Country: Romania

Currently showing 20 clinical trials. Use pagination links to see more trials.

  • CT-EU-00117746

    Study of Pembrolizumab/Quavonlimab Combination vs Other Treatments for Colorectal Cancer

    This here clinical trial is aimin’ to take a good look at a new combination treatment called co-formulated pembrolizumab/quavonlimab for folks with stage IV colorectal cancer that’s got that microsatellite instability-high or mismatch repair deficient business goin’ on. The main goal is to see how well this new combo treatment works at shrinkin’ them tumors, compared to some other treatments out there.

    Now, the real important part is that the doctors’ll be keepin’ a close eye on how many folks get what they call an objective response, meanin’ their tumors either disappear completely or shrink down by at least 30%. They’ll be trackin’ this over a span of up to around 50 months to get a good picture of how effective this new treatment is.

    Safety’s always a top priority too, so the doctors’ll be watchin’ out for any side effects or issues that might crop up with this new combo treatment. It’s all about findin’ the best way to fight that cancer while keepin’ folks as comfortable as possible.

  • A study comparing biosimilar nivolumab and nivolumab in the treatment of resected melanoma

    The aim of this study is to test whether a new drug called ABP 206 (biosimilar nivolumab) works as well as the approved cancer drug OPDIVO® (nivolumab) in people with advanced cutaneous melanoma that has been surgically removed. The study divided people into 3 groups: one group will receive ABP 206, the second will receive real OPDIVO® approved in the US, and the third will receive the version of OPDIVO® approved in Europe. All of these medicines will be given through an intravenous drip every 4 weeks for up to 1 year, or until the cancer comes back or gets significantly worse.

    The main goal is to check whether ABP 206 (biosimilar nivolumab) is absorbed and maintained in the body in the same way as OPDIVO®. Researchers will also closely monitor how well it works, what the side effects are, and whether the body produces antibodies against it. The entire study will last approximately 13 months for each person joining.

    • Nivolumab biosimilar
    • Nivolumab
  • Study on combining two drugs – Fianlimab and Cemiplimab in patients with previously untreated melanoma

    This study examines two drugs, fianlimab and cemiplimab, given together for the treatment of melanoma. The main goal is to see how effective this drug combination is in treating melanoma compared with pembrolizumab, which is already approved for the treatment of melanoma in adults. The study will also look at whether there are any differences in the effects of these experimental drugs in adolescents and adults.

    Scientists also want to learn about other key issues: what side effects may occur from taking these experimental drugs, how much of the drugs enter the bloodstream over time, and whether the body produces antibodies to the drugs that could make them less effective or cause side effects. They will also check whether taking medications improves patients’ quality of life. Fianlimab and cemiplimab will be administered by intravenous infusion, and pembrolizumab will be administered by intravenous infusion.

    • placebo
    • Fianlimab
    • Cemiplimab
    • Pembrolizumab
  • Study Comparing Asciminib and Nilotinib for Newly Diagnosed Chronic Myeloid Leukemia

    This study examines the effects and tolerance of two drugs, asciminib and nilotinib, for treating a specific type of leukemia called Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in its chronic phase. The participants are adults who have been newly diagnosed and have not received previous treatment for this condition. They will be randomly assigned to receive either asciminib or nilotinib. The study aims to see which drug is better tolerated and how effective they are. Throughout the study, participants will be monitored for any side effects and the progress of their treatment until they either experience significant side effects, the disease progresses, or they decide to stop the treatment. Follow-up checks will also be conducted after the treatment ends.

    • Asciminib
    • Nilotinib
  • Study of Selinexor Combined with Ruxolitinib for Myelofibrosis

    This here clinical trial is studying a new combination of drugs for treating myelofibrosis, which is a type of blood cancer. The main drugs being tested are selinexor and ruxolitinib. Selinexor is a new experimental drug that works by blocking the export of certain proteins from the cell nucleus, while ruxolitinib is an approved drug that inhibits JAK enzymes involved in myelofibrosis.

    The trial has two phases. The first phase, which is already completed, looked at finding the safest and most effective doses of selinexor when combined with ruxolitinib. The second phase is where they are actually testing this drug combination in patients with myelofibrosis who have not received any prior JAK inhibitor treatment.

    Patients in this phase will be randomly assigned to receive either the selinexor + ruxolitinib combination, or a placebo plus ruxolitinib alone. The main goals are to see if the combination can reduce spleen size by at least 35% after 24 weeks of treatment, and also improve symptoms like fatigue, itching, and abdominal discomfort by at least 50% on a special myelofibrosis symptom scale. Safety will also be closely monitored throughout the study.

    • Selinexor
    • Ruxolitinib
  • A study comparing upadacitinib versus adalimumab in the treatment of rheumatoid arthritis

    This clinical trial is studying a new medication called upadacitinib for treating moderate to severe rheumatoid arthritis. Rheumatoid arthritis is a chronic condition that causes pain, stiffness, swelling, and loss of joint function. The study will compare upadacitinib, which is taken as an oral tablet once daily, to adalimumab (brand name Humira), which is an injection given under the skin every other week.

    The main goal is to see how effective upadacitinib is at reducing disease activity compared to adalimumab. The study will measure the percentage of participants who achieve a certain level of low disease activity based on a score called the DAS28-CRP, which looks at tender and swollen joints, overall disease activity, and inflammation levels.

    This is a double-blind study, meaning neither the participants nor the study doctors will know which treatment each participant is receiving. Participants will attend regular visits at a hospital or clinic for medical assessments, checking for side effects, and completing questionnaires. There may be a higher treatment burden compared to standard care. The study is designed to assess the safety and effectiveness of upadacitinib compared to adalimumab in treating moderate to severe rheumatoid arthritis.

    • Adalimumab
    • Upadacitinib
  • A study of relacorilant in the treatment of hypercortisolism (Cushing’s syndrome) in patients with adrenal adenoma

    This clinical trial focuses on testing the effectiveness and safety of a drug called relacorilant in the treatment of patients with hypercortisolism (Cushing’s syndrome). Hypercortisolism is a condition in which there is too much cortisol in the body, which may occur due to an adenoma or hyperplasia of the adrenal glands that secrete cortisol. This condition can lead to diabetes or impaired glucose tolerance and/or uncontrolled high blood pressure.

    The study is in phase III, which means that the effectiveness and safety of the drug are compared with placebo. This is a double-blind, placebo-controlled study, which means neither participants nor researchers know who is receiving the actual drug and who is receiving the placebo to ensure unbiased results.

    Participants in this study will be randomly assigned to receive relacorilant or placebo for 22 weeks. The main goals of the study are to see how well relakorilant can improve blood sugar levels in patients with diabetes or impaired glucose tolerance, and how it affects blood pressure in people with high blood pressure. Additionally, the study will monitor the safety of relacorilant by recording any adverse events that occur.

    People who complete the study may have the opportunity to continue with a follow-up study, which may provide further information on the long-term effects and benefits of relacorilant.

    • Relacorilant
  • Evaluating SPI-62 in treating ACTH-dependent Cushing’s Syndrome

    This is a study focused on a new treatment option for people suffering from ACTH-dependent Cushing’s syndrome, a condition often caused by a non-adrenal tumor. This condition leads to an overproduction of cortisol, which can have a significant impact on health. The study will test the efficacy and safety of a drug called SPI-62, which is designed to inhibit a specific enzyme involved in cortisol production.

    The study is structured as a randomized, placebo-controlled trial, meaning that participants will be randomly assigned to receive either SPI-62 or placebo treatment for a period of 24 weeks. Such a design helps ensure the reliability of the study’s results. Importantly, after this initial period, participants will have the option to continue the study and receive the active study drug, with follow-up visits every three months. The main goal of the study is to observe the change from baseline in urinary HSD-1 ratio, a marker that helps understand the activity of the enzyme targeted by SPI-62 in the liver. Participation in this study includes a screening period, a baseline period and a treatment period, with the possibility of a long-term extension for those who choose to continue.

    This trial represents a hopeful step forward for those affected by ACTH-dependent Cushing’s syndrome, offering a potential new treatment option that targets the condition at a molecular level.

    • SPI-62
  • SPI-62 as new drug for patients with ACTH-dependent Cushing’s syndrome

    This is a study focused on a new treatment option, SPI-62, for people struggling with ACTH-independent Cushing’s Syndrome. The main aim is to evaluate the efficacy and safety of SPI-62 in treating the condition.

    SPI-62 is a drug that works by inhibiting a specific enzyme in the body, potentially reducing excessive cortisol levels that contribute to the disease. During this study, participants will receive SPI-62 in oral tablet form. Dosing will vary, starting at a lower dose and potentially increasing depending on patient response and study requirements.

    The study has been designed as a Phase 2 trial, meaning that the primary focus is on understanding how well SPI-62 can treat the symptoms of hypercortisolism and what its safety profile is. Participants will be in the study for an extended period of time, with scheduled visits at baseline and then at 1, 3, 6, 9 and 12 months, followed by quarterly visits. These visits are crucial to monitor health status and treatment impact.

    One of the key aspects the researchers will be looking at is the change in HbA1c levels, a marker of blood sugar control, after both 6 and 12 weeks of treatment. This will help to understand whether SPI-62 can improve diabetes or the impaired glucose tolerance that often accompanies diabetes.

    • SPI-62- new potential medication for Cushing’s syndrome and Autonomous Cortisol Secretion
  • Stomach cancer treatment comparison: trastuzumab deruxtecan vs. ramucirumab & paclitaxel

    This is a thorough comparison study to measure the effectiveness and safety of two treatment paths. It’s designed for individuals who have experienced progression regarding a stomach (gastric) cancer, or cancer of the gastro-esophageal junction (GEJ). The study focuses on those with HER2-positive gastric or GEJ who have previously undergone a trastuzumab-containing regime but have not received further systemic therapy.The research compares the use of trastuzumab deruxtecan, a potent anti-cancer agent, and the combined use of ramucirumab and paclitaxel. The study’s primary goal is to evaluate the overall survival rate, while secondary aims involve examining progression-free survival, response duration, disease control, safety, pharmacokinetics, and immunogenicity.In the study, participants are fairly and randomly assigned to receive one of two treatments. This is crucial in understanding the superiority and safety of these treatment paths, and this knowledge may inform future approaches to treating these types of cancer.

    • Ramucirumab
    • Trastuzumab deruxtecan
    • Paclitaxel
  • Exploring the safety of seladelpar in treating primary biliary cholangitis

    This is a long-term study on a drug named seladelpar for people with a liver disease called Primary Biliary Cholangitis (PBC). The main goal is to see if this drug is safe and easy for patients with PBC to use over a long period. A secondary goal is to see if seladelpar can effectively treat PBC and improve the patient’s quality of life. The study will track a few things, like if there are changes in the patient’s liver health which may lead to hospitalization or if the patient’s liver enzymes like alkaline phosphate and bilirubin level normalize or not after taking this drug.

    • Seladelpar
  • Ceralasertib & durvalumab vs docetaxel in advanced lung cancer study

    This is an open-label study titled LATIFY, which means everyone will know the type of treatment they are receiving. The study team is looking into a specific type of lung cancer, called Non-Small Cell Lung Cancer (NSCLC) which did not get better after previous treatments. Two treatments will be tested, a new combination of ceralasertib plus durvalumab, compared to a commonly used treatment, docetaxel. Doctors will track participants’ health over time to see which treatment helps people live longer. Understanding the results will help doctors responsibly give the best treatment for patients with this type of lung cancer.

    • Ceralasertib
    • Durvalumab
    • Docetaxel
  • A comprehensive evaluation of retatrutide in obesity and associated comorbidities

    This study evaluates the effectiveness and safety of a new drug, retatrutide, in individuals with obesity or overweight, including those with knee osteoarthritis or obstructive sleep apnea. Lasting about 89 weeks, the trial involves randomized assignment of participants to either receive retatrutide or a placebo. The main goals are to observe changes in body weight, knee pain in osteoarthritis, and sleep apnea severity. The study also examines various secondary outcomes like changes in BMI, waist circumference, and blood pressure. The trial aims to provide new insights into weight management and associated health conditions, offering hope for improved treatments.

    • Retatrutide
  • Examining repotrectinib vs crizotinib in advanced lung cancer treatment

    This trial is named TRIDENT-3, it’s for people who have a particular type of lung cancer that has spread beyond the lungs (advanced or metastatic). The lung cancer for this study is called ‘Non-Small Cell Lung Cancer’ (NSCLC) and it’s positive for an important part of the cells called ‘ROS1.’ The trial will compare two medicines: repotrectinib and crizotinib. People participating in the trial have not been treated with a group of drugs called ‘Tyrosine Kinase Inhibitors’ (TKIs) before. The main goal of this study is to see how effective and safe these two drugs are for these patients.

    • Repotrectinib
    • Crizotinib
  • Exploring the effects and safety of new therapy for Symptomatic Knee Osteoarthritis

    This study is a test of a medication called DFV890, focusing on its effectiveness, safety, and tolerance among individuals with arthritis in their knee, which causes significant pain. Some participants receive the actual medication, while others receive a ‘placebo’ with no active substance. Importantly, neither the participants nor their doctors are aware of which treatment they are receiving. The study duration is slightly over 5 months, and the primary objective is to assess whether DFV890 can help reduce knee pain.

    • DFV890- new potential medication for COVID-19 and knee osteoarthritis
  • Study of the effectiveness of tanimilast in the treatment of pulmonary diseases

    A 52-week clinical trial is being conducted to investigate the effectiveness and safety of the new drug, known as Tanimilast (CHF6001), in people diagnosed with chronic bronchitis and chronic obstructive pulmonary disease (COPD). The primary aim of the study is to determine the effectiveness of CHF6001 administered as an addition to a standard COPD treatment regimen. Study participants will be randomly assigned to receive the study drug CHF6001 or a placebo, which will be taken concurrently with their existing COPD therapy. Key measurements in the study include monitoring the frequency and severity of COPD exacerbations, which are episodes of significantly worsening symptoms. Additionally, the study will assess changes in participants’ lung function and overall quality of life. Typically eligible for the study are adults who are 40 years of age or older, have a documented history of COPD and chronic bronchitis, and are current or former smokers. In particular, the study is of interest to people who have experienced at least one COPD exacerbation in the year preceding the study.

    • Tanimilast/CHF6001
    • Roflumilast
  • Osimertinib effectiveness study for early-stage lung cancer post-surgery

    This study is examining the effects of osimertinib on patients with a specific type of early-stage lung cancer (EGFRm stage IA2-IA3 non-small cell lung cancer) after complete tumor removal surgery. It’s a Phase III trial comparing osimertinib, a new drug, with a placebo. Participants, who have already had surgery for their lung cancer, will either receive osimertinib or a placebo daily for three years. The goal is to see if osimertinib can prevent cancer from coming back and improve patients’ survival rates.

    • Osimertinib
  • Comparing sotorasib and pembrolizumab in treating advanced nonsquamous non-small cell lung cancer

    This trial is testing two first-line therapies in people with advanced lung cancer. Two drugs, Sotorasib and Pembrolizumab, are compared, each combined with a special type of chemotherapy known as a “platinum doublet.” The goal is to determine which combination of these two treatments works most effectively in slowing the growth of the cancer or extending the patient’s life. Patients are selected based on the type and stage of lung cancer. The trial is considered appropriate for people with advanced stage IIIB, IIIC or IV non-squamous non-small cell lung cancer. Additionally, the test is intended for people whose cancer cells show a specific response, including no response to PD-L1, but a positive response to KRAS p. G12C.

    • Sotorasib
    • Pembrolizumab
  • Study of trastuzumab deruxtecan in gastric cancer or gastroesophageal junction adenocarcinoma

    The aim of the DESTINY-Gastric04 study is to help cancer patients suffering from certain diseases. These patients have a specific type of stomach cancer or adenocarcinoma of the gastroesophageal junction that has not responded to treatment or has gotten worse after treatment with a medicine called trastuzumab. This study is testing a new drug called trastuzumab deruxtecan, comparing it with a combination of two other drugs – ramucirumab and paclitaxel. A key goal of this study is to determine how long participants will live after starting a new treatment. It will also be observed whether the cancer will shrink or stop growing, how long it will last, what the potential side effects of treatment will be and how the body will respond to the new drug.

    • Ramucirumab
    • Trastuzumab deruxtecan
    • Paclitaxel