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https://www.readbyqxmd.com/read/28937327/carfilzomib-dexamethasone-versus-subcutaneous-or-intravenous-bortezomib-in-relapsed-or-refractory-multiple-myeloma-secondary-analysis-of-the-phase-3-endeavor-study
#1
Hartmut Goldschmidt, Philippe Moreau, Heinz Ludwig, Ruben Niesvizky, Wee-Joo Chng, Douglas Joshua, Katja Weisel, Andrew Spencer, Robert Z Orlowski, Shibao Feng, Karim S Iskander, Meletios A Dimopoulos
This is a secondary analysis of the phase 3 ENDEAVOR study comparing relapsed and/or refractory multiple myeloma (RRMM) patients receiving carfilzomib-dexamethasone (Kd) with those receiving subcutaneous (SC) bortezomib with dexamethasone (Vd) or intravenous (IV) Vd. Of Kd-treated patients, 356 Kd were pre-selected (by physician prior to randomization if to be randomized to Vd) for SC Vd (Kd [SC Vd]) and 108 for IV Vd (Kd [IV Vd], respectively. Of Vd-treated patients, 360 received SC Vd and 75 IV Vd. Kd (SC Vd) median PFS was not reached; SC Vd was 9...
September 22, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28936569/treatment-related-serious-adverse-events-and-fatal-adverse-events-with-regorafenib-in-cancer-patients-a-meta-analysis-of-phase-3-randomized-controlled-trials
#2
REVIEW
Meihui Cao, Feifei Li, Yue Wang, Jingdong Zhang
Regorafenib (Stivarga) is an oral small-molecule multikinase inhibitor commonly used against a variety of cancers. We performed a meta-analysis of all phase 3 randomized controlled trials (RCTs) of regorafenib to quantify the increased risk of SAEs and FAEs. We carried out a systematic search of electronic databases for studies published from inception to February 2017 without any restrictions. Eligibility criteria included phase 3 RCTs of tumors comparing regorafenib, alone or in combination with non-targeted chemotherapy (regorafenib arm) versus placebo or non-targeted chemotherapy (control arm)...
September 22, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28935847/cd56bright-nk-regulatory-cells-in-filgrastim-primed-donor-blood-or-marrow-products-regulate-chronic-gvhd-cbmtg-randomized-0601-study-results
#3
Amina Kariminia, Sabine Ivison, Bernard Ng, Jacob Rozmus, Susanna Sung, Avani Varshney, Mahmoud Aljurf, Silvy Lachance, Irwin Walker, Cindy Toze, Jeff Lipton, Stephanie J Lee, Jeff Szer, Richard Doocey, Ian Lewis, Clayton Smith, Naeen Chaudhri, Megan K Levings, Raewyn Broady, Gerald Devins, David Szwajcer, Ronan Foley, Sara Mostafavi, Steven Pavletic, Donna A Wall, Stephen Couban, Tony Panzarella, Kirk R Schultz
Randomized trials have conclusively shown higher rates of chronic graft-versus-host disease with filgrastim-stimulated apheresis peripheral blood as a donor source than unstimulated bone marrow. The Canadian Blood and Marrow Transplant Group conducted a phase 3 study of adults who received either filgrastim-stimulated apheresis peripheral blood or filgrastim-stimulated bone marrow from human leukocyte antigen-identical sibling donors. Because all donors received the identical filgrastim dosing schedule, this study allowed for a controlled evaluation of the impact of stem cell source on development of chronic graft-versus-host disease...
September 21, 2017: Haematologica
https://www.readbyqxmd.com/read/28934023/biomarker-enrichment-considerations-in-oncology-early-development-single-arm-studies
#4
Hong Tian, Kevin Liu
Oncology drug development has been increasingly shaped by molecularly targeted agents (MTAs), which often demonstrate differential effectiveness driven by the biomarker expression levels on tumors. Innovative statistical designs have been proposed to tackle this challenge, e.g., Freidlin et al (2005), Jiang et al (2007) and Freidlin et al (2010). All of these are essentially adaptive confirmatory Phase 3 designs that combine the testing of treatment effectiveness in the overall population with an alternative pathway for a more restrictive efficacy claim in a sensitive subpopulation...
September 21, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28933517/new-treatment-modalities-for-neovascular-age-related-macular-degeneration
#5
Patricio G Schlottmann, Arturo A Alezzandrini, Marcelo Zas, Francisco J Rodriguez, José D Luna, Lihteh Wu
Age-related macular degeneration (AMD) is considered one of the main causes of severe vision loss in older adults. The neovascular form (nAMD) is an advanced stage, which is responsible for the most severe vision loss. Vascular endothelial growth factor (VEGF) is at present the main factor that leads to the development of a neovascular membrane and the increased leakage from the membrane to the retina. At present, anti-VEGF therapy is the only treatment that achieves vision gains in many patients and halts progression in most of them...
September 14, 2017: Asia-Pacific Journal of Ophthalmology
https://www.readbyqxmd.com/read/28932633/cd163-positive-tumor-associated-macrophages-and-cd8-positive-cytotoxic-lymphocytes-are-powerful-diagnostic-markers-for-the-therapeutic-stratification-of-osteosarcoma-patients-an-immunohistochemical-analysis-of-the-biopsies-fromthe-french-os2006-phase-3-trial
#6
Anne Gomez-Brouchet, Claire Illac, Julia Gilhodes, Corinne Bouvier, Sébastien Aubert, Jean-Marc Guinebretiere, Béatrice Marie, Frédérique Larousserie, Natacha Entz-Werlé, Gonzague de Pinieux, Thomas Filleron, Véronique Minard, Vincent Minville, Eric Mascard, François Gouin, Marta Jimenez, Marie-Cécile Ledeley, Sophie Piperno-Neumann, Laurence Brugieres, Françoise Rédini
The French phase 3 trial (OS 2006) testing zoledronic acid, an osteoclast inhibitor, with chemotherapy and surgery did not improve the outcome of patients with osteosarcoma (OS). To understand this unexpected result, the presence of infiltrating immune cells was investigated in 124 pre-therapeutic biopsies of patients enrolled in the trial. The percentage of CD68/CD163 tumor-infiltrating macrophages (TAMs), CD8(+) lymphocytes, osteoclasts, and the PD1/PDL-1 checkpoint were assessed by immunohistochemistry. M1/M2 macrophage polarization was characterized by pSTAT1/CMAF staining...
2017: Oncoimmunology
https://www.readbyqxmd.com/read/28930917/shock-2017-military-supplement-an-overview-of-two-human-trials-of-perfluorocarbon-emulsions-in-non-cardiac-surgery
#7
Donat R Spahn, Peter E Keipert
Perfluorochemicals (PFCs) constitute one class of artificial oxygen carriers that are being produced completely synthetically. One formulation that has been evaluated extensively in clinical trials is a 60% w/v perflubron-based emulsion. Efficacy and safety of this perflubron emulsion was evaluated in a Phase 2 and a large prospective randomized Phase 3 multicenter European study, which collectively included a total of 639 patients. Perflubron emulsion was highly successful in improving organ function, reversing physiologic transfusion triggers and in reducing the need for allogeneic blood transfusions...
September 19, 2017: Shock
https://www.readbyqxmd.com/read/28928122/discovery-and-preclinical-characterization-of-gsk1278863-daprodustat-a-small-molecule-hypoxia-inducible-factor-hif-prolyl-hydroxylase-inhibitor-for-anemia
#8
Jennifer L Ariazi, Kevin J Duffy, David F Adams, Duke M Fitch, Lusong Luo, Melissa Pappalardi, Mangatt Biju, Erin Hugger DiFilippo, Tony Shaw, Ken Wiggall, Connie Erickson-Miller
Decreased erythropoietin (EPO) production, shortened erythrocyte survival, and other factors reducing the response to EPO contribute to anemia in patients with a variety of underlying pathologies such as chronic kidney disease (CKD). Treatment with recombinant human EPO (rHuEPO) at supraphysiological concentrations has proven to be efficacious. However, it does not ameliorate the condition in all patients and presents its own risks, including cardiovascular complications. The transcription factors hypoxia-inducible factor (HIF)1α and HIF2α control the physiological response to hypoxia and invoke a program of increased erythropoeisis...
September 19, 2017: Journal of Pharmacology and Experimental Therapeutics
https://www.readbyqxmd.com/read/28927890/reduction-of-inflammatory-and-cardiovascular-proteins-in-the-blood-of-psoriasis-patients-differential-responses-between-tofacitinib-and-etanercept-after-4-weeks-of-treatment
#9
Jaehwan Kim, Lewis Tomalin, Julie Lee, Lori J Fitz, Gabriel Berstein, Joel Correa-da Rosa, Sandra Garcet, Michelle A Lowes, Hernan Valdez, Robert Wolk, Mayte Suarez-Farinas, James G Krueger
Psoriasis patients have increased risk of myocardial infarction, and psoriasis is now recognized as an independent risk factor for coronary heart disease and cardiovascular mortality. To understand the effects of psoriasis medications on systemic inflammation associated with cardiovascular risks, we studied blood proteins related to inflammation and cardiovascular disease archived from a phase 3 clinical trial of tofacitinib and etanercept in adults with moderate-to-severe psoriasis. 157 blood proteins were quantified by a proximity extension assay from 266 patients at baseline and week 4...
September 16, 2017: Journal of Investigative Dermatology
https://www.readbyqxmd.com/read/28927227/enteric-microbiome-profiles-during-a-randomized-phase-2-clinical-trial-of-surotomycin-versus-vancomycin-for-the-treatment-of-clostridium-difficile-infection
#10
Kristine Cannon, Brendan Byrne, Jennifer Happe, Kaiyu Wu, Linda Ward, Laurent Chesnel, Thomas Louie
Objectives: The effects of surotomycin (CB-183,315, MK-4261), a bactericidal cyclic lipopeptide, and vancomycin, the current standard-of-care for Clostridium difficile infection (CDI), on intestinal pathogens and microbiota were evaluated parallel to a Phase 2 randomized, double-blind clinical trial. Methods: The single-centre cohort included 26 patients receiving surotomycin [125 or 250 mg twice daily ( n  =   9 each)] or oral vancomycin [125 mg four times daily ( n  =   8)] for 10 days...
September 12, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28926514/a-randomized-multicenter-double-blind-study-to-evaluate-the-safety-and-efficacy-of-estradiol-vaginal-cream-0-003-in-postmenopausal-women-with-dyspareunia-as-the-most-bothersome-symptom
#11
Robin Kroll, David F Archer, Yuhua Lin, Vilma Sniukiene, James H Liu
OBJECTIVE: Vulvovaginal atrophy (VVA) is characterized by vaginal changes, dyspareunia, and itching/irritation. Efficacy and safety of a lower-dose estradiol vaginal cream (0.003%) were evaluated in postmenopausal women with VVA-related dyspareunia. METHODS: This was a phase 3, randomized, double-blind, placebo-controlled study. Sexually active postmenopausal women with moderate-severe dyspareunia as the most bothersome symptom, ≤5% vaginal superficial cells, and vaginal pH >5...
September 18, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28926295/efficacy-and-safety-assessment-of-acute-sports-related-traumatic-soft-tissue-injuries-using-a-new-ibuprofen-medicated-plaster-results-from-a-randomized-controlled-clinical-trial
#12
Hans-Georg Predel, Mark P Connolly, Aomesh Bhatt, Bruno Giannetti
OBJECTIVE: To investigate the efficacy and safety of a recently developed ibuprofen medicated plaster in the treatment of acute sports impact injuries/contusions. METHODS: In this double-blind, multi-center, placebo-controlled, parallel group, phase 3 study (EudraCT Number: 2012-003257-2) patients (n=132; ages 18 to 60 years) diagnosed with acute sports-related traumatic blunt soft tissue injury/contusion to the upper or lower limbs were randomized to receive either ibuprofen 200 mg plaster (n=64) or placebo plaster (n=68)...
September 19, 2017: Physician and Sportsmedicine
https://www.readbyqxmd.com/read/28926170/efficacy-and-safety-of-saxagliptin-in-combination-with-metformin-as-initial-therapy-in-chinese-patients-with-type-2-diabetes-results-from-the-start-study-a-multicenter-randomized-double-blind-active-controlled-phase-3-trial
#13
Jingtao Dou, Jianhua Ma, Jun Liu, Changjiang Wang, Eva Johnsson, Hui Yao, June Zhao, Changyu Pan
OBJECTIVE: To assess the efficacy and safety of saxagliptin plus metformin over 24 weeks in pharmacotherapy-naïve Chinese patients with type 2 diabetes mellitus and inadequate glycemic control (HbA1c 8.0-12.0%). RESEARCH DESIGN AND METHODS: In this multicenter, double-blind, active-controlled study (The START study: NCT02273050), patients were randomized (1:1:1) to saxagliptin 5 mg plus metformin, saxagliptin 5 mg plus placebo, or metformin plus placebo. Saxagliptin was taken once daily; metformin was taken once/twice daily and was titrated from 500 mg to a maximum of 2000 mg/day over 8 weeks...
September 19, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28926120/glecaprevir-pibrentasvir-for-hcv-genotype-3-patients-with-cirrhosis-and-or-prior-treatment-experience-a-partially-randomized-phase-iii-clinical-trial
#14
David Wyles, Fred Poordad, Stanley Wang, Laurent Alric, Franco Felizarta, Paul Y Kwo, Benedict Maliakkal, Kosh Agarwal, Tarek Hassanein, Frank Weilert, Samuel S Lee, Jens Kort, Sandra S Lovell, Ran Liu, Chih-Wei Lin, Tami Pilot-Matias, Preethi Krishnan, Federico J Mensa
BACKGROUND: This study assessed the efficacy and safety of ribavirin (RBV)-free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus (HCV) genotype (GT) 3 infection with either prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. METHODS: SURVEYOR-II, Part 3 was a partially-randomized, open-label, multicenter, phase 3 study. Treatment-experienced (prior interferon (IFN) or pegIFN ± ribavirin or SOF plus ribavirin ± pegIFN therapy) patients without cirrhosis were randomized 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily...
September 19, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28926095/model-based-assessment-using-conventional-bioequivalence-limits-to-ensure-safety-and-efficacy-of-rivaroxaban-in-patients-undergoing-hip-or-knee-replacement
#15
Mario González-Sales, Lanyan Fang, Myong-Jin Kim, Liang Zhao
We evaluated whether the current bioequivalence limit is adequate to ensure safety and efficacy of rivaroxaban in patients under total hip arthroplasty and total knee arthroplasty based on its model informed benefit/risk profile. Clinical data from a total of 7145 patients from 3 phase 2 and 4 phase 3 clinical trials were included in the current model-based exposure-response analysis. The relationships between rivaroxaban exposure measurements (ie, minimum or trough, maximum, average concentration, and area under the concentration-time curve [AUC] at steady state) and clinical outcomes (ie, the probabilities of major bleeding [MB] and venous thromboembolism [VTE]) were modeled using NONMEM 7...
September 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28923526/results-of-a-double-blind-randomized-placebo-controlled-study-of-nabiximols-oromucosal-spray-as-adjunctive-therapy-in-advanced-cancer-patients-with-chronic-uncontrolled-pain
#16
Aron H Lichtman, Eberhard Albert Lux, Robert McQuade, Sandro Rossetti, Raymond Sanchez, Wei Sun, Stephen Wright, Elena Kornyeyeva, Marie T Fallon
CONTEXT: Prior phase 2/3 studies found that cannabinoids might provide adjunctive analgesia in advanced cancer patients with uncontrolled pain. OBJECTIVE: To assess adjunctive nabiximols (Sativex(®)), an extract of Cannabis sativa containing two potentially therapeutic cannabinoids (Δ9-tetrahydrocannabinol [27 mg/mL] and cannabidiol [25mg/mL]), in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy. METHODS: Phase 3, double-blind, randomized, placebo-controlled trial in patients with advanced cancer and average pain NRS scores ≥ 4 and ≤ 8 despite optimized opioid therapy...
September 15, 2017: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/28923101/durable-response-rate-as-an-endpoint-in-cancer-immunotherapy-insights-from-oncolytic-virus-clinical-trials
#17
Howard L Kaufman, Robert H I Andtbacka, Frances A Collichio, Michael Wolf, Zhongyun Zhao, Mark Shilkrut, Igor Puzanov, Merrick Ross
BACKGROUND: Traditional response criteria may be insufficient to characterize full clinical benefits of anticancer immunotherapies. Consequently, endpoints such as durable response rate (DRR; a continuous response [complete or partial objective response] beginning within 12 months of treatment and lasting ≥6 months) have been employed. There has not, however, been validation that DRR correlates with other more traditional endpoints of clinical benefit such as overall survival. METHODS: We evaluated whether DRR was associated with clinically meaningful measures of benefit (eg, overall survival [OS], quality of life [QoL], or treatment-free interval [TFI]) in a phase 3 clinical trial of an oncolytic virus for melanoma treatment...
September 19, 2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28921915/weekly-glucagon-like-peptide-1-receptor-agonist-albiglutide-as-monotherapy-improves-glycemic-parameters-in-japanese-patients-with-type-2-diabetes-mellitus-a-randomized-double-blind-placebo-controlled-study
#18
Antonio Nino, Inaha Okuda, Timothy H Wilson, Lin Yue, Hiromu Nakajima, Maho Tsuboi, Molly C Carr, Yutaka Seino
AIMS/INTRODUCTION: This phase 3, randomized, double-blind 24-week study with extension to 1 year assessed efficacy and safety of albiglutide compared with placebo in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise with or without a single oral antidiabetic drug. MATERIALS AND METHODS: Patients received weekly albiglutide 30 mg (n=160), albiglutide 50 mg (n=150), or placebo switched to albiglutide 30 mg after 24 weeks (n=77)...
September 16, 2017: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28919712/recent-developments-in-the-clinical-pharmacology-of-rolapitant-subanalyses-in-specific-populations
#19
REVIEW
Bernardo Leon Rapoport, Matti Aapro, Martin R Chasen, Karin Jordan, Rudolph M Navari, Ian Schnadig, Lee Schwartzberg
Knowledge of the involvement of the neurokinin substance P in emesis has led to the development of the neurokinin-1 receptor antagonists (NK-1 RAs) for control of chemotherapy-induced nausea and vomiting (CINV), in combination with serotonin type 3 receptor antagonists and corticosteroids. The NK-1 RA rolapitant, recently approved in oral formulation, has nanomolar affinity for the NK-1 receptor, as do the other commercially available NK-1 RAs, aprepitant and netupitant. Rolapitant is rapidly absorbed and has a long half-life in comparison to aprepitant and netupitant...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28919200/predictors-of-enhanced-response-with-benralizumab-for-patients-with-severe-asthma-pooled-analysis-of-the-sirocco-and-calima-studies
#20
J Mark FitzGerald, Eugene R Bleecker, Andrew Menzies-Gow, James G Zangrilli, Ian Hirsch, Paul Metcalfe, Paul Newbold, Mitchell Goldman
BACKGROUND: Benralizumab is an anti-eosinophilic, anti-interleukin-5 receptor α monoclonal antibody that has been shown to significantly reduce asthma exacerbations and improve lung function for patients with severe, uncontrolled asthma. We further explored the efficacy of benralizumab for patients with different baseline blood eosinophil thresholds and exacerbation histories. METHODS: This study is a pooled analysis of the results from the randomised, double-blind, placebo-controlled SIROCCO (NCT01928771) and CALIMA (NCT01914757) phase 3 studies...
September 8, 2017: Lancet Respiratory Medicine
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