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https://www.readbyqxmd.com/read/27932411/mod-4023-a-long-acting-carboxy-terminal-peptide-ctp-modified-human-growth-hormone-results-of-a-phase-2-study-in-growth-hormone-deficient-adults
#1
Christian J Strasburger, Peter Vanuga, Juraj Payer, Marija Pfeifer, Vera Popović, Laszlo Bajnok, Miklós I Góth, Věra Olšovská, Ľudmila Trejbalová, Janos Vadasz, Eyal Fima, Ronit Koren, Leanne Amitzi, Martin Bidlingmaier, Gili Hart, Beverly M K Biller
OBJECTIVE: Growth hormone (GH) replacement therapy currently requires daily injections, which may cause distress and low compliance. C-terminal peptide (CTP)-modified growth hormone (MOD-4023) is being developed as a once-weekly dosing regimen in patients with GH deficiency (GHD). This study's objective is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MOD-4023 administered once weekly in GHD adults. DESIGN: 54 adults with GHD currently treated with daily GH were normalized and randomized into 4 weekly dosing cohorts of MOD-4023 at 18...
December 8, 2016: European Journal of Endocrinology
https://www.readbyqxmd.com/read/27932229/regorafenib-for-patients-with-hepatocellular-carcinoma-who-progressed-on-sorafenib-treatment-resorce-a-randomised-double-blind-placebo-controlled-phase-3-trial
#2
Jordi Bruix, Shukui Qin, Philippe Merle, Alessandro Granito, Yi-Hsiang Huang, György Bodoky, Marc Pracht, Osamu Yokosuka, Olivier Rosmorduc, Valeriy Breder, René Gerolami, Gianluca Masi, Paul J Ross, Tianqiang Song, Jean-Pierre Bronowicki, Isabelle Ollivier-Hourmand, Masatoshi Kudo, Ann-Lii Cheng, Josep M Llovet, Richard S Finn, Marie-Aude LeBerre, Annette Baumhauer, Gerold Meinhardt, Guohong Han
BACKGROUND: There are no systemic treatments for patients with hepatocellular carcinoma (HCC) whose disease progresses during sorafenib treatment. We aimed to assess the efficacy and safety of regorafenib in patients with HCC who have progressed during sorafenib treatment. METHODS: In this randomised, double-blind, parallel-group, phase 3 trial done at 152 sites in 21 countries, adults with HCC who tolerated sorafenib (≥400 mg/day for ≥20 of last 28 days of treatment), progressed on sorafenib, and had Child-Pugh A liver function were enrolled...
December 5, 2016: Lancet
https://www.readbyqxmd.com/read/27932067/nivolumab-plus-ipilimumab-as-first-line-treatment-for-advanced-non-small-cell-lung-cancer-checkmate-012-results-of-an-open-label-phase-1-multicohort-study
#3
Matthew D Hellmann, Naiyer A Rizvi, Jonathan W Goldman, Scott N Gettinger, Hossein Borghaei, Julie R Brahmer, Neal E Ready, David E Gerber, Laura Q Chow, Rosalyn A Juergens, Frances A Shepherd, Scott A Laurie, William J Geese, Shruti Agrawal, Tina C Young, Xuemei Li, Scott J Antonia
BACKGROUND: Nivolumab has shown improved survival in the treatment of advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy. We assessed the safety and activity of combination nivolumab plus ipilimumab as first-line therapy for NSCLC. METHODS: The open-label, phase 1, multicohort study (CheckMate 012) cohorts reported here were enrolled at eight US academic centres. Eligible patients were aged 18 years or older with histologically or cytologically confirmed recurrent stage IIIb or stage IV, chemotherapy-naive NSCLC...
December 2, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27931834/treatments-for-colorectal-liver-metastases-a-new-focus-on-a-familiar-concept
#4
REVIEW
M G Zampino, E Magni, P S Ravenda, C A Cella, G Bonomo, P Della Vigna, S Galdy, F Spada, G M Varano, G Mauri, N Fazio, F Orsi
A major challenge for the management of advanced-colorectal-cancer is the multidisciplinary approach required for the treatment of liver metastases. Reducing the burden of liver metastases with liver-directed therapy has an important impact on both survival and health-related quality of life. This paper debates the rationale and current liver-directed approaches for colorectal liver metastases based on the evidence of literature and new clinical trials. Surgery is the gold standard, when feasible, and it's the main treatment goal for patients with potentially-resectable disease as a means of prolonging progression-free survival...
December 2016: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/27930924/effect-of-radium-223-dichloride-ra-223-on-hospitalisation-an-analysis-from-the-phase-3-randomised-alpharadin-in-symptomatic-prostate-cancer-patients-alsympca-trial
#5
Christopher Parker, Lin Zhan, Paul Cislo, Jonathan Reuning-Scherer, Nicholas J Vogelzang, Sten Nilsson, Oliver Sartor, Joe M O'Sullivan, Robert E Coleman
Symptomatic skeletal events (SSEs) commonly occur in patients with bone metastases, often leading to hospitalisations and decreased quality-of-life. In the ALSYMPCA trial, radium-223 significantly improved overall survival (hazard ratio 0.70, 95% confidence interval [CI] 0.58-0.83, P < 0.001) and prolonged time to first SSE (hazard ratio 0.66, 95% CI 0.52-0.83, P = 0.00037) and subsequent SSE (hazard ratio 0.65, 95% CI 0.51-0.83, P = 0.00039) versus placebo in patients with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases...
December 5, 2016: European Journal of Cancer
https://www.readbyqxmd.com/read/27930762/effect-of-standard-radiotherapy-with-cisplatin-vs-accelerated-radiotherapy-with-panitumumab-in-locoregionally-advanced-squamous-cell-head-and-neck-carcinoma-a-randomized-clinical-trial
#6
Lillian L Siu, John N Waldron, Bingshu E Chen, Eric Winquist, Jim R Wright, Abdenour Nabid, John H Hay, Jolie Ringash, Geoffrey Liu, Ana Johnson, George Shenouda, Martin Chasen, Andrew Pearce, James B Butler, Stephen Breen, Eric Xueyu Chen, T J FitzGerald, T J Childs, Alexander Montenegro, Brian O'Sullivan, Wendy R Parulekar
Importance: The Canadian Cancer Trials Group study HN.6 is the largest randomized clinical trial to date comparing the concurrent administration of anti-epidermal growth factor receptor (EGFR) monoclonal antibodies with radiotherapy (RT) to standard chemoradiotherapy in locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Objective: To compare progression-free survival (PFS) in patients with LA-SCCHN treated with standard-fractionation RT plus high-dose cisplatin vs accelerated-fractionation RT plus the anti-EGFR antibody panitumumab...
December 8, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27930642/adjuvant-treatment-for-renal-cell-carcinoma-do-we-finally-have-a-major-breakthrough
#7
Devin N Patel, Robert A Figlin, Hyung L Kim
Clinical parameters can be used to identify patients at greatest risk for recurrence following nephrectomy for clinically localized renal cell carcinoma (RCC). Molecular tools are being developed to improve risk stratification. An increasing list of available treatments for metastatic RCC continues to provide hope that an effective adjuvant therapy will be identified for patients with high-risk, clinically localized disease. In a phase 3 adjuvant therapy trial (S-TRAC), sunitinib increased median disease-free survival in patients with clear cell RCC who were at very high risk...
November 2016: Clinical Advances in Hematology & Oncology: H&O
https://www.readbyqxmd.com/read/27930630/obesity-and-breast-cancer-risk-outcomes-and-future-considerations
#8
Rachel L Yung, Jennifer A Ligibel
The proportion of adults who are obese has increased dramatically in the United States over the last 30 years. Obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. Evidence also suggests that obesity at the time of breast cancer diagnosis is linked to an increased risk of breast cancer-specific and overall mortality in both premenopausal and postmenopausal women with early-stage breast cancer. Obesity is linked to an increased risk of secondary malignancies in women with early breast cancer, and studies suggest that weight gain after diagnosis increases overall mortality...
October 2016: Clinical Advances in Hematology & Oncology: H&O
https://www.readbyqxmd.com/read/27929203/real-time-dose-adjustment-using-point-of-care-platelet-reactivity-testing-in-a-double-blind-study-of-prasugrel-in-children-with-sickle-cell-anaemia
#9
Joseph A Jakubowski, Carolyn C Hoppe, Chunmei Zhou, Brendan E Smith, Patricia B Brown, Lori E Heath, Baba Inusa, David C Rees, David S Small, Neehar Gupta, Suqin Yao, Matthew Heeney, Julie Kanter
Patients with sickle cell anaemia (SCA) have vaso-occlusive crises resulting from occlusive hypoxic-ischaemic injury. Prasugrel inhibits platelet activation and aggregation involved in SCA pathophysiology. Determining Effects of Platelet Inhibition on Vaso-Occlusive Events (DOVE) was a phase 3, double-blind, randomised, placebo-controlled trial assessing prasugrel efficacy. DOVE sought to bring patients' P2Y12 reaction unit (PRU) value within a targeted range via prasugrel dose adjustments using encrypted VerifyNow P2Y12(®) (VN-P2Y12) point-of-care testing and an interactive voice-response system (IVRS)...
December 8, 2016: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/27928191/defibrotide
#10
Danial E Baker, Kendra Demaris
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 are available online to subscribers...
November 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27927586/rituximab-bendamustine-and-low-dose-cytarabine-as-induction-therapy-in-elderly-patients-with-mantle-cell-lymphoma-a-multicentre-phase-2-trial-from-fondazione-italiana-linfomi
#11
Carlo Visco, Annalisa Chiappella, Luca Nassi, Caterina Patti, Simone Ferrero, Daniela Barbero, Andrea Evangelista, Michele Spina, Annalia Molinari, Luigi Rigacci, Monica Tani, Alice Di Rocco, Graziella Pinotti, Alberto Fabbri, Renato Zambello, Silvia Finotto, Manuel Gotti, Angelo M Carella, Flavia Salvi, Stefano A Pileri, Marco Ladetto, Giovannino Ciccone, Gianluca Gaidano, Marco Ruggeri, Maurizio Martelli, Umberto Vitolo
BACKGROUND: The combination of rituximab, bendamustine, and cytarabine (R-BAC) was highly active in a pilot trial of mantle cell lymphoma, but its use was restricted by high haematological toxicity. We aimed to assess the efficacy and safety of an R-BAC regimen with low-dose cytarabine (RBAC500). METHODS: In this multicentre, phase 2 trial, we recruited previously untreated patients with an established histological diagnosis of mantle cell lymphoma from 29 Fondazione Italiana Linfomi centres in Italy...
December 2, 2016: Lancet Haematology
https://www.readbyqxmd.com/read/27926729/intracellular-allosteric-antagonism-of-the-ccr9-receptor
#12
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
#13
(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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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