Clinical data Clausole campione
Clinical data. The safety and efficacy of lanreotide has been demonstrated in subjects with acromegaly or GEP NETs. Different formulations of lanreotide (including lanreotide Autogel 120 mg every 28 days) also produced similar results in other indications including cardiac disorders, GI bleeding, diabetes, thyrotropic adenoma, digestive fistulae, ophthalmic Graves disease and paediatric studies, where the types and percentages of related serious adverse events (SAEs) across indications were broadly similar and no specific safety concerns were identified.
1.5.3.1 Clinical data of efficacy in Subjects with Neuroendocrine Tumors Control of Symptoms Associated with NETs AntiProliferative Effect of Lanreotide in Subjects with Neuroendocrine Tumors Figure 4: ▇▇▇▇▇▇-▇▇▇▇▇ Curves of Progression-Free Survival
Clinical data. For the retrospective studies needed for the first two aims and the prospective study for aim 3, we will collect several clinical information, such as: -demographics: age, sex; -clinical (medical records and physical exam) information, including neurological examination; -neuropsychological tests (first and second level); -standard blood examination, such as fasting blood glucose, blood count, renal and hepatic function markers, thyroid function, vitamin B12, folates, homocysteine; -core AD-related cerebrospinal fluid liquid (CSF) biomarkers, in particular amyloid ß1-42, total tau, and phosphorylated tau; -radiological information (in terms of CT and MRI scans); -other assessments with PET or SPECT. Laboratory measurements Lumbar puncture At the baseline visit each patients undergo the Lumbar Puncture (LP). Five milliliters of CSF from each participant are collected. LP is performed in fasting condition according to the standardized protocol of the outpatient clinic, from 09:00 to 11:00 in the morning, after clinical informed written consent is obtained. CSF is collected in sterile polypropylene tubes and gently mixed to avoid gradient effects. CSF is centrifugated and firstly processed for standard biochemical analyses, whereas about three milliliters of CSF is stored in cryotubes at -80°C before biomarkers testing.
Clinical data. In clinical studies, cabozantinib has been evaluated in multiple tumor types including medullary thyroid cancer, castration-resistant prostate cancer, ovarian cancer, breast cancer, hepatocellular carcinoma, nonsmall cell lung cancer, melanoma, differentiated thyroid cancer, renal cell carcinoma, and glioblastoma multiforme. To date, cabozantinib has demonstrated a broad spectrum of clinical activity in these tumor types and has been approved for the treatment of progressive metastatic medullary thyroid carcinoma, hepatocellular carcinoma, renal cell carcinoma. Consult the Investigator’s Brochure of the drug for more details. (1)