Etude de phase IV, randomisée en double insu, double placebo sur deux groupes parallèles : KETUM® 2.5% gel versus diclofénac 50 mg per os dans l’arthrose symptomatique de la main.

Start Date22 Jan 2007

Sponsor / Collaborator

Laboratorios Menarini SA

EUCTR2004-001373-26-ES / Not yet recruitingPhase 4

Multicentre clinical trial to evaluate the efficacy and safety of dexketoprofen trometamol (50 mg t.i.d.) versus ketorolac (30 mg t.i.d.) and placebo by intravenous route, as part of balanced analgesic therapy with morphine, followed by an oral dosing, in the treatment of postoperative pain

Start Date15 Nov 2004

Sponsor / Collaborator

Laboratorios Menarini SA

100 Clinical Results associated with Laboratorios Menarini SA

0 Patents (Medical) associated with Laboratorios Menarini SA

Literatures (Medical) associated with Laboratorios Menarini SA

05 Nov 2021·Blood

The First Real-World Evidence Prospective Registry of Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm Treated with Tagraxofusp, a CD123-Targeted Therapy, in Europe

Author: Platzbecker, Uwe ; Mughal, Tariq I. ; Casariego, Joaquín ; Montesinos, Pau ; Lemoni, Roberto M. ; Angelucci, Emanuele ; Spyridonidis, Alexandros ; Mohty, Mohamad

AbstractBackgroundBlastic plasmacytoid dendritic cell neoplasm (BPDCN) is an extremely rare hematologic malignancy affecting 1.5-2.0 per million adults per year worldwide, which corresponds to approximately 1,000 cases in Europe. It is a highly aggressive disease characterized by skin and bone marrow involvement, with secondary sites including lymph nodes and viscera. BPDCN is associated with a poor prognosis, median overall survival of 8-14 months, and has no firm consensus for therapy. Tagraxofusp (TAG, SL-401) is currently the only approved first-line treatment for adult patients with BPDCN in Europe. TAG is a targeted therapy directed to CD123 that has shown efficacy in a controlled, prospective trial with prespecified endpoints. Specifically, TAG is a recombinant cytotoxin composed of human interleukin-3 fused to a truncated diphtheria toxin payload that targets CD123, the α-subunit of interleukin-3 receptor commonly overexpressed on the surface of BPDCN tumor cells. In the past, most adult and pediatric patients in Europe were treated with a plethora of experimental combination chemotherapies often imported from aggressive myeloid and lymphoid malignancy treatment regimens, followed by hematopoietic stem cell transplantation (SCT), as best available treatment. However, there is no robust evidence of the effectiveness and safety of these therapies for BPDCN, due to its rarity, the absence of prospective studies, and the variability in diagnostic criteria, definition of endpoints, and assessment of outcomes. As of July 2021, 65 patients with BPDCN have been treated with TAG in a clinical setting outside the US, as part of an expanded access program. Continued collection of clinical data from the use of TAG in a real-world setting in patients with BPDCN is important to increase the knowledge of clinical outcomes, especially in patient populations commonly underrepresented in clinical trials. This is the first real-world evidence prospective registry in patients with BPDCN receiving TAG. The study is designed to meet the requirements included in the marketing authorization by the European Commission, to further investigate the effectiveness and safety of TAG in the treatment of patients with first-line or relapsed/refractory BPDCN.Study Design and MethodsThis is a noninterventional, single-arm study (EudraCT: 2021-001684-24) in patients with BPDCN to assess clinical effectiveness and safety of TAG under real-world routine clinical practice conditions (12 mcg/kg intravenously [IV] once daily on days 1-5 of a 21-day cycle, per the summary of product characteristics general recommendation). Up to 125 patients are planned for inclusion in approximately 65 clinical sites in Europe estimated over 3 years. Eligible patients have a diagnosis of BPDCN and are scheduled to start TAG monotherapy, per physician's decision.The primary study objectives are to determine the complete response (CR) rate, defined as CR + clinical CR (CR with residual skin abnormality not indicative of active disease) after 3 months of treatment, and to assess the safety of TAG, in particular the incidence and severity of capillary leak syndrome (CLS). Secondary objectives include analysis of the rate of patients bridging to SCT, progression-free survival, overall survival, best overall response, duration of response, dose interruptions/administration of IV albumin supplementation in patients with CLS or CLS symptoms, incidence and severity of adverse events of special interest (AESIs), overall safety, and TAG treatment administered. AESIs include CLS and hepatic, renal, and cardiac events.Per routine clinical practice, quarterly data collection is anticipated during the study. In addition, data will be collected at screening, enrollment, early discontinuation, and study end (Figure). The end of the registry safety data collection will be 18 months after the last enrolled patient's first visit (LPFV). Interim analyses will be performed annually, and an effectiveness interim analysis is scheduled at 12 months post-LPFV. All effectiveness and safety analyses will be performed using descriptive statistics. Survival data will be summarized using the Kaplan-Meier method. Subgroup analyses for effectiveness and safety may be performed, on the basis of gender, age, or Eastern Cooperative Oncology Group performance status at baseline.Enrollment is planned to start by December 2021.Figure 1 Figure 1.DisclosuresPlatzbecker: Celgene/BMS: Honoraria; Novartis: Honoraria; Janssen: Honoraria; Takeda: Honoraria; AbbVie: Honoraria; Geron: Honoraria. Angelucci: Menarini-Stemline: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: steering commitee, Speakers Bureau; Vertex Pharmaceuticals: Honoraria, Other: DMC; Celgene BSM: Honoraria, Other: DMC; Blue Bird Bio: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Crispr therapeutics: Honoraria, Other: DMC; Glaxo: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees. Montesinos: Glycomimetics: Consultancy; Teva: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Sanofi: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Tolero Pharmaceutical: Consultancy; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Forma Therapeutics: Consultancy; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Daiichi Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Karyopharm: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Agios: Consultancy; AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Astellas Pharma, Inc.: Consultancy, Honoraria, Other: Advisory board, Research Funding, Speakers Bureau; Stemline/Menarini: Consultancy. Lemoni: AbbVie: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Jazz: Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees; Servier: Membership on an entity's Board of Directors or advisory committees; Stemline Therapeutics: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding. Spyridonidis: Menarini: Current Employment. Casariego: Menarini: Current Employment. Mughal: Stemline: Current Employment, Current holder of stock options in a privately-held company; Oxford University Press, Informa: Other: financial benefit and/or patents . Mohty: Sanofi: Honoraria, Research Funding; Pfizer: Honoraria; Novartis: Honoraria; Takeda: Honoraria; Jazz: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Gilead: Honoraria; Celgene: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria; Astellas: Honoraria; Amgen: Honoraria; Adaptive Biotechnologies: Honoraria.

01 May 2021·International Journal of PharmaceuticsQ2 · MEDICINE

Spectrophotometry and pharmaceutical PAT/RTRT: Practical challenges and regulatory landscape from development to product lifecycle

Q2 · MEDICINE

Article

Author: Sabatini, Cristina ; Spagnoli, Chiara ; Ricci, Maurizio ; Calamassi, Niccolò ; Minghetti, Paola ; Panzitta, Michele ; Venturini, Andrea ; Bruno, Giorgio ; Vizzini, Vittoria ; Grassi, Marzia ; Pontello, Lino ; Ricchiuto, Elisa ; Brogi, Andrea ; Brassier Font, Judit

European Pharmacopoeia includes dedicated chapters for Raman, NIR and Chemometrics, as well as there is a lot of Academia research on the matter. Despite that, the word innovation is often associated to such tools and there is a still slow implementation at industry. The paper is the outcome of the Associazione Farmaceutici dell'Industria (AFI) Study Group on Process Innovation and Product Lifecycle; the aim is to describe some case studies referring to practical approaches in pharmaceutical industry, in order to depict challenges and opportunities for the implementation of spectroscopic techniques. Case studies include: feasibility and pre-screening evaluations, chemometric model development approaches, way for the method maintenance during commercial manufacturing, challenges for implementation on existing equipment and on sterile processes. Case studies refer to oral solid products, liquid products and sterile Active Pharmaceutical Ingradient (API) manufacturing. There are already successful and robust spectroscopic applications in pharmaceutical industry and the technology is mature: this is the outcome of a strong applied research performed at pharmaceutical production departments. It is necessary to acknowledge efforts done by industry as Research for strengthening the cooperation with Academia, so that advantage of process innovation might reach the patients in a fastest way.

01 Sep 2007·NIR news

Non-Destructive Dissolution Testing by NIR Spectroscopy

Author: González, Josep M. ; Torras, Ester ; Alcalá, Manel ; Blanco, Marcelo

manufacturing process, the dissolution time increasing with increasing compaction. Near infrared spectroscopy has been used in different ways to determine dissolution-related parameters. Methods allowing the rapid extraction of information about the dissolution profi le of a substance can be highly useful in the effi cient control of production processes, by adjusting the operation of the tablet pressing machine to the requirements established in the manufacturing protocol. Such methods can therefore be highly practical and effi cient process analytical technology (PAT) tools. In this work, we used NIR spectroscopy to determine the entire dissolution profi le of pharmaceutical tablets that were analysed on an individual basis, by using a single PLS2 calibration model which allowed the simultaneous prediction of the whole set of variables Y (viz. the percentages of API dissolved throughout the dissolution profi le). Also PLS1 models are presented for the determination of the percentage of API in solution at a fi xed time.

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100 Translational Medicine associated with Laboratorios Menarini SA

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