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https://www.readbyqxmd.com/read/27926729/intracellular-allosteric-antagonism-of-the-ccr9-receptor
#1
Christine Oswald, Mathieu Rappas, James Kean, Andrew S Doré, James C Errey, Kirstie Bennett, Francesca Deflorian, John A Christopher, Ali Jazayeri, Jonathan S Mason, Miles Congreve, Robert M Cooke, Fiona H Marshall
Chemokines and their G-protein-coupled receptors play a diverse role in immune defence by controlling the migration, activation and survival of immune cells. They are also involved in viral entry, tumour growth and metastasis and hence are important drug targets in a wide range of diseases. Despite very significant efforts by the pharmaceutical industry to develop drugs, with over 50 small-molecule drugs directed at the family entering clinical development, only two compounds have reached the market: maraviroc (CCR5) for HIV infection and plerixafor (CXCR4) for stem-cell mobilization...
December 7, 2016: Nature
https://www.readbyqxmd.com/read/27926714/pfizer-drops-phase-3-lipid-lowering-antibody
#2
(no author information available yet)
No abstract text is available yet for this article.
December 7, 2016: Nature Biotechnology
https://www.readbyqxmd.com/read/27925676/population-pharmacokinetics-and-exposure-response-relationship-of-carfilzomib-in-patients-with-multiple-myeloma
#3
Ying Ou, Sameer Doshi, Anh Nguyen, Fredrik Jonsson, Sanjay Aggarwal, Kanya Rajangam, Meletios A Dimopoulos, A Keith Stewart, Ashraf Badros, Kyriakos P Papadopoulos, David Siegel, Sundar Jagannath, Ravi Vij, Ruben Niesvizky, Richard Graham, Jenn Visich
A population pharmacokinetic (PK) model and exposure-response (E-R) analysis was developed using data collected from 5 phase 1b/2 and 2 phase 3 studies in subjects with multiple myeloma. Subjects receiving intravenous infusion on 2 consecutive days each week for 3 weeks (days 1, 2, 8, 9, 15, and 16) in each cycle at doses ranging from 15 to 20/56 mg/m(2) (20 mg/m(2) in cycle 1 and, if tolerated, escalated to 56 mg/m(2) on day 8 of cycle 1). The population PK analysis indicated that among all the covariates tested, the only statistically significant covariate was body surface area on carfilzomib clearance; however, this covariate was unlikely to be clinically significant...
December 7, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27923779/a-multidisciplinary-model-to-guide-employment-outcomes-among-people-living-with-spinal-cord-injuries-in-south-africa-a-mixed-methods-study-protocol
#4
Ntsikelelo Pefile, Joyce Mothabeng, Saloshni Naidoo
BACKGROUND: Spinal cord injury (SCI) often results in complete or partial loss of functioning of the upper and/or lower limbs, leading to the affected individual experiencing difficulties in performing activities of daily living. This results in reduced participation in social, religious, recreational, and economic activities (employment). The South Africa legal framework promotes the employment and assistance of people with disabilities. However, rehabilitation interventions focus mainly on impairments and activity limitations, with few attempts to prepare those with SCI to return to gainful employment...
December 6, 2016: JMIR Research Protocols
https://www.readbyqxmd.com/read/27923693/post-treatment-resistance-analysis-of-hepatitis-c-virus-from-phase-2-and-3-clinical-trials-of-ledipasvir-sofosbuvir
#5
David Wyles, Hadas Dvory-Sobol, Evguenia S Brian Svarovskaia Doehle, Ross Martin, Nezam H Afdhal, Kris V Kowdley, Eric Lawitz, Diana M Brainard, Michael D Miller, Hongmei Mo, Edward J Gane
BACKGROUND & AIMS: Ledipasvir/sofosbuvir combination treatment in phase 3 clinical trials, resulted in sustained viral suppression in 94%-99% of patients. Characterization of drug resistance in treatment failures may help inform retreatment options. METHODS: We performed NS5A and NS5B deep sequencing of HCV from patients infected with genotype (GT) 1 who participated in ledipasvir/sofosbuvir phase 2 and 3 clinical trials. RESULTS: Fifty-one of 2144 (2...
December 3, 2016: Journal of Hepatology
https://www.readbyqxmd.com/read/27923550/treatment-design-and-rationale-for-a-randomized-trial-of-cisplatin-and-etoposide-plus-thoracic-radiotherapy-followed-by-nivolumab-or-placebo-for-locally-advanced-non-small-cell-lung-cancer-rtog-3505
#6
David E Gerber, James J Urbanic, Corey Langer, Chen Hu, I-Fen Chang, Bo Lu, Benjamin Movsas, Robert Jeraj, Walter J Curran, Jeffrey D Bradley
Radiation Therapy Oncology Group (RTOG) 3505 is a randomized phase 3 study of concurrent chemoradiation followed by immune checkpoint inhibitor therapy or placebo in patients with locally advanced non-small-cell lung cancer (NSCLC). Patients with surgically unresectable stage 3 NSCLC will receive thoracic radiotherapy to 60 Gy with concurrent cisplatin 50 mg/m(2) intravenously (I.V.) on days 1, 8, 29, and 36, and etoposide 50 mg/m(2) I.V. on days 1 to 5 and days 29 to 33. Between 4 and 12 weeks after completion of concurrent chemoradiation, eligible patients will be randomized to the anti-programmed death 1 (PD-1) monoclonal antibody nivolumab 240 mg I...
October 26, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/27922936/the-rejoice-trial-a-phase-3-randomized-controlled-trial-evaluating-the-safety-and-efficacy-of-a-novel-vaginal-estradiol-soft-gel-capsule-for-symptomatic-vulvar-and-vaginal-atrophy
#7
Ginger D Constantine, James A Simon, James H Pickar, David F Archer, Harvey Kushner, Brian Bernick, Gina Gasper, Shelli Graham, Sebastian Mirkin
OBJECTIVE: To evaluate the safety and efficacy of TX-004HR vaginal estradiol soft-gel capsules for moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy. METHODS: In this randomized, double-blind, placebo-controlled, phase 3 study, postmenopausal women with a self-identified most bothersome symptom of dyspareunia received 4, 10, or 25 μg TX-004HR or placebo for 12 weeks. Four co-primary efficacy endpoints were change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia...
December 5, 2016: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/27922029/safety-of-eluxadoline-in-patients-with-irritable-bowel-syndrome-with-diarrhea
#8
Brooks D Cash, Brian E Lacy, Philip S Schoenfeld, Leonard S Dove, Paul S Covington
OBJECTIVES: Eluxadoline is a mixed μ-opioid receptor (OR) and κ-OR agonist and δ-OR antagonist, approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D). This analysis evaluated the safety and tolerability of eluxadoline 75 and 100 mg twice daily (BID) in one Phase 2 (IBS-2001) and two Phase 3 (IBS-3001 and IBS-3002) studies. METHODS: Adults with IBS-D (Rome III criteria) were randomized to placebo or eluxadoline (75 or 100 mg) BID for 12 (IBS-2001), 26 (IBS-3002), or 52 (IBS-3001) weeks...
December 6, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27920805/abaloparatide
#9
REVIEW
Stefano Gonnelli, Carla Caffarelli
Abaloparatide is an investigational analog of human PTHrP (1-34) being developed for the treatment of osteoporosis. The amino-acid sequence of abaloparatide is identical to that of PTHrP in the first 20 amino-acids, while over half of the remaining amino-acids are different. Some studies in animals and in humans reported that abaloparatide presented a potent anabolic activity with reduced effects on bone resorption as compared to that observed with teriparatide. This may be due to a more transient signaling response of abaloparatide related to differing affinities of the two drugs to the specific conformations of the PTH1 receptor...
May 2016: Clinical Cases in Mineral and Bone Metabolism
https://www.readbyqxmd.com/read/27919786/increasing-in-cysteine-proteinase-b-expression-and-enzymatic-activity-during-in-vitro-differentiation-of-leishmania-viannia-braziliensis-first-evidence-of-modulation-during-morphological-transition
#10
Cinthia Bernardes Gomes, Franklin Souza da Silva, Karen Dos Santos Charret, Bernardo Acácio Santini Pereira, Léa Cysne Finkelstein, Raquel Santos de Souza, Luzia Monteiro de Castro Côrtes, Mirian Claudia Souza Pereira, Francisco Odêncio Rodrigues de Oliveira, Carlos Roberto Alves
Leishmania (Viannia) braziliensis presents adaptive protease-dependent mechanisms, as cysteine proteinases B (CPB). This work focuses on the expression of three cpb gene isoforms and CPB enzymatic activity during the parasite differentiation. Relative expression levels of LbrM.08.0810 gene was assessed, showing a higher quantity of transcripts in the logarithmic promastigotes phase than in the stationary promastigotes phase (> 1.5 times). The cbp gene tends to decrease during acid pH shock and increases when the temperature rises (> 1...
December 2, 2016: Biochimie
https://www.readbyqxmd.com/read/27919497/comparative-efficacy-and-discontinuation-of-dimethyl-fumarate-and-fingolimod-in-clinical-practice-at-12-month-follow-up
#11
Carrie M Hersh, Thomas E Love, Samuel Cohn, Claire Hara-Cleaver, Robert A Bermel, Robert J Fox, Jeffrey A Cohen, Daniel Ontaneda
BACKGROUND: Dimethyl fumarate (DMF) and fingolimod (FTY) are approved oral disease modifying therapies (DMT) for relapsing multiple sclerosis (MS). Phase 3 trials established these agents as effective and generally well tolerated, though comparative efficacy and discontinuation remain unknown. OBJECTIVE: To assess real-world efficacy and discontinuation of DMF and FTY over 12 months in patients with MS. METHODS: We identified 458 DMF-treated and 317 FTY-treated patients in a large academic MS center...
November 2016: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/27919222/capsaicin-8-patch-repeat-treatment-plus-standard-of-care-soc-versus-soc-alone-in-painful-diabetic-peripheral-neuropathy-a-randomised-52-week-open-label-safety-study
#12
Aaron I Vinik, Serge Perrot, Etta J Vinik, Ladislav Pazdera, Hélène Jacobs, Malcolm Stoker, Stephen K Long, Robert J Snijder, Marjolijne van der Stoep, Enrique Ortega, Nathaniel Katz
BACKGROUND: This 52-week study evaluated the long-term safety and tolerability of capsaicin 8% w/w (179 mg) patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy (PDPN). METHODS: Phase 3, multinational, open-label, randomised, controlled, 52-week safety study, conducted in Europe. Patients were randomised to capsaicin 8% patch repeat treatment (30 or 60 min; 1-7 treatments with ≥ 8-week intervals) to painful areas of the feet plus SOC, or SOC alone...
December 6, 2016: BMC Neurology
https://www.readbyqxmd.com/read/27918780/effect-of-a-proposed-trastuzumab-biosimilar-compared-with-trastuzumab-on-overall-response-rate-in-patients-with-erbb2-her2-positive-metastatic-breast-cancer-a-randomized-clinical-trial
#13
Hope S Rugo, Abhijit Barve, Cornelius F Waller, Miguel Hernandez-Bronchud, Jay Herson, Jinyu Yuan, Rajiv Sharma, Mark Baczkowski, Mudgal Kothekar, Subramanian Loganathan, Alexey Manikhas, Igor Bondarenko, Guzel Mukhametshina, Gia Nemsadze, Joseph D Parra, Maria Luisa T Abesamis-Tiambeng, Kakhaber Baramidze, Charuwan Akewanlop, Ihor Vynnychenko, Virote Sriuranpong, Gopichand Mamillapalli, Sirshendu Ray, Eduardo P Yanez Ruiz, Eduardo Pennella
Importance: Treatment with the anti-ERBB2 humanized monoclonal antibody trastuzumab and chemotherapy significantly improves outcome in patients with ERBB2 (HER2)-positive metastatic breast cancer; a clinically effective biosimilar may help increase access to this therapy. Objective: To compare the overall response rate and assess the safety of a proposed trastuzumab biosimilar plus a taxane or trastuzumab plus a taxane in patients without prior treatment for ERBB2-positive metastatic breast cancer...
December 1, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27918764/effect-of-fluorouracil-leucovorin-and-oxaliplatin-with-or-without-onartuzumab-in-her2-negative-met-positive-gastroesophageal-adenocarcinoma-the-metgastric-randomized-clinical-trial
#14
Manish A Shah, Yung-Jue Bang, Florian Lordick, Maria Alsina, Meng Chen, Stephen P Hack, Jean Marie Bruey, Dustin Smith, Ian McCaffery, David S Shames, See Phan, David Cunningham
Importance: Dysregulation of the mesenchymal-epithelial transition (MET) signaling pathway is associated with poor prognosis in gastroesophageal adenocarcinoma (GEC). We report results of METGastric, a phase 3 trial of the MET inhibitor onartuzumab plus standard first-line chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative, MET-positive, advanced GEC. Objective: To determine whether the addition of onartuzumab to first-line fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) improves efficacy compared with mFOLFOX6 plus placebo in HER2-negative, MET-positive GEC...
December 1, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27916286/relating-therapy-for-distressing-auditory-hallucinations-a-pilot-randomized-controlled-trial
#15
Mark Hayward, Anna-Marie Jones, Leanne Bogen-Johnston, Neil Thomas, Clara Strauss
Auditory hallucinations (AH) are a common and distressing experience and patients report distress reduction to be a priority. Relating Therapy adopts a symptom-specific and mechanism focused approach to the reduction of AH distress. We conducted this single-blind, pragmatic, parallel groups, superiority pilot RCT within a single mental health centre in the UK. Patients (18+years) with persistent and distressing AH, irrespective of diagnosis were randomly allocated to receive either Relating Therapy and Treatment-as-usual (RT) or Treatment as-usual alone (TAU)...
December 1, 2016: Schizophrenia Research
https://www.readbyqxmd.com/read/27914822/effects-of-sodium-thiosulfate-versus-observation-on-development-of-cisplatin-induced-hearing-loss-in-children-with-cancer-accl0431-a-multicentre-randomised-controlled-open-label-phase-3-trial
#16
David R Freyer, Lu Chen, Mark D Krailo, Kristin Knight, Doojduen Villaluna, Bonnie Bliss, Brad H Pollock, Jagadeesh Ramdas, Beverly Lange, David Van Hoff, Michele L VanSoelen, John Wiernikowski, Edward A Neuwelt, Lillian Sung
BACKGROUND: Sodium thiosulfate is an antioxidant shown in preclinical studies in animals to prevent cisplatin-induced hearing loss with timed administration after cisplatin without compromising the antitumour efficacy of cisplatin. The primary aim of this study was to assess sodium thiosulfate for prevention of cisplatin-induced hearing loss in children and adolescents. METHODS: ACCL0431 was a multicentre, randomised, open-label, phase 3 trial that enrolled participants at 38 participating Children's Oncology Group hospitals in the USA and Canada...
November 30, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27914744/persistence-of-bactericidal-antibodies-following-booster-vaccination-with-4cmenb-at-12-18-or-24months-and-immunogenicity-of-a-fifth-dose-administered-at-4years-of-age-a-phase-3-extension-to-a-randomised-controlled-trial
#17
Mildred A Iro, Matthew D Snape, Merryn Voysey, Sena Jawad, Adam Finn, Paul T Heath, Gianni Bona, Susanna Esposito, Javier Diez-Domingo, Roman Prymula, Adefowope Odueyungbo, Daniela Toneatto, Peter Dull, Andrew J Pollard
BACKGROUND: 4CMenB is immunogenic in infants and toddlers. We assessed persistence of human complement serum bactericidal activity (hSBA) following a fourth dose administered at 12, 18 or 24months and characterised the antibody response to a fifth dose administered at 4years of age. METHODS: A phase 3, open label, multi-centre extension to a randomised controlled trial conducted in four countries (number of centres): Czech Republic (nineteen), Italy (four), Spain (four) and the United Kingdom (four)...
November 30, 2016: Vaccine
https://www.readbyqxmd.com/read/27914501/levosimendan-in-patients-with-left-ventricular-systolic-dysfunction-undergoing-cardiac-surgery-on-cardiopulmonary-bypass-rationale-and-study-design-of-the-levosimendan-in-patients-with-left-ventricular-systolic-dysfunction-undergoing-cardiac-surgery-requiring
#18
Rajendra H Mehta, Sean Van Diepen, James Meza, Paula Bokesch, Jeffrey D Leimberger, Sandra Tourt-Uhlig, Merri Swartz, Jodi Parrotta, Rachael Jankowich, Douglas Hay, Robert W Harrison, Stephen Fremes, Shaun G Goodman, John Luber, Wolfgang Toller, Matthias Heringlake, Kevin J Anstrom, Jerrold H Levy, Robert A Harrington, John H Alexander
BACKGROUND: Low cardiac output syndrome is associated with increased mortality and occurs in 3% to 14% of patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). Levosimendan, a novel calcium sensitizer and KATP channel activator with inotropic, vasodilatory, and cardioprotective properties, has shown significant promise in reducing the incidence of low cardiac output syndrome and related adverse outcomes in patients undergoing cardiac surgery on CPB. METHODS: LEVO-CTS is a phase 3 randomized, controlled, multicenter study evaluating the efficacy, safety, and cost-effectiveness of levosimendan in reducing morbidity and mortality in high-risk patients with reduced left ventricular ejection fraction (≤35%) undergoing cardiac surgery on CPB...
December 2016: American Heart Journal
https://www.readbyqxmd.com/read/27914241/engot-ov-6-trinova-2-randomised-double-blind-phase-3-study-of-pegylated-liposomal-doxorubicin-plus-trebananib-or-placebo-in-women-with-recurrent-partially-platinum-sensitive-or-resistant-ovarian-cancer
#19
Christian Marth, Ignace Vergote, Giovanni Scambia, Willi Oberaigner, Andrew Clamp, Regina Berger, Christian Kurzeder, Nicoletta Colombo, Peter Vuylsteke, Domenica Lorusso, Marcia Hall, Vincent Renard, Sandro Pignata, Rebecca Kristeleit, Sevilay Altintas, Gordon Rustin, Robert M Wenham, Mansoor Raza Mirza, Peter C Fong, Amit Oza, Bradley J Monk, Haijun Ma, Florian D Vogl, Bruce A Bach
AIMS: Trebananib, a peptide-Fc fusion protein, inhibits angiogenesis by inhibiting binding of angiopoietin-1/2 to the receptor tyrosine kinase Tie2. This randomised, double-blind, placebo-controlled phase 3 study evaluated whether trebananib plus pegylated liposomal doxorubicin (PLD) improved progression-free survival (PFS) in patients with recurrent epithelial ovarian cancer. METHODS: Women with recurrent ovarian cancer (platinum-free interval ≤12 months) were randomised to intravenous PLD 50 mg/m(2) once every 4 weeks plus weekly intravenous trebananib 15 mg/kg or placebo...
November 30, 2016: European Journal of Cancer
https://www.readbyqxmd.com/read/27913536/reversal-of-direct-oral-anticoagulants-a-practical-approach
#20
Andrew W Shih, Mark A Crowther
Direct oral anticoagulants (DOACs) have at least noninferior efficacy compared with other oral anticoagulants and have ancillary benefits, including overall better safety profiles, lack of the need for routine monitoring, rapid onset of action, and ease of administration. Reversal of these agents may be indicated in certain situations such as severe bleeding and for perioperative management. DOAC-associated bleeding should be risk stratified: patients with moderate or severe bleeding should have the DOAC discontinued and reversal strategies should be considered...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
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