Glifada, Greece

  • Featured

    Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

    Phase

    2

    Span

    227 weeks

    Sponsor

    Mirati Therapeutics Inc.

    Valencia, Valencia

    Recruiting

  • Featured

    A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy (KRYSTAL-10)

    Phase

    3

    Span

    Sponsor

    Mirati

    Valencia, Valencia

    Recruiting

  • Featured

    A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement

    Phase

    2

    Span

    Sponsor

    Valencia, Valencia

    Recruiting

  • Featured

    A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement

    * All potential subjects must have documentation of an 8p11 translocation known to activate FGFR1 through the site's own cytogenetics laboratory. * Once documentation has been provided, the subject will then undergo screening to meet the rest of the inclusion/exclusion criteria. * Once a subject has completed screening and has enrolled into the study, treatment will start on Cycle 1 Day 1. * Subjects will undergo regular safety assessments during treatment as well as regular efficacy assessments. * Subjects will be allowed to continue administration in 21-day cycles until loss of benefit from therapy or unacceptable toxicity is reported.

    Phase

    2

    Span

    Sponsor

    Valencia, Valencia

    Recruiting

  • Featured

    Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-12)

    Phase

    3

    Span

    Sponsor

    Valencia, Valencia

    Recruiting

  • Keeping RAASi Treatment With Optimal Potassium Control

    Hyperkalemia is a potentially life-threatening condition associated with ventricular arrhythmias and sudden cardiac arrest. It is common in patients with some comorbidities such as chronic kidney disease, congestive heart failure, cardiovascular disease, diabetes or liver disease. Most of these patients should receive drugs that block the renin angiotensin aldosterone system (RAASi) and mineralocorticoid receptor antagonists (MRA), that increase the risk of hyperkalemia. For these reasons, relatively few patients receive maximum doses of RAASi / MRA. The dose and its usage decline following an hyperkalemia episode. However, RAASi / MRA discontinuation because of hyperkalemia, represents an undesirable clinical scenario, loosing their potential cardiorenal and nephroprotective benefit. Patients on submaximum doses or who discontinued RAASi / MRA have worse outcomes than patients on maximum doses. In this study 78 adult patients will be randomized to one of two treatment arms to analyze the proportion of patients achieving sK of < 5.5 mEq/L: - Control group: they will have their treatment with iSRAA and/or ARM withdrawn or tapered, according to standard clinical practice. - Experimental group: treatment with iSRAA and/or ARM will be maintained and oral treatment with CSZ (Lokelma) will be added. The study will be conducted in 3 periods: - Patient selection (Visit 0). - Randomization (Visit 1). - Follow up (Visits 2-7). All the patients randomized and completing the treatment assigned will be participating in the study for an stimated period of 90 ± 13 d. The clinical trial will be finalized when the last 90-day follow-up of the last patient included is performed.

    Phase

    3

    Span

    200 weeks

    Sponsor

    Fundación para la Investigación del Hospital Clínico de Valencia

    Valencia

    Recruiting

  • Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

    This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

    Phase

    3

    Span

    293 weeks

    Sponsor

    Daiichi Sankyo

    Valencia

    Recruiting

  • A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients

    This is a randomized clinical trial, multicentre, parallel group, open label, to evaluate the use of sodium zirconium cyclosilicate (SZC) to optimize RAASi therapy in patients with heart failure and chronic kidney disease, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines (1), without inducing clinically significant hyperkalemia. Eligible subjects will have been admitted to hospital because of an HF (NYHA I- III) decompensation, will have required intravenous diuretics and will have had mild hyperkalaemic values that needed stabilization or be at risk of developing hyperkalaemia. Subjects will be randomised in a 1:1 ratio to receive SZC or none (standard of care treatment without potassium binders) for 3 months while optimizing RAASi therapies according to the European Society of Cardiology (ESC) guidelines.

    Phase

    3

    Span

    78 weeks

    Sponsor

    Fundación para la Investigación del Hospital Clínico de Valencia

    Valencia

    Recruiting

  • Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.

    Anastomotic Leakage (AL) is the complication that most concerns colorectal surgeons. It leads to prolonged postoperative stay, increased costs, risk of reoperations and a permanent colostomy, together with an increase in morbidity and mortality. The novel Echelon Circular™ Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), introduces design changes that could decrease the rate of technical errors and improve clinical outcomes. The powered stapler decreases the force needed on firing the device, improving stability at the anastomotic site. Atraumatic Gripping Surface Technology reduces the compressive forces on tissues, and along with 3D Stapling Technology allows a better compression distribution throughout the anastomosis and a better hemostasis. This is a multicenter, randomized, open-label, controlled with parallel groups clinical trial, with 8 participant sites in total (4 sites in Spain and 4 sites in France), to include an approximate sample size (n) of 570 patients who will undergo a colorectal anastomosis after Hartmann reversal, left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology. 540 patients assigned randomly 1:1 to assess whether technical improvements of Echelon Circular™ Powered Stapler (ECPS) have an impact on left-sided colorectal Anastomotic Leakage (AL) rate compared to current manual circular staplers (MCS). Anastomosis could be performed open, laparoscopically or with robotic assistance. After surgery, patients will be followed during 30 days in order to evaluate the primary endpoint.

    Phase

    N/A

    Span

    114 weeks

    Sponsor

    Fundación para la Investigación del Hospital Clínico de Valencia

    Valencia

    Recruiting

  • A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

    This is open-label, multi-center study to evaluate the safety and preliminary efficacy of AZD0486 administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies. This master study currently includes 3 substudies and each substudy focusing on a defined population: Substudy 1: Relapsed/refractory (R/R) Chronic lymphocytic leukaemia (CLL)/ Small lymphocytic leukaemia (SLL) Substudy 2: R/R Mantle-cell lymphoma (MCL) Substudy 3: Large B-cell lymphoma (LBCL) or R/R B-cell non-Hodgkin lymphoma (B-NHL) (not applicable to US) The study will have the following sequential periods: 1. Screening period of 28 days 2. Treatment period 3. Follow-up period

    Phase

    1/2

    Span

    326 weeks

    Sponsor

    AstraZeneca

    Valencia

    Recruiting

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