Petah Tiqva, Israel

  • Featured

    Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

    Phase

    2

    Span

    279 weeks

    Sponsor

    Incyte Corporation

    Milano

    Recruiting

  • Featured

    Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

    The purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib to participants who are currently enrolled in an Incyte-sponsored study and receiving the same treatment, who have at least stable disease, who are obtaining clinical benefit (in the opinion of the investigator) on the current study treatment, as defined by the parent Protocol, and who are unable to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib outside a clinical study. Participants will continue on the same dose and schedule as the ones being administered in the Incyte- sponsored parent Protocol at the time of the rollover. The study will collect and assess safety information with regards to AEs.

    Phase

    2

    Span

    217 weeks

    Sponsor

    Incyte Corporation

    Milano

    Recruiting

  • Featured

    A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)

    For more information, please contact Incyte Corporation at 1.855.463.3463 or visit **[www.incyteclinicaltrials.com](https://www.incyteclinicaltrials.com/)**

    Phase

    3

    Span

    Sponsor

    Milano

    Recruiting

  • Featured

    A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

    * Interventional Study * Estimated Enrollment:170 participants * Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations. * This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. * There is no difference in the treatment regimen between the cohorts.

    Phase

    2

    Span

    Sponsor

    Milano

    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

    Milano, Milan

    Recruiting

  • Featured

    A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia

    This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study. Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study. Subjects will continue with their usual levodopa treatment regimen for the duration of study participation. The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2 placebos as per the double-dummy study design. The randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (PK) sub-study.

    Phase

    2

    Span

    231 weeks

    Sponsor

    Contera Pharma

    Via Francesco Sforza, Milano

    Recruiting

  • The Caton-Deschamps Index Reliability in Patellar Stabilization Surgery.

    The patellofemoral joint (PFJ) consists of two bony components, the patella and the femoral trochlea, sharing the same joint surface (1). It may be prone to instability, that is when the patella dislocates, usually on the lateral side of the knee. The incidence of primary patellar dislocation has been reported to be 5.8 cases per 100,000 in the general population, with the highest incidence occurring in the 2nd decade of life (29 per 100,000) (2). Patellar instability can be classified as traumatic, when the dislocation is caused by an external force, or nontraumatic, when native anatomy of the knee predisposes to instability. Non-operative treatment is usually taken into account for first episode of lateral patellar dislocation, unless the presence of loose bodies is verified, and consists of knee immobilization, physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs) administration (3). Recurrence rate after conservative management can be up to 15-44% and patients with a clinical history of two or more dislocations have a 50% chance of recurrent dislocation episodes (4). Recurrent instability is a multifactorial problem that rely on limb alignment, bone anatomy of the patella and the trochlear groove, soft-tissue constraints, especially the medial patello-femoral ligament (MPFL). The management of recurrent patellar instability is difficult for many reasons, including heterogeneous patient population, skeletal maturity, challenging surgical approach and lack of long-term and robust clinical outcome studies (5,6). Radiologic evaluation should study the three principal factors of instability: trochlear dysplasia, abnormal patellar height, pathological tibial tubercle-trochlear groove (TT-TG) distance (7). Patellar height can be easily assessed, through standard lateral view radiographs. Several indexes for studying and calculating patellar height have been described in the literature (8-10). In patellar instability, the use of Caton-Deschamps index CDI to measure patellar height one of the most employed. Specifically, CDI relies upon the length of the articular surface of the patella and its distance from the tibia. The purpose of our study is to evaluate the reliability and reproducibility of CDI in measuring patellar height for planning patella stabilization surgery. The secondary target is to hypothesize a quantitative method of preoperative planning for anterior tibial apophysis transposition surgery, by calculating CDI.

    Phase

    N/A

    Span

    12 weeks

    Sponsor

    Istituto Ortopedico Galeazzi

    Milan

    Recruiting

  • HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting

    Study Objective: This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors. Study Design: This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason. Study Duration: The overall study duration is 24 months, with recruitment lasting 20 months, data extraction and review taking 2 months, statistical analysis requiring 1 month, and result writing taking 1 month. Study Procedure: Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization. Additional Procedures or Analyses: - Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside. - In case of a positive rapid capillary HIV test result, antigen/antibody testing (using Cobas 6800®) and Western Blot for HIV confirmation will be performed on venous blood samples on the same day at the San Raffaele Hospital virology laboratory in Milan. - If HIV infection is confirmed, an infectious disease specialist will assess the patient within 48 hours of diagnosis and request viral load determination (HIV-RNA), CD4+ lymphocyte count. The individual will also be directed to follow-up care at the Infectious Diseases Unit of San Raffaele Hospital, with subsequent linkage to care and start of antiretroviral therapy (ART), according to clinical practice. - If the capillary HIV test result is negative, the patient will be informed of the negative result.

    Phase

    N/A

    Span

    107 weeks

    Sponsor

    Castagna Antonella

    Milan

    Recruiting

    Healthy Volunteers

  • Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery

    Neoadjuvant chemotherapy (NACT) in breast cancer is considered the "gold standard" for the treatment of locally advanced and inoperable malignancies. In recent years, in view of the evidence gathered, it has also become a conventional treatment alternative for patients with operable disease who are possible candidates for adjuvant chemotherapy. NACT thus aims to reduce mortality and increase surgical options, while at the same time allowing in vivo chemosensitivity testing. In view of this, NACT represents the ideal setting for clinical and translational research, which nowadays also has to address the question of future treatment options. It is indeed a source of lively debate whether chemotherapy should be considered the only possible treatment option for the patient. This study falls into this context, the innovative aim of which is to demonstrate histologically with the use of VABB, the complete pathological response (pCR) and to avoid surgery. The main aim of this study is to show that a non-surgical, radiotherapy-only treatment and follow-up approach is not inferior to a surgical approach for patients who have shown complete pathological response (pCR) following neoadjuvant chemotherapy (NACT), as confirmed through histological analysis of imaging-guided sampling. Histology will be performed by sampling 4 grams of tissue by vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) by ultrasound guidance (on breast marker). The hypothesis of the study is that the VAE/VABB will be used in patients with pCR at post-NACT imaging to demonstrate the absence of disease in the previous tumour bed and, accordingly, that the use of VAE/VABB with negative histology would lead to a gold standard of treatment without surgical overtreatment.

    Phase

    N/A

    Span

    264 weeks

    Sponsor

    European Institute of Oncology

    Milan

    Recruiting

  • Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease

    Aims of the study: 1. Evaluate the diagnostic accuracy of MRI with the collection of more specific sequences for the inner ear (3D-FLAIR) in identifying intralabyrinthine anomalies in patients with Ménière's disease or acute/subacute sudden hearing loss and not only the retrochlear pathology/neurological causes . 2. Characterize the vascular and inflammatory MRI patterns 3. Define the prognostic role of MRI with pre- and post-contrast 3D-FLAIR sequence, eliminating confounding factors such as MRI execution time, the methodology used, the effect of previous therapy and the criteria for defining improvement. 4. Correlate 4-hour 3D-FLAIR MRI imaging data with clinical and hematological data

    Phase

    N/A

    Span

    394 weeks

    Sponsor

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    Milan

    Recruiting

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