An Academic Prospective Single-arm Phase II Clinical Trial for Evaluation of Advanced Functional Neuroimaging Techniques and Molecular Markers in the Course of Anti-angiogenic Therapies in Malignant Gliomas

Malignant glioma are the most common and aggressive primary brain tumors in adults. Despite advances in multimodal treatment including surgery, radiation and chemotherapy, most patients have a dismal prognosis of 9-15 months (Stupp et al., NEJM 2005).
A major reason for the aggressiveness of malignant glioma is a pronounced tumor neovascularization, mainly driven by the vascular endothelial growth factor (VEGF) and its receptors. The therapeutic monoclonal antibody Bevacizumab (Avastin®) inhibits the VEGF pathway by binding the VEGF ligand. In Magnetic Resonance Imaging (MRI) this treatment reduces contrast enhancement by restoring both, the blood-brain-barrier and the destabilized vessel integrity. Furthermore, it raises the sensitivity of co-administered chemotherapeutics such as Irinotecan. In conclusion, anti-angiogenic therapy leads to the problem that the routinely used MRI techniques cannot distinguish anti-vascular effects from true anti-tumor effects.
The study hypothesis of the clinical trial part is that in 35% of malignant glioma patients Avastin / Irinotecan chemotherapy results in objective tumor responses assessed by standard / functional MRI and FET- /FLT-PET neuroimaging. The study hypothesis for the translational study part is that the expression of the molecular targets of Avastin and Irinotecan in malignant glioma tissue ( = tumor and vascular cells) are predictive for Avastin / Irinotecan therapy induced treatment response measured by functional MRI and FET- / FLT-PET imaging.

开始日期2010-03-01

申办/合作机构

Medical University of Innsbruck

[+1]

EUCTR2006-000026-31-AT

/ Not yet recruitingN/A

Bevacizumab as treatment for patients with relapsed/refractory multiple myeloma - Avastin in MM

开始日期2006-06-20

申办/合作机构

Roche Austria GmbH

EUCTR2005-005883-10-AT

/ Not yet recruitingN/A

A phase II study of Bevacizumab with Docetaxel and Capecitabine in the neoadjuvant setting for breast cancer patients

开始日期2006-05-06

申办/合作机构

Roche Austria GmbH

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0 项与 Roche Austria GmbH 相关的专利（医药）

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项与 Roche Austria GmbH 相关的文献（医药）

2025-01-01·DIGITAL HEALTH

Cost-effectiveness of the Floodlight^® MS app in Austria. Unlocking the mystery of costs and outcomes of a digital health application for patients with multiple sclerosis

Article

作者: Guger, Michael ; Traunfellner, Matthäus ; Mikl, Veronika ; Goger, Christoph ; Meyer, Franz ; Walter, Evelyn ; Enzinger, Christian ; Bsteh, Christian ; Altmann, Patrick ; Hegen, Harald

Objective Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease affecting 2.9 million people worldwide, often leading to permanent disability. MS patients frequently use eHealth tools due to their relatively young age. The Floodlight® MS app is a scientifically designed smartphone application that helps patients monitor hand motor skills, walking ability and cognition between medical appointments. This study assesses the cost-effectiveness of using the Floodlight® MS app alongside standard-of-care (SoC) versus SoC alone in patients with relapsing-remitting MS (RRMS) from the perspective of the healthcare system. Methods A 10-year decision-analytic model was developed to assess the cost-effectiveness of incorporating the Floodlight® MS app alongside SoC. The analysis included treatment-naive individuals and those already on drug therapy, modelling the app's role in early detection of disease progression and relapses to improve quality-of-life. Results For treatment-naive patients, using the Floodlight® MS app resulted in a 2,660 € increase in total costs but yielded potential medical-cost savings of 786 € through health improvements. These patients experienced fewer relapses and slower disability progression, translating to a quality-of-life improvement of 4.5 months in perfect health and an incremental-cost-effectiveness-ratio (ICER) of 7,071 €. Pre-treated patients showed similar trends, with medical-cost savings of 718 €, an ICER of 7,864 €, and a quality-of-life improvement of 4.2 months. Higher effectiveness (+5%) led to an additional 8.3 months in perfect health and a reduction in overall costs. Conclusion The analysis demonstrates that the Floodlight® MS app is a cost-effective digital health application, encouraging broader discussions on maximizing the potential of software-as-medical-devices within the care pathway.

2024-07-01·Cancer Chemotherapy and Pharmacology

Phase I pharmacokinetic, safety, and preliminary efficacy study of tiragolumab in combination with atezolizumab in Chinese patients with advanced solid tumors

Article

作者: Wu, Benjamin ; Liu, Qi ; Ding, Hao ; Wang, Yongsheng ; An, Andrew ; Chen, Yih-Wen ; Chan, Phyllis ; Shemesh, Colby S ; Wang, Xian ; Wu, Qiong

AbstractPurposeTiragolumab is an immunoglobulin G1 monoclonal antibody targeting the immune checkpoint T cell immunoreceptor with immunoglobulin and immunoreceptor ITIM domains. Targeting multiple immune pathways may improve anti-tumor responses. The phase I YP42514 study assessed the pharmacokinetics (PK), safety, and preliminary efficacy of tiragolumab plus atezolizumab in Chinese patients with advanced solid tumors.MethodsAdult patients from mainland China with Eastern Cooperative Oncology Group performance score 0/1, life expectancy of ≥ 12 weeks, and adequate hematologic/end organ function were eligible. Patients received tiragolumab 600 mg and atezolizumab 1200 mg intravenous every 3 weeks. Key endpoints were PK (serum concentrations of tiragolumab and atezolizumab) and safety. Results from this study were compared with the global phase I study, GO30103 (NCT02794571).ResultsIn this study, 20 patients received a median of five doses of tiragolumab plus atezolizumab. Median age was 57.5 years, 85.0% of patients were male and the most common tumor type was non-small cell lung cancer. Exposures in Chinese patients were comparable to the global GO30103 population: geometric mean ratio was 1.07 for Cycle 1 tiragolumab area under the concentration–time curve0–21 and 0.92 and 0.93 for Cycle 1 peak and trough atezolizumab exposure, respectively. Treatment-related adverse events were consistent across the Chinese and global populations. Two patients (10.0%) in this study achieved a partial response.ConclusionIn this study, tiragolumab plus atezolizumab was tolerable and demonstrated preliminary anti-tumor activity. There were no meaningful differences in the PK or safety of tiragolumab plus atezolizumab between the Chinese and global populations.Clinical trial registration number: China Clinical Trial Registry Identifier CTR20210219/YP42514. Date of registration 16 March 2021.

2024-06-01·Neuroscience & Biobehavioral Reviews

Dysfunctions of cellular context-sensitivity in neurodevelopmental learning disabilities

Review

作者: Granato, Alberto ; Larkum, Matthew E ; Phillips, William A ; Schulz, Jan M ; Suzuki, Mototaka

Pyramidal neurons have a pivotal role in the cognitive capabilities of neocortex. Though they have been predominantly modeled as integrate-and-fire point processors, many of them have another point of input integration in their apical dendrites that is central to mechanisms endowing them with the sensitivity to context that underlies basic cognitive capabilities. Here we review evidence implicating impairments of those mechanisms in three major neurodevelopmental disabilities, fragile X, Down syndrome, and fetal alcohol spectrum disorders. Multiple dysfunctions of the mechanisms by which pyramidal cells are sensitive to context are found to be implicated in all three syndromes. Further deciphering of these cellular mechanisms would lead to the understanding of and therapies for learning disabilities beyond any that are currently available.

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