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A PHASE IIIB, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) IN COMBINATION WITH BEVACIZUMAB TO INVESTIGATE SAFETY AND EFFICACY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA NOT PREVIOUSLY TREATED WITH SYSTEMIC THERAPY - AMETHISTA - AMETHISTA

开始日期2020-07-16

申办/合作机构

Roche SpA

EUCTR2019-001146-17-IT / Not yet recruiting临床3期

A PHASE IIIB, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) IN COMBINATION WITH CARBOPLATIN PLUS ETOPOSIDE TO INVESTIGATE SAFETY AND EFFICACY IN PATIENTS WITH UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER - -

开始日期2019-07-16

申办/合作机构

Roche SpA

CTR20191103 / CompletedN/A

维莫非尼治疗中国BRAF V600突变型晚期黑色素瘤患者的非干预性研究

提供维莫非尼在真实世界中治疗BRAFV600突变型中国晚期黑色素瘤患者的有效性和安全性数据。

开始日期2019-06-10

申办/合作机构

Roche Pharma (Schweiz) AG

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100 项与 Roche SpA 相关的临床结果

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0 项与 Roche SpA 相关的专利（医药）

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4

项与 Roche SpA 相关的文献（医药）

2022-01-27·Advances in Hematology

Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study

Article

作者: Inzoli, Alessandro ; Battistini, Roberta ; Gaglione, Gianfranco ; Mannina, Donato ; Cardinale, Giovanni ; Santoro, Armando ; Murineddu, Marco ; Turrini, Mauro ; Fraticelli, Vincenzo ; Corradini, Paolo ; Cantore, Nicola ; Caparrotti, Giuseppe ; Barbiero, Valentina ; Santini, Simone ; Ladetto, Marco ; Mengarelli, Andrea ; Petrini, Mario ; La Nasa, Giorgio ; Martelli, Maurizio ; Gaidano, Gianluca ; Camera, Andrea ; Consoli, Ugo ; Ferreri, Andres J. M. ; Stelitano, Caterina ; Marino, Dario ; Musto, Pellegrino ; Arcaini, Luca ; Guarini, Attilio ; Liberati, Anna Maria ; Ronci, Benedetto ; Cerqueti, Manuela ; Massimi, Stefano ; Ferrando, Paola

Subcutaneous (SC) rituximab may be beneficial in terms of convenience and tolerability, with potentially fewer and less severe administration-related reactions (ARRs) compared to the intravenous (IV) form. This report presents the results of a phase IIIb study conducted in Italy. The study included adult patients with CD20+ DLBCL or FL having received at least one full dose of IV RTX 375 mg/m2 during induction or maintenance. Patients on induction received ≥4 cycles of RTX SC 1400 mg plus standard chemotherapy and FL patients on maintenance received ≥6 cycles of RTX SC. Overall, 159 patients (73 DLBCL, 86 FL) were enrolled: 103 (54 DLBCL, 49 FL) completed induction and 42 patients with FL completed 12 maintenance cycles. ARRs were reported in 10 patients (6.3%), 3 (4.2%) with DLBCL and 7 (8.1%) with FL, all of mild severity, and resolved without dose delay/discontinuation. Treatment-emergent adverse events (TEAEs) and serious adverse events occurred in 41 (25.9%) and 14 patients (8.9%), respectively. Two patients with DLBCL had fatal events: Klebsiella infection (related to rituximab) and septic shock (related to chemotherapy). Neutropenia (14 patients, 8.9%) was the most common treatment-related TEAE. Two patients with DLBCL (2.8%) and 6 with FL (7.0%) discontinued rituximab due to TEAEs. 65.2% and 69.7% of patients with DLBCL and 67.9% and 73.6% of patients with FL had complete response (CR) and CR unconfirmed, respectively. The median time to events (EFS, PFS, and OS) was not estimable due to the low rate of events. At a median follow-up of 29.5 and 47.8 months in patients with DLBCL and FL, respectively, EFS, PFS, and OS were 70.8%, 70.8%, and 80.6% in patients with DLBCL and 77.9%, 77.9%, and 95.3% in patients with FL, respectively. The switch from IV to SC rituximab in patients with DLBCL and FL was associated with low risk of ARRs and satisfactory response in both groups. This trial was registered with NCT01987505.

2014-11-01·Value in Health2区 · 医学

Organizational and Management Impact Analysis of Using the New Subcutaneous Formulation of Tocilizumab in Selected Italian Rheumatology Centers

2区 · 医学

Article

作者: Govoni, M ; Adami, S ; Ciancio, G ; Paolini, D ; Canciani, M ; Tomic, R ; Ravera, S ; Bianchino, L ; Viapiana, O ; Farina, M

Research & Reviews: Journal of Medical and Health Sciences

Nodolase: a review of efficacy

作者: Sarracino, Massimo

NODOLASE it's a new dietary supplement formulated with natural active and characterized by anti-inflammatory, anti-edema, analgesic and anti-oxidant effects.The aim of this review was to report the efficacy of NODOLASE in several patients.NODOLASE has been studied in patients with joint, tendons and muscle diseases, acute exacerbations of COPD and dental disease.In patients with wrist, ankle and knee sprain or with muscle strain as well as after plaster cast removal, NODOLASE resulted in a good efficacy in reducing pain and swelling.Furthermore, NODOLASE was able to significantly improve the joint function by a significant reduction of stiffness of at least 30% in all studies.In patients with mild to moderate acute exacerbations of COPD, NODOLASE has been added to the antibiotic therapy.However, compared to the broad-spectrum antibiotic therapy alone, the combination with NODOLASE has resulted in a faster improvement of cough and dyspnea.The results of this study showed that the antibiotic association with NODOLASE was able to improve better the respiratory function (FEV1) compared to antibiotic monotherapy.Also extremely important the addition of NODOLASE has determined a higher impact on the inflammatory pattern and in particular on IL-6, IL-8 and TNF-alpha in comparison to the antibiotic alone.NODOLASE in combination with analgesic in patients undergoing wisdom teeth has been investigated in a randomized study.In comparison with a traditional analgesic for 7 days the group treated with the combination NODOLASE + analgesic achieved better results in terms of efficacy with a lower incidence of pain local recurrence as well as a better recovery of the mandibular function.No adverse effects due to the administration of NODOLASE were reported.Treatment with NODOLASE was evaluated safe in all studies both by clinicians and patients.

100 项与 Roche SpA 相关的药物交易

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100 项与 Roche SpA 相关的转化医学

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