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Phase I trials

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https://www.readbyqxmd.com/read/28651338/evaluation-of-the-impact-of-tumor-hpv-status-on-outcome-in-patients-with-locally-advanced-unresectable-head-and-neck-squamous-cell-carcinoma-hnscc-receiving-cisplatin-5-fluorouracil-with-or-without-docetaxel-a-subset-analysis-of-eortc-24971-study
#1
A Psyrri, C Fortpied, G Koutsodontis, M Avgeris, C Kroupis, N Goutas, J Menis, L Herman, L Giurgea, E Remenar, M Degardin, I S Pateras, J A Langendijk, C van Herpen, A Awada, J R Germà-Lluch, H R Kienzer, L Licitra, J B Vermorken
Background: EORTC 24971 was a phase III trial demonstrating superiority of induction regimen TPF over PF, in terms of progression-free (PFS) and overall survival (OS) in locoregionally advanced unresectable HNSCC. We conducted a retrospective analysis of prospectively collected data aiming to evaluate whether only HPV(-) patients (pts) benefit from adding docetaxel to PF, in which case de-intensifying induction treatment in HPV(+) pts could be considered. Methods: Pre-therapy tumor biopsies (blocks or slides) were assessed for high-risk HPV by p16 immunohistochemistry, PCR and qPCR...
June 23, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28651023/many-to-one-comparisons-after-safety-selection-in-multi-arm-clinical-trials
#2
Gerald Hlavin, Lisa V Hampson, Franz Koenig
In phase II platform trials, 'many-to-one' comparisons are performed when K experimental treatments are compared with a common control to identify the most promising treatment(s) to be selected for Phase III trials. However, when sample sizes are limited, such as when the disease of interest is rare, only a single Phase II/III trial addressing both treatment selection and confirmatory efficacy testing may be feasible. In this paper, we suggest a two-step safety selection and testing procedure for such seamless trials...
2017: PloS One
https://www.readbyqxmd.com/read/28650455/clinical-impact-of-nk-cell-reconstitution-after-reduced-intensity-conditioned-unrelated-cord-blood-transplantation-in-patients-with-acute-myeloid-leukemia-analysis-of-a-prospective-phase-ii-multicenter-trial-on-behalf-of-the-soci%C3%A3-t%C3%A3-fran%C3%A3-aise-de-greffe-de
#3
S Nguyen, A Achour, L Souchet, S Vigouroux, P Chevallier, S Furst, A Sirvent, J-O Bay, G Socié, P Ceballos, A Huynh, J Cornillon, S Francois, F Legrand, I Yakoub-Agha, G Michel, N Maillard, G Margueritte, S Maury, M Uzunov, C-E Bulabois, M Michallet, L Clement, C Dauriac, K Bilger, J Lejeune, V Béziat, V Rocha, B Rio, S Chevret, V Vieillard
Unrelated cord blood transplantation (UCBT) after a reduced intensity conditioning regimen (RIC) has extended the use of UCB in elderly patients and those with co-morbidities without an HLA-identical donor, although post-transplant relapse remains a concern in high-risk acute myeloid leukemia (AML) patients. HLA incompatibilities between donor and recipient might enhance the alloreactivity of natural killer (NK) cells after allogeneic hematopoietic stem-cell transplantation (HSCT). We studied the reconstitution of NK cells and KIR-L mismatch in 54 patients who underwent a RIC-UCBT for AML in CR in a prospective phase II clinical trial...
June 26, 2017: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/28647166/clinical-development-of-a-recombinant-ebola-vaccine-in-the-midst-of-an-unprecedented-epidemic
#4
Beth-Ann G Coller, Jeffrey Blue, Rituparna Das, Sheri Dubey, Lynn Finelli, Swati Gupta, Frans Helmond, Rebecca J Grant-Klein, Kenneth Liu, Jakub Simon, Sean Troth, Susan VanRheenen, Julie Waterbury, Ashley Wivel, Jayanthi Wolf, D Gray Heppner, Tracy Kemp, Rick Nichols, Thomas P Monath
The 2014-2016 Ebola outbreak caused over 28,000 cases and 11,000 deaths. Merck & Co. Inc., Kenilworth, NJ USA and NewLink Genetics are working with private and public partners to develop and license an Ebola vaccine that was evaluated extensively during the outbreak. The vaccine referred to as V920 is a recombinant vesicular stomatitis virus (rVSV) in which the VSV-G envelope glycoprotein (GP) is completely replaced by the Zaire ebolavirus GP (rVSVΔG-ZEBOV-GP). Eight Phase I and four Phase II/III clinical trials enrolling approximately 17,000 subjects were conducted in parallel to the outbreak to assess the safety, immunogenicity, and/or efficacy of V920...
June 21, 2017: Vaccine
https://www.readbyqxmd.com/read/28646851/development-of-an-education-campaign-to-reduce-delays-in-pre-hospital-response-to-stroke
#5
Caterina Caminiti, Peter Schulz, Barbara Marcomini, Elisa Iezzi, Silvia Riva, Umberto Scoditti, Andrea Zini, Giovanni Malferrari, Maria Luisa Zedde, Donata Guidetti, Enrico Montanari, Mario Baratti, Licia Denti
BACKGROUND: Systematic reviews call for well-designed trials with clearly described intervention components to support the effectiveness of educational campaigns to reduce patient delay in stroke presentation. We herein describe the systematic development process of a campaign aimed to increase stroke awareness and preparedness. METHODS: Campaign development followed Intervention Mapping (IM), a theory- and evidence-based tool, and was articulated in two phases: needs assessment and intervention development...
June 24, 2017: BMC Emergency Medicine
https://www.readbyqxmd.com/read/28645985/a-study-protocol-for-a-randomised-controlled-trial-of-an-interactive-web-based-intervention-cancercope
#6
Suzanne K Chambers, Lee Ritterband, Frances Thorndike, Lisa Nielsen, Joanne F Aitken, Samantha Clutton, Paul Scuffham, Philippa Youl, Bronwyn Morris, Peter Baade, Jeffrey Dunn
INTRODUCTION: Approximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer. METHODS AND ANALYSIS: In phase I, the intervention was developed on an interactive web platform and pilot tested for acceptability using a qualitative methodology with 21 patients with cancer...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645915/cebranopadol-blocks-the-escalation-of-cocaine-intake-and-conditioned-reinstatement-of-cocaine-seeking-in-rats
#7
Giordano de Guglielmo, Alessandra Matzeu, Jenni Kononoff, Julia Mattioni, Remi Martin-Fardon, Olivier George
Cebranopadol is a novel agonist of nociceptin/orphanin FQ peptide (NOP) and opioid receptors with analgesic properties that is being evaluated in clinical Phase 2 and Phase 3 trials for the treatment of chronic and acute pain. Recent evidence indicates that the combination of opioid and NOP receptor agonism may be a new treatment strategy for cocaine addiction. We sought to extend these findings by examining the effects of cebranopadol on cocaine self-administration (0.5 mg/kg/infusion) and cocaine conditioned reinstatement in rats with extended access to cocaine...
June 23, 2017: Journal of Pharmacology and Experimental Therapeutics
https://www.readbyqxmd.com/read/28645776/selective-inhibition-of-flt3-by-gilteritinib-in-relapsed-or-refractory-acute-myeloid-leukaemia-a-multicentre-first-in-human-open-label-phase-1-2-study
#8
Alexander E Perl, Jessica K Altman, Jorge Cortes, Catherine Smith, Mark Litzow, Maria R Baer, David Claxton, Harry P Erba, Stan Gill, Stuart Goldberg, Joseph G Jurcic, Richard A Larson, Chaofeng Liu, Ellen Ritchie, Gary Schiller, Alexander I Spira, Stephen A Strickland, Raoul Tibes, Celalettin Ustun, Eunice S Wang, Robert Stuart, Christoph Röllig, Andreas Neubauer, Giovanni Martinelli, Erkut Bahceci, Mark Levis
BACKGROUND: Internal tandem duplication mutations in FLT3 are common in acute myeloid leukaemia and are associated with rapid relapse and short overall survival. The clinical benefit of FLT3 inhibitors in patients with acute myeloid leukaemia has been limited by rapid generation of resistance mutations, particularly in codon Asp835 (D835). We aimed to assess the highly selective oral FLT3 inhibitor gilteritinib in patients with relapsed or refractory acute myeloid leukaemia. METHODS: In this phase 1-2 trial, we enrolled patients aged 18 years or older with acute myeloid leukaemia who either were refractory to induction therapy or had relapsed after achieving remission with previous treatment...
June 20, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28645636/theobromine-does-not-affect-postprandial-lipid-metabolism-and-duodenal-gene-expression-but-has-unfavorable-effects-on-postprandial-glucose-and-insulin-responses-in-humans
#9
Lotte Smolders, Ronald P Mensink, Mark V Boekschoten, Rogier J J de Ridder, Jogchum Plat
BACKGROUND & AIMS: Chocolate consumption is associated with a decreased risk for CVD. Theobromine, a compound in cocoa, may explain these effects as it favorably affected fasting serum lipids. However, long-term effects of theobromine on postprandial metabolism as well as underlying mechanisms have never been studied. The objective was to evaluate the effects of 4-week theobromine consumption (500 mg/day) on fasting and postprandial lipid, lipoprotein and glucose metabolism, and duodenal gene expression...
June 10, 2017: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/28643244/durvalumab-first-global-approval
#10
Yahiya Y Syed
Intravenous durvalumab (Imfinzi™; AstraZeneca) is a fully human monoclonal antibody that blocks programmed cell death ligand-1 binding to its receptors (PD-1 and CD80), resulting in enhanced T-cell responses against cancer cells. The US FDA has granted durvalumab accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy...
June 22, 2017: Drugs
https://www.readbyqxmd.com/read/28643057/single-incision-laparoscopic-common-bile-duct-exploration-in-101-consecutive-patients-choledochotomy-transcystic-and-transfistulous-approaches
#11
Shu-Hung Chuang, Min-Chang Hung, Shih-Wei Huang, Dev-Aur Chou, Hurng-Sheng Wu
BACKGROUND: Laparoscopic surgery for choledocholithiasis is still evolving. Only a few reports of single-incision laparoscopic common bile duct exploration (LCBDE) have been published. METHODS: One hundred and one consecutive patients underwent single-incision LCBDE (SILCBDE) by one surgeon with straight instruments during a 42-month period. RESULTS: Choledochotomies were performed on 61 patients (60.4%). The success rate of intrahepatic duct exploration was 68...
June 22, 2017: Surgical Endoscopy
https://www.readbyqxmd.com/read/28642820/intratumorally-injected-pro-inflammatory-allogeneic-dendritic-cells-as-immune-enhancers-a-first-in-human-study-in-unfavourable-risk-patients-with-metastatic-renal-cell-carcinoma
#12
Anna Laurell, Maria Lönnemark, Einar Brekkan, Anders Magnusson, Anna Tolf, Anna Carin Wallgren, Bengt Andersson, Lars Adamson, Rolf Kiessling, Alex Karlsson-Parra
BACKGROUND: Accumulating pre-clinical data indicate that the efficient induction of antigen-specific cytotoxic CD8+ T cells characterizing viral infections is caused by cross-priming where initially infected DCs produce an unique set of inflammatory factors that recruit and activate non-infected bystander DCs. Our DC-based immunotherapy concept is guided by such bystander view and accordingly, we have developed a cellular adjuvant consisting of pre-activated allogeneic DCs producing high levels of DC-recruiting and DC-activating factors...
2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28641357/-the-german-thorax-registry-implementation-of-an-established-tool-of-perioperative-health-care-research
#13
Jérôme Defosse, Mark Schieren, Torsten Loop, Cerstin Arndt, Rainer Röhrig, Erich Stoelben, Corinna Ludwig, Alexander Schleppers, Frank Wappler, Mark Gerbershagen, Alberto Lopez-Pastorini
The collection of clinical treatment data in registry databases is an important aspect of health services research. It allows for a critical evaluation of the safety, efficacy and cost-effectiveness of clinical treatment concepts in large patient populations. The findings of registry research represent real-world patients and treatment structures as they are not limited by strict inclusion criteria or unrealistic conditions as applied in prospective clinical trials. The implementation of the German Thorax Registry has enabled the collection and analysis of data on the interdisciplinary care (thoracic surgery, anaesthesiology, intensive care, pain management) of patients undergoing thoracic surgery...
June 2017: Zentralblatt Für Chirurgie
https://www.readbyqxmd.com/read/28637922/targeting-factor-d-of-the-alternative-complement-pathway-reduces-geographic-atrophy-progression-secondary-to-age-related-macular-degeneration
#14
Brian L Yaspan, David F Williams, Frank G Holz, Carl D Regillo, Zhengrong Li, Amy Dressen, Menno van Lookeren Campagne, Kha N Le, Robert R Graham, Tatiana Beres, Tushar R Bhangale, Lee A Honigberg, Ashley Smith, Erin C Henry, Carole Ho, Erich C Strauss
Geographic atrophy is an advanced form of age-related macular degeneration (AMD) and a leading cause of vision loss for which there are no approved treatments. Genetic studies in AMD patients have implicated dysregulation of the alternative complement pathway in the pathogenesis of geographic atrophy. Lampalizumab is a potential therapeutic that targets complement factor D, a pivotal activator of the alternative complement pathway. The MAHALO phase 2 clinical trial was a multicenter, randomized, controlled study that evaluated lampalizumab administered by intravitreal injection monthly (n = 42) and every other month (n = 41) versus sham control (n = 40) in patients with geographic atrophy secondary to AMD...
June 21, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28636883/the-effects-of-monocular-training-on-binocular-functions-in-anisometropic-amblyopia
#15
Wuli Jia, Fangfang Lan, Zhao Xin, Zhong-Lin Lu, Chang-Bing Huang, Wuxiao Zhao, Min Li
PURPOSE: It's been shown that intensive monocular perceptual learning can improve visual acuity, contrast sensitivity, and vernier acuity in the amblyopic eye in adults with amblyopia. It is however not clear how much monocular training can enhance binocular visual functions. In the current study, we aimed to evaluate effects of monocular training on a variety of binocular functions. METHODS: Nineteen anisometropic amblyopes (18.5±1.26 yrs) were trained in a grating contrast detection task near each individual's cutoff spatial frequency for 6 to 10 days (630 trials/day)...
June 18, 2017: Vision Research
https://www.readbyqxmd.com/read/28636538/phase-i-dose-escalation-study-of-the-c-met-tyrosine-kinase-inhibitor-sar125844-in-asian-patients-with-advanced-solid-tumors-including-patients-with-met-amplified-gastric-cancer
#16
Kohei Shitara, Tae Min Kim, Tomoya Yokota, Masahiro Goto, Taroh Satoh, Jin-Hee Ahn, Hyo Song Kim, Sylvie Assadourian, Corinne Gomez, Marzia Harnois, Satoshi Hamauchi, Toshihiro Kudo, Toshihido Doi, Yung-Jue Bang
SAR125844 is a potent and selective inhibitor of the c-Met kinase receptor. This was an open-label, phase I, multicenter, dose-escalation, and dose-expansion trial of SAR125844 in Asian patients with solid tumors, a subgroup of whom had gastric cancer and MET amplification (NCT01657214). SAR125844 was administered by intravenous infusion (260-570 mg/m2) on days 1, 8, 15, and 22 of each 28-day cycle. Objectives were to determine the maximum tolerated dose (MTD) and to evaluate SAR125844 safety and pharmacokinetic profile...
June 16, 2017: Oncotarget
https://www.readbyqxmd.com/read/28636208/a-phase-i-trial-of-prn1008-a-novel-reversible-covalent-inhibitor-of-bruton-s-tyrosine-kinase-in-healthy-volunteers
#17
Patrick F Smith, Janakan Krishnarajah, Philip A Nunn, Ron J Hill, Dane Karr, D Tam, Mohammad Masjedizadeh, Jens O Funk, Steve G Gourlay
AIM: To evaluate the safety, tolerability, and PK/PD of PRN1008, a novel BTK inhibitor, in healthy volunteers, and thus determine the dose range for future clinical studies. METHODS: This was a two-part randomized, placebo controlled study in healthy volunteers using a liquid formulation. Part I was a single ascending dose design with dose levels of 50 to 1200 mg (n=6 active, 2 placebo per cohort); Part II was a multiple ascending dose design, with dose regimens ranging from 300 mg to 900 mg daily, either qd or bd for 10 days...
June 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28634446/are-distal-and-proximal-visual-cues-equally-important-during-spatial-learning-in-mice-a-pilot-study-of-overshadowing-in-the-spatial-domain
#18
Marie Hébert, Jan Bulla, Denis Vivien, Véronique Agin
Animals use distal and proximal visual cues to accurately navigate in their environment, with the possibility of the occurrence of associative mechanisms such as cue competition as previously reported in honey-bees, rats, birds and humans. In this pilot study, we investigated one of the most common forms of cue competition, namely the overshadowing effect, between visual landmarks during spatial learning in mice. To this end, C57BL/6J × Sv129 mice were given a two-trial place recognition task in a T-maze, based on a novelty free-choice exploration paradigm previously developed to study spatial memory in rodents...
2017: Frontiers in Behavioral Neuroscience
https://www.readbyqxmd.com/read/28634245/targeting-nectin-4-in-bladder-cancer
#19
(no author information available yet)
Preliminary findings from a phase I clinical trial indicate that enfortumab vedotin, an investigational antibody-drug conjugate targeting nectin-4, shows considerable efficacy in metastatic urothelial carcinoma. Robust responses were seen even among patients with disease progression on platinum chemotherapy and/or immune checkpoint blockade.
June 20, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28633425/androgen-receptor-mutations-in-patients-with-castration-resistant-prostate-cancer-treated-with-apalutamide
#20
D E Rathkopf, M R Smith, C J Ryan, W R Berry, N D Shore, G Liu, C S Higano, J J Alumkal, R Hauke, R F Tutrone, M Saleh, E Chow Maneval, S Thomas, D S Ricci, M K Yu, C J de Boer, A Trinh, T Kheoh, R Bandekar, H I Scher, E S Antonarakis
Background: : Mutations in the androgen receptor (AR) ligand-binding domain (LBD), such as F877L and T878A, have been associated with resistance to next-generation AR-directed therapies. ARN-509-001 was a phase I/II study that evaluated apalutamide activity in castration-resistant prostate cancer (CRPC). Here we evaluated the type and frequency of 11 relevant AR-LBD mutations in apalutamide-treated CRPC patients. Patients and methods: : Blood samples from men with non-metastatic CRPC (nmCRPC) and metastatic CRPC (mCRPC) pre- or post abiraterone acetate and prednisone (AAP) treatment (≥6 months' exposure) were evaluated at baseline and disease progression in trial ARN-509-001...
June 15, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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