusing on the two main groups. The aim of this part is to obtain additional information on the efficacy of the new treatment. The aim of both phases is to determine the best dose of rapcabtagene autoleucel, to see how safe it is and how well it works against these tumors. After the treatment part of the study is completed, patients will be followed up for at least two years to monitor their health status and the long-term effects of the treatment.

    • Rapcabtagene autoleucel/YTB323
    • Ibrutinib
  • Research to enhance cancer treatments for kids and teens

    This clinical trial, known as CAMPFIRE, encompasses several studies testing new drugs for children and young adults with cancer. It includes various drug combinations such as Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, Docetaxel, Abemaciclib, Irinotecan, and Temozolomide. These trials aim to evaluate the safety and effectiveness of these drugs in treating different cancer types. The study is interventional, with an estimated enrollment of 105 participants, randomized in parallel assignment. The primary purpose is treatment-focused.

    • Abemaciclib
    • Temozolomide
    • Irinotecan
    • Ramucirumab
    • Gemcitabine
    • Vinorelbine
    • Cyclophosphamide
    • Docetaxel
  • Studying rilzabrutinib for chronic immune thrombocytopenia

    The research is underway to evaluate the efficacy and safety of a medication called rilzabrutinib in adults and teenagers with Immune Thrombocytopenia (ITP), a chronic blood condition characterized by a low platelet count. Participants will receive either the medication or a placebo twice daily over a period of about a year and a half. Platelet levels, overall health, and quality of life will be measured before and during the study to gather comprehensive data.

    • Rilzabrutinib
  • Continued Parsaclisib treatment for B-cell cancer patients

    This is a phase II clinical trial focused on providing continuation of treatment with a drug called parsaclisib to people diagnosed with B-cell malignancies. The main goal of this study is to expand the treatment regimen established in the previous study. Study participants will receive parsaclisib as a stand-alone therapy (monotherapy) or in combination with other therapeutic agents, which may include itacitinib, ruxolitinib or ibrutinib. The study aims to facilitate participants’ ongoing care and contribute to the broader field of medical research by collecting data on the effectiveness and safety of prolonged use of parsaclisib.

    • Ibrutinib
    • Ruxolitinib
    • Itacitinib
    • Parsaclisib

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