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Phase III clinical trial

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https://www.readbyqxmd.com/read/28732369/efficacy-and-safety-of-accelerated-partial-breast-irradiation-a-meta-analysis-of-published-randomized-studies
#1
Gengchun Liu, Zhongyi Dong, Baqun Huang, Yuelong Liu, Yan Tang, Qing Li, Yihui Zhu
BACKGROUND AND PURPOSE: Accelerated partial breast irradiation (APBI) technology has theoretical advantages in comparison with traditional adjuvant radiation therapy (whole-breast irradiation; WBI) after breast-conserving surgery. However, published randomized controlled trials have shown inconsistent outcomes. Therefore, a comprehensive assessment of the effectiveness and safety of APBI technology is needed. RESULTS: A total of 7 studies of 7452 patients were included in this analysis...
July 13, 2017: Oncotarget
https://www.readbyqxmd.com/read/28732152/secukinumab-in-the-treatment-of-psoriasis-and-psoriatic-arthritis-a-review-of-the-literature
#2
M Abrouk, J Gandy, M Nakamura, K Lee, M Brodsky, R Singh, H Zhu, B Farahnik, T Bhutani, J Koo
While there are several commercially available treatment options for psoriasis and psoriatic arthritis, there remains a large number of individuals who are refractory to current modalities. In the recent past, there has been increasing evidence that interleukin (IL)-17 plays a vital role in the pathophysiology of psoriasis. Preclinical, phase II, and phase III studies of secukinumab (Cosentyx®) targeting IL-17 and its receptor have thus far proved to be promising. We reviewed the results of phase II and phase III clinical trials for secukinumab in the treatment of psoriasis and psoriatic arthritis...
July 2017: Skin Therapy Letter
https://www.readbyqxmd.com/read/28730885/ataluren-in-cystic-fibrosis-development-clinical-studies-and-where-are-we-now
#3
Noreen Zainal Abidin, Iram J Haq, Aaron I Gardner, Malcolm Brodlie
Cystic fibrosis (CF) is one of the most common genetically-acquired life-limiting conditions worldwide. The underlying defect is dysfunction of the cystic fibrosis transmembrane-conductance regulator (CFTR) which leads to progressive lung disease and other multi-system effects. Around 10% of people with CF have a class I nonsense mutation that leads to production of shortened CFTR due to a premature termination codon (PTC). Areas covered: We discuss the discovery of the small-molecule drug ataluren, which in vitro has been shown to allow read-through of PTCs and facilitate synthesis of full-length protein...
July 21, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28730115/diabetic-macular-edema-in-proliferative-stage-treated-with-anti-vascular-endothelial-growth-factor-agent-and-triamcinolone-acetonide-by-laser-based-strategies
#4
Gang Qiao, Wan-Jiang Dong, Yan Dai, Zhen-Hua Jiang, Hai-Ke Guo
AIM: To appraise the effect of treatment for diabetic macular edema (DME) in proliferative stage with sufficient panrentinal photocoagulation (PRP) therapy and intravitreal injections (IV) Conbercept and posterior subtenon's triamcinolone acetonide (STTA) sequential therapy. METHODS: This prospective clinical randomized controlled trial of cross-over design was conducted in three phases. The participants included cases of DME in proliferative stage. They were divided into two groups and treated with PRP before enrollment...
2017: International Journal of Ophthalmology
https://www.readbyqxmd.com/read/28728599/a-phase-iii-randomized-two-armed-double-blind-parallel-active-controlled-and-non-inferiority-clinical-trial-to-compare-efficacy-and-safety-of-biosimilar-adalimumab-cinnora%C3%A2-to-the-reference-product-humira%C3%A2-in-patients-with-active-rheumatoid-arthritis
#5
Ahmadreza Jamshidi, Farhad Gharibdoost, Mahdi Vojdanian, Soosan G Soroosh, Mohsen Soroush, Arman Ahmadzadeh, Mohammad Ali Nazarinia, Mohammad Mousavi, Hadi Karimzadeh, Mohammad Reza Shakibi, Zahra Rezaieyazdi, Maryam Sahebari, Asghar Hajiabbasi, Ali Asghar Ebrahimi, Najmeh Mahjourian, Amin Mohammadinejad Rashti
BACKGROUND: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). METHODS: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7...
July 20, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28728489/idarucizumab-for-the-treatment-of-hemorrhage-and-dabigatran-reversal-in-patients-requiring-urgent-surgery-or-procedures
#6
Ovidiu Vornicu, Anne-Sophie Larock, Anne-Sophie Dincq, Jonathan Douxfils, Jean-Michel Dogné, François Mullier, Sarah Lessire
Idarucizumab is a specific antagonist for dabigatran etexilate (DE). The recent market authorization of idarucizumab in Europe and the USA may reassure prescribers of DE, as it can increase the safety of the emergency management of patients taking this anticoagulant. However, idarucizumab use should be limited to specific indications to avoid unnecessary risks to patients and costs to healthcare systems. Areas covered: The authors provide an overview of idarucizumab development and its pharmacokinetic and pharmacodynamic properties...
July 20, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28724419/real-life-clinical-practice-results-with-vinflunine-in-patients-with-relapsed-platinum-treated-metastatic-urothelial-carcinoma-an-italian-multicenter-study-movie-goirc-01-2014
#7
Rodolfo Passalacqua, Silvia Lazzarelli, Maddalena Donini, Rodolfo Montironi, Rosa Tambaro, Ugo De Giorgi, Sandro Pignata, Raffaella Palumbo, Giovanni Luca Ceresoli, Gianluca Del Conte, Giuseppe Tonini, Franco Morelli, Franco Nolè, Stefano Panni, Ermanno Rondini, Annalisa Guida, Paolo Andrea Zucali, Laura Doni, Elisa Iezzi, Caterina Caminiti
BACKGROUND: Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice...
July 19, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28723910/estimating-mono-and-bi-phasic-regression-parameters-using-a-mixture-piecewise-linear-bayesian-hierarchical-model
#8
Rui Zhao, Paul Catalano, Victor G DeGruttola, Franziska Michor
The dynamics of tumor burden, secreted proteins or other biomarkers over time, is often used to evaluate the effectiveness of therapy and to predict outcomes for patients. Many methods have been proposed to investigate longitudinal trends to better characterize patients and to understand disease progression. However, most approaches assume a homogeneous patient population and a uniform response trajectory over time and across patients. Here, we present a mixture piecewise linear Bayesian hierarchical model, which takes into account both population heterogeneity and nonlinear relationships between biomarkers and time...
2017: PloS One
https://www.readbyqxmd.com/read/28722322/advanced-methods-for-dose-and-regimen-finding-during-drug-development-summary-of-the-ema-efpia-workshop-on-dose-finding-london-4-5-december-2014
#9
F T Musuamba, E Manolis, N Holford, Sya Cheung, L E Friberg, K Ogungbenro, M Posch, Jwt Yates, S Berry, N Thomas, S Corriol-Rohou, B Bornkamp, F Bretz, A C Hooker, P H Van der Graaf, J F Standing, J Hay, S Cole, V Gigante, K Karlsson, T Dumortier, N Benda, F Serone, S Das, A Brochot, F Ehmann, R Hemmings, I Skottheim Rusten
Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regulatory institutions. In an effort to shift the current paradigm in dose and regimen selection and highlight the availability and usefulness of well-established and regulatory-acceptable methods, the European Medicines Agency (EMA) in collaboration with the European Federation of Pharmaceutical Industries Association (EFPIA) hosted a multistakeholder workshop on dose finding (London 4-5 December 2014)...
July 19, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28721753/nintedanib-in-ovarian-cancer
#10
Saira Khalique, Susana Banerjee
Advanced ovarian cancer remains an unmet clinical need. Angiogenesis is considered a therapeutic target in ovarian cancer, with bevacizumab, a monoclonal antibody against VEGF, being the first drug to show a progression-free survival benefit. Nintedanib is an oral tyrosine kinase inhibitor targeting VEGF receptor 1-3, FGFR 1-3 and PDGFR α and β, which has entered phase III trial development in ovarian cancer. Areas covered: This article reviews the preclinical and clinical efficacy of nintedanib in ovarian cancer, its pharmacokinetic and pharmacodynamics profile, safety issues, together with an overview of clinical trials carried out so far...
July 19, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28721050/the-use-of-natalizumab-for-multiple-sclerosis
#11
REVIEW
Rachel Brandstadter, Ilana Katz Sand
Natalizumab is a monoclonal antibody that acts as an α4 integrin antagonist to prevent leukocyte trafficking into the central nervous system. It is US Food and Drug Administration (FDA) approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). Natalizumab demonstrated high efficacy in Phase III trials by reducing the annualized relapse rate, preventing multiple sclerosis (MS) lesion accumulation on magnetic resonance imaging, and decreasing the probability of sustained progression of disability...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28720442/impact-of-baseline-covariates-on-the-immunogenicity-of-the-9-valent-hpv-vaccine-a-combined-analysis-of-five-phase-iii-clinical-trials
#12
Lone K Petersen, Jaime Restrepo, Edson D Moreira, Ole-Erik Iversen, Punnee Pitisuttithum, Pierre Van Damme, Elmar A Joura, Sven-Erik Olsson, Daron Ferris, Stan Block, Anna R Giuliano, Xavier Bosch, Sophie Pils, Jack Cuzick, Suzanne M Garland, Warner Huh, Susanne K Kjaer, Oliver M Bautista, Donna Hyatt, Roger Maansson, Erin Moeller, Hong Qi, Christine Roberts, Alain Luxembourg
BACKGROUND: The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed. METHODS: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen...
June 2017: Papillomavirus Research
https://www.readbyqxmd.com/read/28720336/baseline-symptom-score-impact-on-benefits-of-glycopyrrolate-formoterol-mdi-in-copd
#13
Fernando J Martinez, Leonardo M Fabbri, Gary T Ferguson, Chad Orevillo, Patrick Darken, Ubaldo J Martin, Colin Reisner
BACKGROUND: Chronic obstructive pulmonary disease (COPD) clinical severity is presently categorized by symptom burden and exacerbation risk. Previous 24-week Phase III trials (NCT01854645 and NCT01854658) that demonstrated better improvement of lung function with GFF MDI, a metered dose inhaler fixed-dose combination of glycopyrrolate/formoterol fumarate 18/9.6 μg, over individual monocomponent MDIs included a cross-section of patients with moderate-to-very severe airflow limitation and a broad range of COPD symptoms...
July 15, 2017: Chest
https://www.readbyqxmd.com/read/28720101/drug-candidates-in-clinical-trials-for-alzheimer-s-disease
#14
REVIEW
Shih-Ya Hung, Wen-Mei Fu
Alzheimer's disease (AD) is a major form of senile dementia, characterized by progressive memory and neuronal loss combined with cognitive impairment. AD is the most common neurodegenerative disease worldwide, affecting one-fifth of those aged over 85 years. Recent therapeutic approaches have been strongly influenced by five neuropathological hallmarks of AD: acetylcholine deficiency, glutamate excitotoxicity, extracellular deposition of amyloid-β (Aβ plague), formation of intraneuronal neurofibrillary tangles (NTFs), and neuroinflammation...
July 19, 2017: Journal of Biomedical Science
https://www.readbyqxmd.com/read/28720094/a-literature-review-of-applied-adaptive-design-methodology-within-the-field-of-oncology-in-randomised-controlled-trials-and-a-proposed-extension-to-the-consort-guidelines
#15
Pankaj Mistry, Janet A Dunn, Andrea Marshall
BACKGROUND: The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently...
July 18, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28719890/effect-of-neoadjuvant-nab-paclitaxel-plus-gemcitabine-therapy-on-overall-survival-in-patients-with-borderline-resectable-pancreatic-cancer-a-prospective-multicenter-phase-ii-trial-nac-ga-trial
#16
Ken-Ichi Okada, Toshio Shimokawa, Seiko Hirono, Manabu Kawai, Masayuki Sho, Sohei Satoi, Ippei Matsumoto, Hidetoshi Eguchi, Yoshiaki Murakami, Suguru Yamada, Mariko Doi, Hiroki Yamaue
We conducted a prospective multicenter phase II trial of patients with borderline resectable pancreatic carcinoma to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival (OS). The clinical trial primarily evaluated OS time from the first day of protocol therapy as a primary endpoint. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effect), morbidity based on the Clavien Dindo classification of more than III, response rate, preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization, reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography was available), chemotherapeutic effect grade based on Evans' classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of readmission, mortality), patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F (Japanese version), and peripheral sensory neuropathy assessed by the questionnaire of the FACT/GOG-NTX subscale (version 4; Japanese version)...
July 19, 2017: Oncology
https://www.readbyqxmd.com/read/28719498/incidence-of-active-tuberculosis-and-cohort-retention-among-adolescents-in-western-kenya
#17
Videlis Nduba, Anna H Van't Hoog, Ellen M H Mitchell, Martien Borgdorff, Kayla F Laserson
SETTING: Siaya County, with the highest tuberculosis notification rates in Kenya. OBJECTIVE: To determine the incidence of active tuberculosis and one year cohort retention in 12-18 year old adolescents, in preparation for Phase III tuberculosis vaccine trials. METHODS: Adolescents were enrolled and followed up for 1-2 years to determine tuberculosis incidence. Adolescents with a positive tuberculin skin test (TST), history of cohabitation with a tuberculosis case, or at least one tuberculosis symptom received clinical and sputum examination and a chest radiograph...
July 14, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28716797/a-pragmatic-phase-iii-multisite-double-blind-placebo-controlled-parallel-arm-dose-increment-randomised-trial-of-regular-low-dose-extended-release-morphine-for-chronic-breathlessness-breathlessness-exertion-and-morphine-sulfate-beams-study-protocol
#18
David Currow, Gareth John Watts, Miriam Johnson, Christine F McDonald, John O Miners, Andrew A Somogyi, Linda Denehy, Nicola McCaffrey, Danny J Eckert, Philip McCloud, Sandra Louw, Lawrence Lam, Aine Greene, Belinda Fazekas, Katherine C Clark, Kwun Fong, Meera R Agar, Rohit Joshi, Sharon Kilbreath, Diana Ferreira, Magnus Ekström
INTRODUCTION: Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD...
July 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28716370/a-systematic-review-and-framework-for-the-use-of-hormone-therapy-with-salvage-radiation-therapy-for-recurrent-prostate-cancer
#19
REVIEW
Daniel E Spratt, Robert T Dess, Zachary S Zumsteg, Daniel W Lin, Phuoc T Tran, Todd M Morgan, Emmanuel S Antonarakis, Paul L Nguyen, Charles J Ryan, Howard M Sandler, Matthew R Cooperberg, Edwin Posadas, Felix Y Feng
CONTEXT: Salvage radiotherapy (SRT) is a standard of care for men who recur postprostatectomy, and recent randomized trials have assessed the benefit and toxicity of adding hormone therapy (HT) to SRT with differing results. OBJECTIVE: To perform a systematic review of randomized phase III trials of the use of SRT ± HT and generate a framework for the use of HT with SRT. EVIDENCE ACQUISITION: Systematic literature searches were conducted on February 15, 2017 in three databases (MEDLINE [via PubMed], EMBASE, and ClinicalTrials...
July 14, 2017: European Urology
https://www.readbyqxmd.com/read/28713035/intracerebral-gene-therapy-in-children-with-mucopolysaccharidosis-type-iiib-syndrome-an-uncontrolled-phase-1-2-clinical-trial
#20
Marc Tardieu, Michel Zérah, Marie-Lise Gougeon, Jérome Ausseil, Stéphanie de Bournonville, Béatrice Husson, Dimitrios Zafeiriou, Giancarlo Parenti, Philippe Bourget, Béatrice Poirier, Valérie Furlan, Cécile Artaud, Thomas Baugnon, Thomas Roujeau, Ronald G Crystal, Christian Meyer, Kumaran Deiva, Jean-Michel Heard
BACKGROUND: Mucopolysaccharidosis type IIIB syndrome (also known as Sanfilippo type B syndrome) is a lysosomal storage disease resulting in progressive deterioration of cognitive acquisition after age 2-4 years. No treatment is available for the neurological manifestations of the disease. We sought to assess the safety and efficacy of a novel intracerebral gene therapy. METHODS: Local regulatory authorities in France allowed inclusion of up to four children in this phase 1/2 study...
July 13, 2017: Lancet Neurology
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