keyword
MENU ▼
Read by QxMD icon Read
search

phase 1 trial

keyword
https://www.readbyqxmd.com/read/29444376/secukinumab-demonstrates-high-sustained-efficacy-and-a-favorable-safety-profile-in-patients-with-moderate-to-severe-psoriasis-through-5-years-of-treatment-sculpture-extension-study
#1
R Bissonnette, T Luger, D Thaçi, D Toth, A Lacombe, S Xia, R Mazur, M Patekar, P Charef, M Milutinovic, C Leonardi, U Mrowietz
BACKGROUND: Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has been shown to have significant efficacy and a favorable safety profile in the treatment of moderate to severe psoriasis and psoriatic arthritis. OBJECTIVE: To assess the efficacy and safety of secukinumab through 5 years of treatment in moderate to severe psoriasis. METHODS: In the core SCULPTURE study, Psoriasis Area and Severity Index (PASI) 75 responders at Week 12 continued receiving subcutaneous secukinumab until Year 1...
February 14, 2018: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/29444231/phase-iia-study-of-the-cd19-antibody-mor208-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-s-lymphoma
#2
W Jurczak, P L Zinzani, G Gaidano, A Goy, M Provencio, Z Nagy, T Robak, K Maddocks, C Buske, S Ambarkhane, M Winderlich, M Dirnberger-Hertweck, R Korolkiewicz, K A Blum
Background: This two-stage, phase IIa study (ClinicalTrials.gov: NCT01685008) investigated the antitumor activity and safety of MOR208, an Fc-engineered, humanized, CD19 antibody, in patients with relapsed or refractory (R-R) B-cell non-Hodgkin's lymphoma (NHL). CD19 is broadly expressed across the B-lymphocyte lineage, including in B-cell malignancies, but not by hematological stem cells. Patients and methods: Patients aged ≥18 years, with R-R NHL progressing after ≥1 prior rituximab containing regimen were enrolled into subtype-specific cohorts: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), other indolent (i)NHL and mantle cell lymphoma (MCL)...
February 9, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29443664/nusinersen-versus-sham-control-in-later-onset-spinal-muscular-atrophy
#3
Eugenio Mercuri, Basil T Darras, Claudia A Chiriboga, John W Day, Craig Campbell, Anne M Connolly, Susan T Iannaccone, Janbernd Kirschner, Nancy L Kuntz, Kayoko Saito, Perry B Shieh, Már Tulinius, Elena S Mazzone, Jacqueline Montes, Kathie M Bishop, Qingqing Yang, Richard Foster, Sarah Gheuens, C Frank Bennett, Wildon Farwell, Eugene Schneider, Darryl C De Vivo, Richard S Finkel
BACKGROUND: Nusinersen is an antisense oligonucleotide drug that modulates pre-messenger RNA splicing of the survival motor neuron 2 ( SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). METHODS: We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2:1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274...
February 15, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29440868/ocular-comfort-assessment-of-lifitegrast-ophthalmic-solution-5-0-in-opus-3-a-phase-iii-randomized-controlled-trial
#4
Kelly K Nichols, Edward Holland, Melissa M Toyos, James H Peace, Parag Majmudar, Aparna Raychaudhuri, Mohamed Hamdani, Monica Roy, Amir Shojaei
Purpose: To evaluate ocular comfort of lifitegrast ophthalmic solution 5.0% among patients with dry eye disease (DED) in the OPUS-3 trial. Methods: OPUS-3 was a multicenter, randomized, double-masked, placebo-controlled study. Adults with DED and recent artificial tear use were randomized 1:1 (lifitegrast:placebo) to ophthalmic drops twice daily for 84 days. On days 0 (baseline), 14, 42, and 84, drop comfort score (scale, 0-10; 0 = very comfortable, 10 = very uncomfortable) was measured at 0, 1, 2, and 3 minutes postinstillation...
2018: Clinical Ophthalmology
https://www.readbyqxmd.com/read/29439857/axitinib-in-combination-with-pembrolizumab-in-patients-with-advanced-renal-cell-cancer-a-non-randomised-open-label-dose-finding-and-dose-expansion-phase-1b-trial
#5
Michael B Atkins, Elizabeth R Plimack, Igor Puzanov, Mayer N Fishman, David F McDermott, Daniel C Cho, Ulka Vaishampayan, Saby George, Thomas E Olencki, Jamal C Tarazi, Brad Rosbrook, Kathrine C Fernandez, Mariajose Lechuga, Toni K Choueiri
BACKGROUND: Previous studies combining PD-1 checkpoint inhibitors with tyrosine kinase inhibitors of the VEGF pathway have been characterised by excess toxicity, precluding further development. We hypothesised that axitinib, a more selective VEGF inhibitor than others previously tested, could be combined safely with pembrolizumab (anti-PD-1) and yield antitumour activity in patients with treatment-naive advanced renal cell carcinoma. METHODS: In this ongoing, open-label, phase 1b study, which was done at ten centres in the USA, we enrolled patients aged 18 years or older who had advanced renal cell carcinoma (predominantly clear cell subtype) with their primary tumour resected, and at least one measureable lesion, Eastern Cooperative Oncology Group performance status 0-1, controlled hypertension, and no previous systemic therapy for renal cell carcinoma...
February 9, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29439671/treatment-using-oxaliplatin-and-s-1-adjuvant-chemotherapy-for-pathological-stage-iii-gastric-cancer-a-multicenter-phase-ii-study-tosa-trial-protocol
#6
Tsutomu Namikawa, Hiromichi Maeda, Hiroyuki Kitagawa, Koji Oba, Akihito Tsuji, Takaki Yoshikawa, Michiya Kobayashi, Kazuhiro Hanazaki
BACKGROUND: Recent studies demonstrated the efficacy of S-1-based adjuvant chemotherapy administered for six months after curative surgery for stage III gastric cancer; however, it is unproven whether this type of combination chemotherapy is more effective than the standard adjuvant chemotherapy of S-1 for one year. METHODS: This multicenter phase II study evaluate the efficacy and safety of adjuvant chemotherapy using S-1 plus oxaliplatin followed by S-1 for up to one year for curatively resected stage III gastric cancer in patients aged over 20 years...
February 13, 2018: BMC Cancer
https://www.readbyqxmd.com/read/29439608/a-review-of-ustekinumab-in-the-treatment-of-psoriatic-arthritis
#7
Janet Roberts, Darren D O'Rielly, Proton Rahman
Psoriatic arthritis is an inflammatory arthritis associated with psoriasis. The IL-23/IL-17 axis is an important pathway in the development of psoriatic disease. Ustekinumab is a fully human monoclonal IgG1 antibody that binds to the p40 subunit of IL-12 and IL-23, which, in turn, inhibits downstream signaling pathways. PSUMMIT-1 and PSUMMIT-2 are two pivotal Phase III trials demonstrating global improvement in primary and secondary outcomes including inhibition of radiographic progression. Therapeutic benefit of ustekinumab for synovitis appears independent of previous disease modifying antirheumatic disease or anti-TNF exposure...
February 14, 2018: Immunotherapy
https://www.readbyqxmd.com/read/29438373/anlotinib-as-a-third-line-therapy-in-patients-with-refractory-advanced-non-small-cell-lung-cancer-a-multicentre-randomised-phase-ii-trial-alter0302
#8
Baohui Han, Kai Li, Yizhuo Zhao, Baolan Li, Ying Cheng, Jianying Zhou, You Lu, Yuankai Shi, Zhehai Wang, Liyan Jiang, Yi Luo, Yiping Zhang, Cheng Huang, Qiang Li, Guoming Wu
BACKGROUND: Anlotinib (AL3818) is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. The objective of this study was to assess the safety and efficacy of third-line anlotinib for patients with refractory advanced non-small-cell lung cancer (RA-NSCLC). METHODS: Eligible patients were randomised 1 : 1 to receive anlotinib (12 mg per day, per os; days 1-14; 21 days per cycle) or a placebo. The primary end point was progression-free survival (PFS)...
February 13, 2018: British Journal of Cancer
https://www.readbyqxmd.com/read/29438372/a-phase-i-trial-of-the-%C3%AE-secretase-inhibitor-mk-0752-in-combination-with-gemcitabine-in-patients-with-pancreatic-ductal-adenocarcinoma
#9
Natalie Cook, Bristi Basu, Donna-Michelle Smith, Aarthi Gopinathan, Jeffry Evans, William P Steward, Daniel Palmer, David Propper, Balaji Venugopal, Mirela Hategan, D Alan Anthoney, Lisa V Hampson, Michael Nebozhyn, David Tuveson, Hayley Farmer-Hall, Helen Turner, Robert McLeod, Sarah Halford, Duncan Jodrell
BACKGROUND: The Notch pathway is frequently activated in cancer. Pathway inhibition by γ-secretase inhibitors has been shown to be effective in pre-clinical models of pancreatic cancer, in combination with gemcitabine. METHODS: A multi-centre, non-randomised Bayesian adaptive design study of MK-0752, administered per os weekly, in combination with gemcitabine administered intravenously on days 1, 8 and 15 (28 day cycle) at 800 or 1000 mg m -2 , was performed to determine the safety of combination treatment and the recommended phase 2 dose (RP2D)...
February 13, 2018: British Journal of Cancer
https://www.readbyqxmd.com/read/29438325/untargeted-metabolomics-profiling-of-an-80-5-km-simulated-treadmill-ultramarathon
#10
Christopher C F Howe, Ahmed Alshehri, David Muggeridge, Alexander B Mullen, Marie Boyd, Owen Spendiff, Hannah J Moir, David G Watson
Metabolomic profiling of nine trained ultramarathon runners completing an 80.5 km self-paced treadmill-based time trial was carried out. Plasma samples were obtained from venous whole blood, collected at rest and on completion of the distance (post-80.5 km). The samples were analyzed by using high-resolution mass spectrometry in combination with both hydrophilic interaction (HILIC) and reversed phase (RP) chromatography. The extracted putatively identified features were modeled using Simca P 14.1 software (Umetrics, Umea, Sweden)...
February 13, 2018: Metabolites
https://www.readbyqxmd.com/read/29435872/a-phase-ii-trial-of-concurrent-chemoradiotherapy-with-weekly-paclitaxel-and-carboplatin-in-advanced-oesophageal-carcinoma
#11
Kuai-Le Zhao, Yi Xia, Yun-Hai Li, Yun Chen, Qi Liu, Jun-Hua Zhang, Jia-Ying Deng, Ta-Shan Ai, Han-Ting Zhu, Harun Badakhshi
BACKGROUND: This study was performed to assess the efficacy and feasibility of definitive chemoradiotherapy consisting of weekly doses of combined paclitaxel and carboplatin concurrent with radiation therapy, followed by 2 cycles of consolidation chemotherapy for advanced esophageal carcinoma. METHODS: Eligibility criteria included local, advanced, newly diagnosed and postoperative local regional lymph node metastasis; Eastern Cooperative Oncology Group (ECOG) score ≤ 2; and adequate organ function...
February 12, 2018: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29435849/denosumab-a-review-in-postmenopausal-osteoporosis
#12
Emma D Deeks
Denosumab (Prolia®; Pralia®) is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once every 6 months and is approved for various indications, including the treatment of postmenopausal (PM) women with osteoporosis at increased/high risk of fracture or failure/intolerance of other osteoporosis therapies (indications featured in this review). Denosumab showed benefit in several phase 3 or 4 studies in PM women with osteoporosis or low bone mineral density (BMD), including the pivotal 3-year double-blind FREEDOM trial and its 7-year open-label extension...
February 12, 2018: Drugs & Aging
https://www.readbyqxmd.com/read/29435776/effect-of-anagliptin-and-sitagliptin-on-low-density-lipoprotein-cholesterol-in-type-2-diabetic-patients-with-dyslipidemia-and-cardiovascular-risk-rationale-and-study-design-of-the-reason-trial
#13
Shinichiro Ueda, Michio Shimabukuro, Osamu Arasaki, Koichi Node, Takashi Nomiyama, Takeshi Morimoto
BACKGROUND: Reduction of low-density lipoprotein cholesterol (LDL-C) is important for patients with a high risk for atherosclerotic events, such as patients with diabetes and other risk factors. Anagliptin was reported to reduce LDL-C for 12 weeks in phase III trials regardless of the use of statins, but it is uncertain whether this effect is common to other dipeptidylpeptidase-4 (DPP-4) inhibitors. METHODS: A multicenter, randomized, open-label, parallel-group trial was conducted to confirm the superiority of anagliptin to sitagliptin in terms of the primary endpoint of reduction of LDL-C for 52 weeks in patients with type 2 diabetes and atherosclerotic vascular lesions, as well as the non-inferiority of anagliptin to sitagliptin in terms of change in hemoglobin A1c (HbA1c)...
February 12, 2018: Cardiovascular Drugs and Therapy
https://www.readbyqxmd.com/read/29434569/cranio-caudal-kinematic-turn-signature-assessed-with-inertial-systems-as-a-marker-of-mobility-deficits-in-parkinson-s-disease
#14
Karina Lebel, Christian Duval, Hung Phuc Nguyen, Réjean Plamondon, Patrick Boissy
Background: Turning is a challenging mobility task requiring proper planning, coordination, and postural stability to be executed efficiently. Turn deficits can impair mobility and lead to falls in patients with neurodegenerative disease, such as Parkinson's disease (PD). It was previously shown that the cranio-caudal sequence involved during a turn (i.e., motion is initiated by the head, followed by the trunk) exhibits a signature that can be captured using an inertial system and analyzed through the Kinematics Theory...
2018: Frontiers in Neurology
https://www.readbyqxmd.com/read/29434384/formulary-drug-review-betrixaban
#15
REVIEW
Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers...
February 2018: Hospital Pharmacy
https://www.readbyqxmd.com/read/29433963/pertuzumab-and-trastuzumab-with-or-without-metronomic-chemotherapy-for-older-patients-with-her2-positive-metastatic-breast-cancer-eortc-75111-10114-an-open-label-randomised-phase-2-trial-from-the-elderly-task-force-breast-cancer-group
#16
Hans Wildiers, Konstantinos Tryfonidis, Lissandra Dal Lago, Peter Vuylsteke, Giuseppe Curigliano, Simon Waters, Barbara Brouwers, Sevilay Altintas, Nathan Touati, Fatima Cardoso, Etienne Brain
BACKGROUND: Despite the high incidence of metastatic breast cancer and its related mortality in the elderly population, our knowledge about optimal treatment for older patients with cancer is far from adequate. We aimed to evaluate the efficacy of dual anti-HER2 treatment with or without metronomic chemotherapy in older patients with HER2-positive metastatic breast cancer. METHODS: We did a multicentre, open-label, randomised, phase 2 trial in 30 centres from eight countries in Europe, in patients with histologically proven, HER2-positive metastatic breast cancer, without previous chemotherapy for metastatic disease, who were 70 years or older, or 60 years or older with confirmed functional restrictions defined by protocol, and had a life expectancy of more than 12 weeks and a performance status according to WHO scale of 0-3...
February 9, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29433902/safety-and-efficacy-of-pd-1-pd-l1-inhibitors-in-treatment-naive-and-chemotherapy-refractory-patients-with-non-small-cell-lung-cancer-a-systematic-review-and-meta-analysis
#17
Monica Khunger, Prantesh Jain, Sagar Rakshit, Vinay Pasupuleti, Adrian V Hernandez, James Stevenson, Nathan A Pennell, Vamsidhar Velcheti
INTRODUCTION: Programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors show significant clinical activity in non-small-cell lung carcinoma (NSCLC). However, there is a relative lack of data on comparative efficacy of these drugs in the first-line setting versus chemotherapy-treated patients. We compared the efficacy and toxicity of these drugs in these 2 distinct groups of patients. MATERIALS AND METHODS: Electronic databases (PubMed-Medline, EMBASE, Scopus) and major conference proceedings were systematically searched for all phase I to III clinical trials in NSCLC using PD-1/PD-L1 inhibitors...
January 10, 2018: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29433850/lenvatinib-versus-sorafenib-in-first-line-treatment-of-patients-with-unresectable-hepatocellular-carcinoma-a-randomised-phase-3-non-inferiority-trial
#18
Masatoshi Kudo, Richard S Finn, Shukui Qin, Kwang-Hyub Han, Kenji Ikeda, Fabio Piscaglia, Ari Baron, Joong-Won Park, Guohong Han, Jacek Jassem, Jean Frederic Blanc, Arndt Vogel, Dmitry Komov, T R Jeffry Evans, Carlos Lopez, Corina Dutcus, Matthew Guo, Kenichi Saito, Silvija Kraljevic, Toshiyuki Tamai, Min Ren, Ann-Lii Cheng
BACKGROUND: In a phase 2 trial, lenvatinib, an inhibitor of VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor α, RET, and KIT, showed activity in hepatocellular carcinoma. We aimed to compare overall survival in patients treated with lenvatinib versus sorafenib as a first-line treatment for unresectable hepatocellular carcinoma. METHODS: This was an open-label, phase 3, multicentre, non-inferiority trial that recruited patients with unresectable hepatocellular carcinoma, who had not received treatment for advanced disease, at 154 sites in 20 countries throughout the Asia-Pacific, European, and North American regions...
February 9, 2018: Lancet
https://www.readbyqxmd.com/read/29433537/effect-of-mobile-health-on-maternal-health-care-service-utilization-in-eastern-ethiopia-study-protocol-for-a-randomized-controlled-trial
#19
Tilayie Feto Gelano, Nega Assefa, Yadeta Dessie Bacha, Afendi Abdi Mahamed, Kedir Teji Roba, Mitiku Teshome Hambisa
BACKGROUND: Globally, the rapid development of mobile technology has created new ways of addressing public health challenges and shifted the paradigm of health care access and delivery. The primary aim of this study is to examine the effectiveness of Mobile-health on maternal health care service utilization in Eastern Ethiopia. METHODS/DESIGN: Through, a cluster-randomized controlled trial, 640 participants will be selected based on their districts and respective health centers as the unit of randomization...
February 12, 2018: Trials
https://www.readbyqxmd.com/read/29433525/assessment-of-clinical-effect-and-treatment-quality-of-immediate-release-carvedilol-ir-versus-slow-release-carvedilol-sr-in-heart-failure-patients-slow-hf-study-protocol-for-a-randomized-controlled-trial
#20
Dong-Ju Choi, Chan Soon Park, Jin Joo Park, Hae-Young Lee, Seok-Min Kang, Byung-Su Yoo, Eun-Seok Jeon, Seok Keun Hong, Joon-Han Shin, Myung-A Kim, Dae-Gyun Park, Eung-Ju Kim, Soon-Jun Hong, Seok Yeon Kim, Jae-Joong Kim
BACKGROUND: Carvedilol is a non-selective, third-generation beta-blocker and is one of the cornerstones for treatment for patients with heart failure and reduced ejection fraction (HFrEF). However, due to its short half-life, immediate-release carvedilol (IR) needs to be prescribed twice a day. Recently, slow-release carvedilol (SR) has been developed. The aim of this study is to evaluate whether carvedilol-SR is non-inferior to standard carvedilol-IR in terms of its clinical efficacy in patients with HFrEF...
February 13, 2018: Trials
keyword
keyword
118843
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"