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Phase III clinical trial

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https://www.readbyqxmd.com/read/29684049/clinical-factors-associated-with-early-progression-and-grade-3-4-toxicity-in-patients-with-advanced-non-small-cell-lung-cancers-treated-with-nivolumab
#1
Coraline Dumenil, Marie-Ange Massiani, Jennifer Dumoulin, Violaine Giraud, Sylvie Labrune, Thierry Chinet, Etienne Giroux Leprieur
INTRODUCTION: The prognosis of advanced non-small-cell lung cancer (NSCLC) has been improved by development of immune checkpoint inhibitors (ICIs) such as nivolumab for second-line treatment. As phase III trials include only selected patients, we here investigated the clinical factors associated with efficacy and safety of nivolumab in 'real life' patients with advanced NSCLC. METHODS: Clinical and histological characteristics, therapies and survival data of all consecutive patients with advanced NSCLC included prospectively and treated by nivolumab in two French academic hospitals between February 2015 and December 2016 were examined...
2018: PloS One
https://www.readbyqxmd.com/read/29682332/gender-and-outcomes-in-non-small-cell-lung-cancer-an-old-prognostic-variable-comes-back-for-targeted-therapy-and-immunotherapy
#2
Joseph A Pinto, Carlos S Vallejos, Luis E Raez, Luis A Mas, Rossana Ruiz, Junior S Torres-Roman, Zaida Morante, Jhajaira M Araujo, Henry L Gómez, Alfredo Aguilar, Denisse Bretel, Claudio J Flores, Christian Rolfo
Background: There are well-known differences in gender outcome in non-small cell lung cancer (NSCLC) and other cancers. In this work, we evaluated several randomised clinical trials to explore the gender influence in the outcome of patients with NSCLC treated with targeted therapy and immunotherapy. Methods: We performed a series of meta-analysis to compare the gender outcome in the routine setting for overall survival and progression-free survival (PFS) in phase III randomised clinical trials comparing EGFR inhibitors versus chemotherapy (OPTIMAL, LUX-lung 3, LUX-lung 6, EURTAC, ENSURE and WTJOG); ALK inhibitors versus chemotherapy (ASCEND 4, ASCEND 5, PROFILE 1014 and NCT009323893) and anti-PD1 checkpoint inhibitors versus chemotherapy (CheckMate 017, CheckMate 026, CheckMate 057, KEYNOTE 010 and KEYNOTE 024)...
2018: ESMO Open
https://www.readbyqxmd.com/read/29682195/results-and-adverse-events-of-personalized-peptide-receptor-radionuclide-therapy-with-90-yttrium-and-177-lutetium-in-1048-patients-with-neuroendocrine-neoplasms
#3
Richard P Baum, Harshad R Kulkarni, Aviral Singh, Daniel Kaemmerer, Dirk Mueller, Vikas Prasad, Merten Hommann, Franz C Robiller, Karin Niepsch, Holger Franz, Arthur Jochems, Philippe Lambin, Dieter Hörsch
Introduction: Peptide receptor radionuclide therapy (PRRT) of patients with somatostatin receptor expressing neuroendocrine neoplasms has shown promising results in clinical trials and a recently published phase III study. Methods: In our center, 2294 patients were screened between 2004 and 2014 by 68 Ga somatostatin receptor (SSTR) PET/CT. Intention to treat analysis included 1048 patients, who received at least one cycle of 90 Yttrium or 177 Lutetium-based PRRT...
March 30, 2018: Oncotarget
https://www.readbyqxmd.com/read/29680880/a-phase-iii-randomized-clinical-trial-of-a-0-5-timolol-0-2-brimonidine-2-0-dorzolamide-fixed-combination-preservative-free-ophthalmic-solution-vs-0-5-timolol-0-2-brimonidine-2-0-dorzolamide-fixed-combination-in-patients-with-controlled-primary-open-angle-glaucoma
#4
Francisco Gómez-Aguayo, José A Paczka, Rubén Leñero-Córdova, Jesús Jiménez-Román, Jaime Davila-Villarreal, Curt Hartleben, Leopoldo Baiza-Durán, Oscar Olvera-Montaño, Francisco García-Velez, Patricia Muñoz-Villegas
INTRODUCTION: The aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months. METHODS: In a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days...
April 21, 2018: Ophthalmology and Therapy
https://www.readbyqxmd.com/read/29680098/modeling-clinical-outcomes-in-prostate-cancer-application-and-validation-of-the-discrete-event-simulation-approach
#5
Feng Pan, Odette Reifsnider, Ying Zheng, Irina Proskorovsky, Tracy Li, Jianming He, Sonja V Sorensen
OBJECTIVES: Treatment landscape in prostate cancer has changed dramatically with the emergence of new medicines in the past few years. The traditional survival partition model (SPM) cannot accurately predict long-term clinical outcomes because it is limited by its ability to capture the key consequences associated with this changing treatment paradigm. The objective of this study was to introduce and validate a discrete-event simulation (DES) model for prostate cancer. METHODS: A DES model was developed to simulate overall survival (OS) and other clinical outcomes based on patient characteristics, treatment received, and disease progression history...
April 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29678987/protocol-for-a-phase-iii-non-inferiority-randomised-comparison-of-a-new-fibrinogen-concentrate-versus-cryoprecipitate-for-treating-acquired-hypofibrinogenaemia-in-bleeding-cardiac-surgical-patients-the-fibres-trial
#6
Keyvan Karkouti, Jeannie Callum, Vivek Rao, Nancy Heddle, Michael E Farkouh, Mark A Crowther, Damon C Scales
INTRODUCTION: Coagulopathic bleeding is a serious complication of cardiac surgery to which an important contributor is acquired hypofibrinogenaemia (plasma fibrinogen <1.5-2.0 g/L). The standard intervention for acquired hypofibrinogenaemia is cryoprecipitate, but purified fibrinogen concentrates are also available. There is little comparative data between the two therapies and randomised trials are needed. METHODS AND ANALYSIS: FIBrinogen REplenishment in Surgery (FIBRES) is a multicentre, randomised (1:1), active-control, single-blinded, phase III trial in adult cardiac surgical patients experiencing clinically significant bleeding related to acquired hypofibrinogenaemia...
April 20, 2018: BMJ Open
https://www.readbyqxmd.com/read/29675787/meropenem-vaborbactam-a-carbapenem-and-beta-lactamase-inhibitor-with-activity-against-carbapenem-resistant-enterobacteriaceae
#7
REVIEW
Young R Lee, Nathaniel T Baker
Meropenem-vaborbactam is a carbapenem and β-lactamase inhibitor combination that is newly indicated for the treatment of complicated urinary tract infections (cUTI), including adult pyelonephritis. Vaborbactam was developed due to emergence of carbapenem-resistant strains of Enterobacteriaceae. In a phase I trial, patients that received meropenem-vaborbactam 2-2 g intravenously over 3 h every 8 h, Cmax was 58.2 ± 10.8 μg/mL for meropenem and 59.0 ± 8.4 μg/mL for vaborbactam. AUC0-8 was 186 ± 33...
April 19, 2018: European Journal of Clinical Microbiology & Infectious Diseases
https://www.readbyqxmd.com/read/29673712/update-on-systemic-prostate-cancer-therapies-management-of-metastatic-castration-resistant-prostate-cancer-in-the-era-of-precision-oncology
#8
REVIEW
Philipp Nuhn, Johann S De Bono, Karim Fizazi, Stephen J Freedland, Maurizio Grilli, Philip W Kantoff, Guru Sonpavde, Cora N Sternberg, Srinivasan Yegnasubramanian, Emmanuel S Antonarakis
CONTEXT: Introduction of novel agents for the management of advanced prostate cancer provides a range of treatment options with notable benefits for men with metastatic castration-resistant prostate cancer (mCRPC). At the same time, understanding of optimal patient selection, effective sequential use, and development of resistance patterns remains incomplete. OBJECTIVE: To review current systemic therapies and recent advances in drug development for mCRPC and strategies to aid in patient selection and optimal sequencing...
April 16, 2018: European Urology
https://www.readbyqxmd.com/read/29672874/review-article-novel-oral-targeted-therapies-in-inflammatory-bowel-disease
#9
REVIEW
J R White, F Phillips, T Monaghan, W Fateen, S Samuel, S Ghosh, G W Moran
BACKGROUND: There is a great unmet clinical need for efficacious, tolerable, economical and orally administrated drugs for the treatment of inflammatory bowel disease (IBD). New therapeutic avenues have become possible including the development of medications that target specific genetic pathways found to be relevant in other immune mediated diseases. AIMS: To provide an overview of recent clinical trials for new generation oral targeted medications that may have a future role in IBD management...
April 19, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29672182/oral-anticoagulant-use-in-cardiovascular-disorders-a-perspective-on-present-and-potential-indications-for-rivaroxaban
#10
A John Camm, Keith A A Fox
BACKGROUND: Four nonvitamin K antagonist oral anticoagulants (NOACs) have been approved for use in various cardiovascular indications. The direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors apixaban, edoxaban, and rivaroxaban are now increasingly used in clinical practice. For some of these agents, available data from real-world studies support the efficacy and safety data in phase III clinical trials. OBJECTIVES: This review aims to summarize the current status of trials and observational studies of oral anticoagulant use over the spectrum of cardiovascular disorders (excluding venous thrombosis), provide a reference source beyond stroke prevention for atrial fibrillation (AF) and examine the potential for novel applications in the cardiovascular field...
April 19, 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29671219/ceftazidime-avibactam-a-review-in-the-treatment-of-serious-gram-negative-bacterial-infections
#11
Matt Shirley
Ceftazidime-avibactam (Zavicefta® ) is an intravenously administered combination of the third-generation cephalosporin ceftazidime and the novel, non-β-lactam β-lactamase inhibitor avibactam. In the EU, ceftazidime-avibactam is approved for the treatment of adults with complicated urinary tract infections (cUTIs) [including pyelonephritis], complicated intra-abdominal infections (cIAIs), hospital-acquired pneumonia (HAP) [including ventilator-associated pneumonia (VAP)], and other infections caused by aerobic Gram-negative organisms in patients with limited treatment options...
April 18, 2018: Drugs
https://www.readbyqxmd.com/read/29670674/tiotropium-for-the-treatment-of-asthma-patient-selection-and-perspectives
#12
REVIEW
V Madhu Chari, Robert Andrew McIvor
Asthma is a chronic disease of airway inflammation with a large global burden. Despite established, guideline-based stepwise therapy, a significant proportion of patients remain symptomatic and poorly controlled. As such, there is a need for additional safe, effective, convenient, and cost-effective therapies that can be broadly applied across a range of asthma phenotypes. Tiotropium is a long-acting muscarinic antagonist (LAMA) that leads to bronchodilation by blocking endogenous acetylcholine receptors in the airways...
2018: Canadian Respiratory Journal: Journal of the Canadian Thoracic Society
https://www.readbyqxmd.com/read/29670334/aldoxorubicin-a-tumor-targeted-doxorubicin-conjugate-for-relapsed-or-refractory-soft-tissue-sarcomas
#13
REVIEW
Jun Gong, Jessica Yan, Charles Forscher, Andrew Hendifar
Despite available therapies after initial systemic therapy, prognosis remains poor in relapsed or refractory soft tissue sarcomas (STS). The rational and clinical development of novel agents to improve outcomes in this area of high unmet need is desperately warranted. Aldoxorubicin is a prodrug of doxorubicin that binds to serum albumin immediately after administration through an acid-sensitive hydrazone linker and is subsequently transported to tumor tissues where the acidic environment cleaves the linker and facilitates delivery of a tumor-targeted drug payload...
2018: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29669604/confirm-a-double-blind-placebo-controlled-phase-iii-clinical-trial-investigating-the-effect-of-nivolumab-in-patients-with-relapsed-mesothelioma-study-protocol-for-a-randomised-controlled-trial
#14
Dean A Fennell, Emma Kirkpatrick, Kelly Cozens, Mavis Nye, Jason Lester, Gerard Hanna, Nicola Steele, Peter Szlosarek, Sarah Danson, Joanne Lord, Christian Ottensmeier, Daniel Barnes, Stephanie Hill, Mihalis Kalevras, Tom Maishman, Gareth Griffiths
BACKGROUND: Mesothelioma is an incurable, apoptosis-resistant cancer caused in most cases by previous exposure to asbestos and is increasing in incidence. It represents a growing health burden but remains under-researched, with limited treatment options. Early promising signals of activity relating to both PD-L1- and PD-1-targeted treatment in mesothelioma implicate a dependency of mesothelioma on this immune checkpoint. There is a need to evaluate checkpoint inhibitors in patients with relapsed mesothelioma where treatment options are limited...
April 18, 2018: Trials
https://www.readbyqxmd.com/read/29669531/assessment-of-an-optimized-manufacturing-process-for-inactivated-quadrivalent-influenza-vaccine-a-phase-iii-randomized-double-blind-safety-and-immunogenicity-study-in-children-and-adults
#15
Carine Claeys, Mamadou Drame, José García-Sicilia, Khalequ Zaman, Alfonso Carmona, Phu My Tran, Mariano Miranda, Federico Martinón-Torres, Franck Thollot, Michael Horn, Tino F Schwarz, Ulrich Behre, José M Merino, Iwona Sadowska-Krawczenko, Henryk Szymański, Peter Schu, Elisabeth Neumeier, Ping Li, Varsha K Jain, Bruce L Innis
BACKGROUND: GSK has modified the licensed monovalent bulk manufacturing process for its split-virion inactivated quadrivalent influenza vaccine (IIV4) to harmonize the process among different strains, resulting in an increased number of finished vaccine doses, while compensating for the change from inactivated trivalent influenza vaccine (IIV3) to IIV4. To confirm the manufacturing changes do not alter the profile of the vaccine, a clinical trial was conducted to compare IIV4 made by the currently licensed process with a vaccine made by the new (investigational) process (IIV4-I)...
April 18, 2018: BMC Infectious Diseases
https://www.readbyqxmd.com/read/29669391/translational-biomarkers-and-ex-vivo-models-of-joint-tissues-as-a-tool-for-drug-development-in-rheumatoid-arthritis
#16
Cecilie F Kjelgaard-Petersen, Adam Platt, Martin Braddock, Martin A Jenkins, Kishwar Musa, Emma Graham, Thorbjørn Gantzel, Gillian Slynn, Michael E Weinblatt, Morten A Karsdal, Christian S Thudium, Anne-C Bay-Jensen
OBJECTIVE: Rheumatoid arthritis (RA) is a chronic, autoimmune and degenerative joint disease leading to disability, reduced life quality, and increased mortality. Although several synthetic and biological disease modifying anti-rheumatic drugs (DMARDs) are available, there is still a medical need for novel drugs controlling disease progression. As only 10% of RA drug candidates that enter phase I trials are eventually FDA registered, there is an immediate requirement for translational drug development tools to facilitate early drug development decision making...
April 18, 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29668601/efficacy-and-safety-of-once-weekly-semaglutide-for-the-treatment-of-type-2-diabetes-protocol-for-a-systematic-review-and-meta-analysis
#17
Fang-Hong Shi, Hao Li, Min Cui, Zai-Li Zhang, Zhi-Chun Gu, Xiao-Yan Liu
BACKGROUND: It is a great challenge for type 2 diabetes mellitus (T2DM) patients to maintain optimal glycemia, control body weight, blood pressure, and avoiding hypoglycemia. Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1 RAs) can stimulate glucose-dependent insulin while inhibit glucagon secretion, delay gastric emptying, reduce appetite, and energy intake. Recently, a new once-weekly GLP-1 RAs, semaglutide, has been registered to treat patients with T2DM. METHODS: We will search Medline, Embase, Cochrane Library, and the ClinicalTrials...
April 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29667842/the-role-of-pcsk9-inhibitors-in-the-treatment-of-hypercholesterolemia
#18
Roshni S Patel, Emily M Scopelliti, Oludamilola Olugbile
OBJECTIVE: To evaluate the efficacy, safety, and cost-effectiveness of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors and describe its place in therapy for the treatment of hypercholesterolemia. DATA SOURCES: A search of MEDLINE, CINAHL, and Clinicaltrials.gov was performed from January 2012 to March 2018 to identify literature pertaining to PCSK9 inhibitors using pre-specified search terms. Additional references were identified from citations of the literature...
April 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29667066/population-exposure-response-analysis-of-cabozantinib-efficacy-and-safety-endpoints-in-patients-with-renal-cell-carcinoma
#19
Steven Lacy, Jace Nielsen, Bei Yang, Dale Miles, Linh Nguyen, Matt Hutmacher
BACKGROUND: In the phase III METEOR trial, tyrosine kinase inhibitor cabozantinib significantly improved progression-free survival (PFS), objective response rate (ORR), and overall survival compared to everolimus in patients with advanced renal cell carcinoma (RCC) who had received prior VEGFR inhibitor therapy. In METEOR, RCC patients started at a daily 60-mg cabozantinib tablet (Cabometyx™) dose but could reduce to 40- or 20-mg to achieve a tolerated exposure. OBJECTIVES AND METHODS: Exposure-response (ER) models were developed to characterize the relationship between cabozantinib at clinically relevant exposures in RCC patients enrolled in METEOR and efficacy (PFS and tumor response) and safety endpoints...
April 17, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29666026/cervical-cancer-state-of-the-science-from-angiogenesis-blockade-to-checkpoint-inhibition
#20
REVIEW
Lindsey E Minion, Krishnansu S Tewari
Vascular endothelial growth factor (VEGF) has emerged as a therapeutic target in several malignancies, including cervical cancer. Chemotherapy doublets combined with the fully humanized monoclonal antibody, bevacizumab, now constitute first-line therapy for women struggling with recurrent/metastatic cervical carcinoma. Regulatory approval for this indication was based on the phase III randomized trial, GOG 240, which demonstrated a statistically significant and clinically meaningful improvement in overall survival when bevacizumab was added to chemotherapy: 17...
March 2018: Gynecologic Oncology
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