There are about 21071 clinical studies being (or have been) conducted in Spain. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: - To compare the overall survival in both treatment arms. - To evaluate the objective response rate in both treatment arms. - To evaluate the duration of response in both treatment arms. - To evaluate the clinical benefit rate in both treatment arms. - To evaluate progression-free survival on next line of therapy. - To evaluate the pharmacokinetics of amcenestrant, and palbociclib. - To evaluate health-related quality of life in both treatment arms. - To evaluate the time to first chemotherapy in both treatment arms. - To evaluate safety in both treatment arms.
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmaco-dynamics and preliminary anti-tumor activity of DRP-104 (sirpiglenastat) administered via intravenous infusion or via subcutaneous injection as a single agent and in combination with atezolizumab in patients with advanced solid tumors and to assess preliminary safety and efficacy of which route of administration (intravenous or subcutaneous) will be selected for further development for the one expansion of patients, advanced non-small cell lung cancer (NSCLC) with defined genetic mutations.
The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope prosthesis (hereafter WA-NG telescope), an injectable telescope device, in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.
The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be determined by a Next Generation Sequencing (NGS) test.
HR+/HER2-negative BC represent ∼70% of all newly diagnosed breast tumours and are responsible for most recurrences and deaths due to this disease, and despite available standard therapies, ∼15-20% of hormone tumours recur at distant sites. As BC is a clinically and biologically heterogeneous disease, intrincsic subtype may play an important role in classifying patients. In this case, HER2-E subtype is present in approximately 6.6-11.0% of HR+/HER2-negative tumors and might express either HER2, estrogen receptor (ER) or progesterone receptor (PR), we also know that HER2-E is present twice as much in metastatic tumors compared to primary tumors and that HER2-E patients may benefit in terms of PFS form an anti-HER2 drug as was showed using retrospective sample in EGF30008 trial. Therefore, incorporation of novel drugs in combination with endocrine therapy (ET) can improve patient outcomes in HR+/HER2-negative BC advanced disease specially in those with HER2-E subtype. Methods NEREA is an open-label, single arm, multicenter phase II study evaluating treatment with neratinib in combination with ET in pre and post-menopausal women and men with locally advanced or metastatic HER2-enriched (HER2-E), HR+/HER2-negative breast cancer who had recurrence or progression while receiving previous ET (either aromatase inhibitors, tamoxifen or fulvestrant) in the adjuvant setting or to treat advanced disease or both. The study will follow a Simon's 2-stage design with one interim and one final efficacy analysis. The primary objective will is assess the efficacy of neratinib in combination with ET is this group of patients, efficacy will be measured as Progression-Free Survival at 6 months (PFS6) defined as the proportion of patients alive and without progression, locally assessed by the investigator through the use of RECIST v.1.1 at 24 weeks after first treatment administration, imaging evaluation will be performed every 8 weeks for the first 12 months following treatment start, and every 12 weeks thereafter. Secondary endpoints include Clinical Benefit Rate at 6 months , Overall Response rate, Duration of response, Time to response and Incidence, duration and severity of Adverse Events. The interim analysis will be conducted when 33 patients are evaluable for the primary endpoint having the potential for at least 3 'on treatment' disease assessment scans. If less than 15 patients achieved a PFS6, the trial will be terminated for futility in favor of the null hypothesis. If more than 28 patients achieved a PFS6, the trial will be stopped in favor of the alternative hypothesis demonstrating activity. If none of the two above-mentioned conditions are attain, up to a further 23 patients may be evaluated, for at least a total of 56 evaluable patients. Therefore, if a total of 28 or more patients achieved a PFS6 at the end of the second stage, then the null will be rejected in favor of the alternative. Eligible patients will receive neratinib 240 mg every day in combination with ET, with either exemestane, fulvestrant or tamoxifen: exemestane 25 mg every day orally, tamoxifen 20mg every day orally or fulvestrant 500 mg administered in two intramuscular injections of 250 mg each at C1D15 and at D1 of each subsequent 28-day cycle at investigator discretion. LHRH agonist will be used in men and premenopausal women if no oophorectomy has been performed previously. All patients will take prophylactic loperamide with a stablished doses scheme during the firs cycle and on demand in subsequent cycles
An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline on their current GC regimen. Optional open label treatment extension period up to 240 weeks with 200mg Tildacerfont QD.
This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).
This is a first-in-human, open-label, multi-center, Phase 1/2, dose-escalation study with expansion cohorts to evaluate NM21-1480 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.
This is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19).
This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.