15 results match your criteria: "Department of Clinical and Regulatory Affairs[Affiliation]"
Front Oncol
April 2024
Department of Clinical and Regulatory Affairs, Arcellx Inc, Redwood City, CA, United States.
Chin J Cancer Res
October 2023
Department of Gastrointestinal Oncology, the Fifth Medical Center, Chinese PLA General Hospital, Beijing 100071, China.
Objective: Currently, pre-treatment prediction of patients with pancreatic neuroendocrine tumors with liver metastases (PNELM) receiving surufatinib treatment was unsatisfying. Our objective was to examine the association between radiological characteristics and efficacy/prognosis.
Methods: We enrolled patients with liver metastases in the phase III, SANET-p trial (NCT02589821) and obtained contrast-enhanced computed tomography (CECT) images.
Expert Rev Clin Pharmacol
June 2023
Department of Clinical Pharmacology Sciences, Gilead Sciences, Foster City.
Introduction: Bladder cancer (BC) is the sixth most common type of cancer with epithelial/urothelial and non-urothelial origins. Urothelial carcinoma (UC) involves neoplastic cells of epithelial origin and accounts for 90% of all BC cases. Current review aims to discuss the latest advances and challenges in the treatment of UC with an emphasis on clinical pharmacology considerations.
View Article and Find Full Text PDFJ Immunother Cancer
December 2022
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida, USA.
The potential of chimeric antigen receptor (CAR) T cells to successfully treat hematological cancers is widely recognized. Multiple CAR-T cell therapies are currently under clinical development, with most in early stage, during which dose selection is a key goal. The objective of this review is to address the question of dose-dependent effects on response and/or toxicity from available CAR-T cell clinical trial data.
View Article and Find Full Text PDFEur J Cancer
January 2023
Department of Clinical and Regulatory Affairs, HUTCHMED, Shanghai, China.
Eur J Cancer
July 2022
Department of Clinical and Regulatory Affairs, HUTCHMED, Shanghai, China.
Aim: To investigate the health-related quality of life (HRQoL) of patients who had neuroendocrine tumors (NETs) from SANET trials.
Methods: Eligible patients were randomized in a 2:1 ratio to receive surufatinib or placebo. HRQoL questionnaires, including the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-G.
Background: No validated biomarkers currently exist for predicting the efficacy outcomes in patients with neuroendocrine tumors (NETs) treated with antiangiogenic therapy. We aimed to evaluate the association between treatment-related adverse events (TRAEs) and efficacy outcomes of surufatinib in patients with advanced NET.
Patients And Methods: We included patients with NET treated with surufatinib in two multicenter, randomized, double-blind, placebo-controlled, phase III trials (SANET-p and SANET-ep) in this study.
Pain Manag
January 2022
Department of Clinical and Regulatory Affairs, Nevro Corp., Redwood City, CA 94065, USA.
Chronic postsurgical pain (CPSP) is a common complication of surgery. This study was conducted to evaluate the efficacy and safety of paresthesia-free, 10-kHz spinal cord stimulation (SCS) as a treatment for CPSP. Subjects in this prospective, single-arm study had an average pain intensity of ≥5 cm on a 10-cm visual analog scale.
View Article and Find Full Text PDFJ Korean Med Sci
July 2021
Department of Preventive Medicine, Wonju College of Medicine, Yonsei University, Wonju, Korea.
Lancet Oncol
November 2020
Department of Clinical and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.
Background: Surufatinib showed superior efficacy in extrapancreatic neuroendocrine tumours (NETs) in the phase 3 SANET-ep study. In SANET-p, we aimed to assess the efficacy and safety of surufatinib in patients with advanced pancreatic NETs.
Methods: SANET-p was a multicentre, randomised, double-blind, placebo-controlled, phase 3 study, done in 21 hospitals across China.
CNS Oncol
March 2019
John Wayne Cancer Institute & Pacific Neuroscience Institute, Department of Translational Neurooncology and Neurotherapeutics, Santa Monica, CA, 90404, USA.
Aim: Evaluation of the Nativis Voyager, an investigational medical device, as monotherapy for recurrent glioblastoma (rGBM).
Materials & Methods: A total of 15 patients with rGBM were treated with one of two Voyager ultra-low radio frequency energy cognates: A1A or A2HU. Safety and clinical utility were assessed every 2-4 months.
Methods Mol Biol
June 2019
Department of Clinical Pharmacology, Genentech Research and Early Development, South San Francisco, CA, USA.
Metastatic melanoma is a dreadful type of skin cancer arising due to uncontrolled proliferation of melanocytes. It has very poor prognosis, low 5-year survival rates and until recently there were only handful of treatment options for metastatic melanoma patients. The drugs that were approved for the treatment had low response rates and were associated with severe adverse events.
View Article and Find Full Text PDFWorld J Gastroenterol
February 2005
Department of Clinical and Regulatory Affairs, Biological E.Limited, 18/1 and 3 Azamabad, Hyderabad, Zip-500020, India.
Aim: To establish the safety and efficacy of an indigenously developed r-hepatitis B vaccine using an accelerated schedule and to highlight the social awareness and commitment in preventing the spreading of hepatitis B virus infection.
Methods: The study was a multicentric, double blind, randomized (3:1) study using three doses of vaccine immunization schedule (20 mug for those above 10 years old and 10 mug for those below 10 years old) on d 0, 30 and 60. One hundred and sixty-six subjects were enrolled (87 males and 76 females aged 5-35 years).
Pharmacotherapy
August 2004
Department of Clinical and Regulatory Affairs, Nobex Corporation, Research Triangle Park, North Carolina, USA.
Study Objective: To assess the preliminary pharmacokinetics, pharmacodynamics, safety, and tolerability of single oral doses of a chemically modified salmon calcitonin product, CT-025, in healthy volunteers.
Design: Phase I, exploratory, five-way, open-label, nonrandomized, crossover study.
Setting: Clinical research center.
Urology
May 1995
Department of Clinical and Regulatory Affairs, Hybritech Incorporated, San Diego, California, USA.
Without question, much has been learned about the glycoprotein PSA in recent years. By increasing our understanding of this tumor marker's biochemical and physiologic properties, we will be able to improve its clinical utility. The discovery of the various molecular forms of PSA represents a significant advancement.
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