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https://www.readbyqxmd.com/read/29333691/the-innate-immune-system-in-chronic-cardiomyopathy-a-european-society-of-cardiology-esc-scientific-statement-from-the-working-group-on-myocardial-function-of-the-esc
#1
REVIEW
Stefan Frantz, Ines Falcao-Pires, Jean-Luc Balligand, Johann Bauersachs, Dirk Brutsaert, Michele Ciccarelli, Dana Dawson, Leon J de Windt, Mauro Giacca, Nazha Hamdani, Denise Hilfiker-Kleiner, Emilio Hirsch, Adelino Leite-Moreira, Manuel Mayr, Thomas Thum, Carlo G Tocchetti, Jolanda van der Velden, Gilda Varricchi, Stephane Heymans
Activation of the immune system in heart failure (HF) has been recognized for over 20 years. Initially, experimental studies demonstrated a maladaptive role of the immune system. However, several phase III trials failed to show beneficial effects in HF with therapies directed against an immune activation. Preclinical studies today describe positive and negative effects of immune activation in HF. These different effects depend on timing and aetiology of HF. Therefore, herein we give a detailed review on immune mechanisms and their importance for the development of HF with a special focus on commonalities and differences between different forms of cardiomyopathies...
January 15, 2018: European Journal of Heart Failure
https://www.readbyqxmd.com/read/29330636/a-randomised-trial-comparing-the-pharmacokinetics-and-safety-of-the-biosimilar-ct-p6-with-reference-trastuzumab
#2
Francisco J Esteva, Justin Stebbing, Rebecca N Wood-Horrall, Peter J Winkle, Sung Young Lee, Sang Joon Lee
PURPOSE: Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin®) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. METHODS: We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males...
January 12, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29329598/treatment-outcome-of-anti-angiogenesis-through-vegf-pathway-in-the-management-of-gastric-cancer-a-systematic-review-of-phase-ii-and-iii-clinical-trials
#3
Brian Mawalla, Xianglin Yuan, Xiaoxiao Luo, Phillip L Chalya
OBJECTIVES: Advanced gastric cancer poses a therapeutic challenge worldwide. In randomised clinical trials, anti-VEGF has been reported as an essential agent for the treatment of advanced gastric cancer. This review aims at assessing the treatment outcome of anti-angiogenesis therapy through the VEGF pathway in the management of patients with advanced gastric cancer. RESULTS: During this review, 38 clinical trials were identified. Of these, 30 clinical trials were excluded, leaving eight trials of phase II and III...
January 12, 2018: BMC Research Notes
https://www.readbyqxmd.com/read/29328860/quality-of-life-from-canadian-cancer-trials-group-ma-17r-a-randomized-trial-of-extending-adjuvant-letrozole-to-10-years
#4
Julie Lemieux, Michael D Brundage, Wendy R Parulekar, Paul E Goss, James N Ingle, Kathleen I Pritchard, Paul Celano, Hyman Muss, Julie Gralow, Kathrin Strasser-Weippl, Kate Whelan, Dongsheng Tu, Timothy J Whelan
Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months...
January 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29327075/phase-ii-study-of-sorafenib-combined-with-concurrent-hepatic-arterial-infusion-of-oxaliplatin-5-fluorouracil-and-leucovorin-for-unresectable-hepatocellular-carcinoma-with-major-portal-vein-thrombosis
#5
Min-Ke He, Ru-Hai Zou, Qi-Jiong Li, Zhong-Guo Zhou, Jing-Xian Shen, Yong-Fa Zhang, Zi-Shan Yu, Li Xu, Ming Shi
BACKGROUND: Sorafenib is recommended for the first-line treatment of advanced hepatocellular carcinoma (HCC). However, the median progression-free survival (PFS) of patients with HCC and major portal vein tumor thrombosis treated with sorafenib monotherapy is no more than 3 months. A prospective single-arm phase II study was conducted to determine whether adding hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin to sorafenib could improve on these results...
January 11, 2018: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/29326191/establishing-anchor-based-minimally-important-differences-mid-with-the-eortc-quality-of-life-measures-a-meta-analysis-protocol
#6
Zebedee Jammbe Musoro, Jean-Francois Hamel, Divine Ewane Ediebah, Kim Cocks, Madeleine T King, Mogens Groenvold, Mirjam A G Sprangers, Yvonne Brandberg, Galina Velikova, John Maringwa, Hans-Henning Flechtner, Andrew Bottomley, Corneel Coens
INTRODUCTION: As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30)...
January 10, 2018: BMJ Open
https://www.readbyqxmd.com/read/29325469/current-update-of-a-thermosensitive-liposomes-composed-of-dppc-and-brij78
#7
Laurence Ho, Mehrdad Bokharaei, Shyh-Dar Li
Thermosensitive liposomes (TSLs) have been a prominent area of study in the discipline of tumor-targeted chemotherapeutics. The representative product of TSLs is ThermoDox® (DPPC/lyso-PC/PEG-lipid), which has advanced to Phase III clinical trials. Various groups have sought to develop a new TSL to improve upon the LTSL (lyso-lipid temperature sensitive liposomes) formulation that is used to prepare ThermoDOX®. This review focuses on the development and recent update of an innovative TSL formulation, HaT-liposomes composed of DPPC and Brij78...
January 11, 2018: Journal of Drug Targeting
https://www.readbyqxmd.com/read/29324972/prognostic-and-predictive-role-of-neutrophil-lymphocytes-ratio-in-metastatic-colorectal-cancer-a-retrospective-analysis-of-the-tribe-study-by-gono
#8
E Dell'Aquila, C Cremolini, T Zeppola, S Lonardi, F Bergamo, G Masi, M Stellato, F Marmorino, M Schirripa, F Urbano, M Ronzoni, G Tomasello, A Zaniboni, P Racca, A Buonadonna, G Allegrini, E Fea, S Di Donato, S Chiara, G Tonini, D Tomcikova, L Boni, A Falcone, D Santini
Background: Neutrophil/Lymphocyte ratio (NLR), defined as absolute neutrophils count divided by absolute lymphocytes count, has been reported as poor prognostic factor in several neoplastic diseases but only a few data are available about unresectable metastatic colorectal cancer (mCRC) patients (pts). The aim of our study was to evaluate the prognostic and predictive role of NLR in the TRIBE trial. Patients and Methods: Pts enrolled in TRIBE trial were included...
January 8, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29323175/functional-antibody-response-against-v1v2-and-v3-of-hiv-gp120-in-the-vax003-and-vax004-vaccine-trials
#9
Preetha Balasubramanian, Constance Williams, Mariya B Shapiro, Faruk Sinangil, Keith Higgins, Arthur Nádas, Maxim Totrov, Xiang-Peng Kong, Andrew J Fiore-Gartland, Nancy L Haigwood, Susan Zolla-Pazner, Catarina E Hioe
Immunization with HIV AIDSVAX gp120 vaccines in the phase III VAX003 and VAX004 trials did not confer protection. To understand the shortcomings in antibody (Ab) responses induced by these vaccines, we evaluated the kinetics of Ab responses to the V1V2 and V3 regions of gp120 and the induction of Ab-mediated antiviral functions during the course of 7 vaccinations over a 30.5-month period. Plasma samples from VAX003 and VAX004 vaccinees and placebo recipients were measured for ELISA-binding Abs and for virus neutralization, Ab-dependent cellular phagocytosis (ADCP), and Ab-dependent cellular cytotoxicity (ADCC)...
January 11, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29320580/detection-of-fast-oscillating-magnetic-fields-using-dynamic-multiple-tr-imaging-and-fourier-analysis
#10
Ki Hwan Kim, Hyo-Im Heo, Sung-Hong Park
Neuronal oscillations produce oscillating magnetic fields. There have been trials to detect neuronal oscillations using MRI, but the detectability in in vivo is still in debate. Major obstacles to detecting neuronal oscillations are (i) weak amplitudes, (ii) fast oscillations, which are faster than MRI temporal resolution, and (iii) random frequencies and on/off intervals. In this study, we proposed a new approach for direct detection of weak and fast oscillating magnetic fields. The approach consists of (i) dynamic acquisitions using multiple times to repeats (TRs) and (ii) an expanded frequency spectral analysis...
2018: PloS One
https://www.readbyqxmd.com/read/29318751/subgroup-analysis-of-east-asian-patients-in-regard-a-phase-iii-trial-of-ramucirumab-and-best-supportive-care-for-advanced-gastric-cancer
#11
Hyun Cheol Chung, Victor C Kok, Rebecca Cheng, Yanzhi Hsu, Mauro Orlando, Charles Fuchs, Jae Yong Cho
AIM: We describe a subgroup analysis assessing the efficacy and safety of ramucirumab monotherapy in East Asian (EA) patients from the REGARD trial. METHODS: Patients with advanced gastric or gastroesophageal junction adenocarcinoma with progressive disease were randomized 2:1 to receive ramucirumab (8 mg/kg) plus best supportive care (BSC) or placebo plus BSC every 2 weeks. Post hoc subset analyses were performed on the EA and non-EA intention-to-treat populations...
January 10, 2018: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29318022/clinical-trial-experience-with-ca4p-anticancer-therapy-focus-on-efficacy-cardiovascular-adverse-events-and-hypertension-management
#12
REVIEW
Rachel Grisham, Bonnie Ky, Krishnansu S Tewari, David J Chaplin, Joan Walker
Combretastatin A4-phosphate (CA4P) is a vascular-disrupting agent (VDA) in clinical development for the treatment of ovarian and other cancers. In contrast to antiangiogenic agents, such as bevacizumab, which suppress the development of new tumor vasculature, VDAs target established tumor vasculature. These differing but complementary mechanisms of action are currently being explored in clinical trials combining CA4P and bevacizumab. Clinical experience to date has highlighted an important need to better understand the cardiovascular adverse events of CA4P, both alone and in combination with antiangiogenic agents, which can also be associated with cardiovascular adverse events...
2018: Gynecologic Oncology Research and Practice
https://www.readbyqxmd.com/read/29317823/european-perspective-on-the-management-of-rheumatoid-arthritis-clinical-utility-of-tofacitinib
#13
REVIEW
Paweł Kawalec, Katarzyna Śladowska, Iwona Malinowska-Lipień, Tomasz Brzostek, Maria Kózka
Xeljanz® (tofacitinib) is an oral small-molecule inhibitor that reversibly inhibits Janus-activated kinase (JAK)-dependent cytokine signaling, thus reducing inflammation. As a result of these mechanisms, effects on the immune system such as a moderate decrease in the total lymphocyte count, a dose-dependent decrease in natural killer (NK) cell count, and an increase in B-cell count have been observed. Therefore, tofacitinib provides an innovative approach to modulating the immune and inflammatory responses in patients with rheumatoid arthritis (RA), which is especially important in individuals who do not respond to tumor necrosis factor inhibitors or show a loss of response over time...
2018: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/29317553/safety-profile-of-biosimilar-filgrastim-zarzio-zarxio-a-combined-analysis-of-phase-iii-studies
#14
Nadia Harbeck, Pere Gascón, Andriy Krendyukov, Nadja Hoebel, Sreekanth Gattu, Kimberly Blackwell
BACKGROUND: Evaluation of adverse events (AEs) in pivotal registration trials and ongoing postmarketing surveillance is important for all biologics, including biosimilars. A combined analysis of two pivotal registration studies was performed to strengthen evidence on safety for biosimilar filgrastim EP2006 in patients with breast cancer receiving myelosuppressive chemotherapy, a sensitive clinical setting to confirm biosimilarity of filgrastim. MATERIALS AND METHODS: Data were combined from two phase III studies of biosimilar filgrastim EP2006...
January 9, 2018: Oncologist
https://www.readbyqxmd.com/read/29317395/the-role-of-elotuzumab-in-the-treatment-of-relapsed-or-refractory-multiple-myeloma
#15
REVIEW
Jill M Comeau, Katherine Kelly, Gary W Jean
PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy and safety, cost, and place in therapy of elotuzumab for treatment of relapsed or refractory multiple myeloma (MM) are reviewed. SUMMARY: Elotuzumab is a humanized monoclonal antibody that targets the signaling lymphocytic activation molecule (SLAM) protein SLAMF7 and facilitates an antibody-dependent cellular cytotoxicity interaction between myeloma cells and natural killer cells. Elotuzumab has U.S...
January 15, 2018: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/29317015/randomized-trial-to-assess-the-efficacy-and-safety-of-beclomethasone-dipropionate-breath-actuated-inhaler-in-patients-with-asthma
#16
(no author information available yet)
BACKGROUND: Breath-actuated inhalers (BAI) eliminate the need for the hand-breath coordination required with standardmetered-dose inhalers (MDI). OBJECTIVE: To evaluate the efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI. METHODS: This 6-week, phase III, double-blind study included patients aged greater than or equal to 12 years with persistent asthma. During the single-blind run-in, patients discontinued asthma medications and received twice-daily placebo BAI or MDI...
January 9, 2018: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/29316962/hopon-hyperbaric-oxygen-for-the-prevention-of-osteoradionecrosis-a-randomised-controlled-trial-of-hyperbaric-oxygen-to-prevent-osteoradionecrosis-of-the-irradiated-mandible-study-protocol-for-a-randomised-controlled-trial
#17
Richard Shaw, Christopher Butterworth, Binyam Tesfaye, Matthew Bickerstaff, Susanna Dodd, Gary Smerdon, Seema Chauhan, Peter Brennan, Keith Webster, James McCaul, Peter Nixon, Anastasios Kanatas, Paul Silcocks
BACKGROUND: Osteoradionecrosis of the mandible is the most common serious complication of radiotherapy for head and neck malignancy. For decades, hyperbaric oxygen has been employed in efforts to prevent those cases of osteoradionecrosis that are precipitated by dental extractions or implant placement. The evidence for using hyperbaric oxygen remains poor and current clinical practice varies greatly. We describe a protocol for a clinical trial to assess the benefit of hyperbaric oxygen in the prevention of osteoradionecrosis during surgery on the irradiated mandible...
January 10, 2018: Trials
https://www.readbyqxmd.com/read/29316837/ruxolitinib-for-the-treatment-of-patients-with-steroid-refractory-gvhd-an-introduction-to-the-reach-trials
#18
Madan Jagasia, Robert Zeiser, Michael Arbushites, Patricia Delaite, Brian Gadbaw, Nikolas von Bubnoff
For patients with hematologic malignancies and disorders, allogeneic hematopoietic stem cell transplantation offers a potentially curative treatment option. Many patients develop graft-versus-host disease (GVHD), a serious complication and leading cause of nonrelapse mortality. Corticosteroids are the standard first-line treatment for GVHD; however, patients often become steroid-refractory or remain corticosteroid-dependent. New second-line treatment options are needed to improve patient outcomes. Here we review the role of JAK1 and JAK2 in acute and chronic GVHD...
January 10, 2018: Immunotherapy
https://www.readbyqxmd.com/read/29316335/exposure-response-model-of-subcutaneous-c1-inhibitor-concentrate-to-estimate-the-risk-of-attacks-in-patients-with-hereditary-angioedema
#19
Ying Zhang, Michael A Tortorici, Dipti Pawaskar, Ingo Pragst, Thomas Machnig, Matthew Hutmacher, Bruce Zuraw, Marco Cicardi, Timothy Craig, Hilary Longhurst, Jagdev Sidhu
Subcutaneous C1-inhibitor (HAEGARDA, CSL Behring), is a US Food and Drug Administration (FDA)-approved, highly concentrated formulation of a plasma-derived C1-esterase inhibitor (C1-INH), which, in the phase III Clinical Studies for Optimal Management in Preventing Angioedema with Low-Volume Subcutaneous C1-inhibitor Replacement Therapy (COMPACT) trial, reduced the incidence of hereditary angioedema (HAE) attacks when given prophylactically. Data from the COMPACT trial were used to develop a repeated time-to-event model to characterize the timing and frequency of HAE attacks as a function of C1-INH activity, and then develop an exposure-response model to assess the relationship between C1-INH functional activity levels (C1-INH(f)) and the risk of an attack...
January 9, 2018: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/29315999/long-term-safety-and-efficacy-of-acotiamide-in-functional-dyspepsia-postprandial-distress-syndrome-results-from-the-european-phase-3-open-label-safety-trial
#20
J Tack, J Pokrotnieks, G Urbonas, C Banciu, V Yakusevich, I Bunganic, H Törnblom, Y Kleban, P Eavis, M Tsuchikawa, T Miyagawa
BACKGROUNDS: Acotiamide is a novel acetylcholinesterase inhibitor for treatment of postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). This European phase 3 open-label safety trial has been conducted to evaluate the long-term safety of acotiamide and explore the efficacy of acotiamide on PDS symptoms using the validated LPDS, quality of life using SF-36 and SF-NDI, and work productivity using WPAI. METHODS: FD-PDS patients (defined by ROME III criteria) aged ≥18 years with active PDS symptoms and without predominant overlapping symptoms of epigastric pain syndrome and related disorders were enrolled to receive 100 mg acotiamide three times daily for 1 year...
January 8, 2018: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
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