keyword
MENU ▼
Read by QxMD icon Read
search

Phase 1 clinical trial

keyword
https://www.readbyqxmd.com/read/28930600/line-1-as-a-therapeutic-target-for-castration-resistant-prostate-cancer
#1
Nadine Houede, Pier Vincenzo Piazza, Philippe Pourquier
Prostate cancer is the third leading cause of death by cancer in men. Surgery or hormone deprivation usually contains the progression of the local forms of the disease. In metastatic situations, chemotherapy or second generation hormone therapies are used with an overall survival that never exceeds 36 months when tumors become resistant to castration. In the search for new alternatives, clinical trials with various classes of anticancer drugs have been performed, including chemotherapies, targeted therapies with kinase inhibitors, radium-223, or immunotherapies with somehow limited efficacy...
January 1, 2018: Frontiers in Bioscience (Landmark Edition)
https://www.readbyqxmd.com/read/28930490/tezacaftor-ivacaftor-in-subjects-with-cystic-fibrosis-and-f508del-f508del-cftr-or-f508del-g551d-cftr
#2
Scott H Donaldson, Joseph M Pilewski, Matthias Griese, Jon Cooke, Lakshmi Viswanathan, Elizabeth Tullis, Jane C Davies, Julie A Lekstrom-Himes, Linda T Wang
RATIONALE: Tezacaftor (formerly VX-661) is an investigational small molecule that improves processing and trafficking of the cystic fibrosis transmembrane conductance regulator (CFTR) in vitro, and improves CFTR function alone and in combination with ivacaftor. OBJECTIVES: To evaluate safety and efficacy of tezacaftor monotherapy and tezacaftor/ivacaftor combination therapy in subjects with CF homozygous for F508del or compound heterozygous for F508del and G551D...
September 20, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28929255/carbonic-anhydrase-ix-inhibition-affects-viability-of-cancer-cells-adapted-to-extracellular-acidosis
#3
Elena Andreucci, Silvia Peppicelli, Fabrizio Carta, Giulia Brisotto, Eva Biscontin, Jessica Ruzzolini, Francesca Bianchini, Alessio Biagioni, Claudiu T Supuran, Lido Calorini
Among the players of the adaptive response of cancer cells able to promote a resistant and aggressive phenotype, carbonic anhydrase IX (CAIX) recently has emerged as one of the most relevant drug targets. Indeed, CAIX targeting has received a lot of interest, and selective inhibitors are currently under clinical trials. Hypoxia has been identified as the master inductor of CAIX, but, to date, very few is known about the influence that another important characteristic of tumor microenvironment, i.e., extracellular acidosis, exerts on CAIX expression and activity...
September 19, 2017: Journal of Molecular Medicine: Official Organ of the "Gesellschaft Deutscher Naturforscher und Ärzte"
https://www.readbyqxmd.com/read/28929209/upper-urinary-tract-effects-after-irreversible-electroporation-ire-of-human-localised-renal-cell-carcinoma-rcc-in-the-irene-pilot-phase-2a-ablate-and-resect-study
#4
J J Wendler, M Pech, J Köllermann, B Friebe, S Siedentopf, S Blaschke, D Schindele, M Porsch, D Baumunk, J Jürgens, F Fischbach, J Ricke, M Schostak, M Böhm, U B Liehr
PURPOSE: Irreversible electroporation (IRE) is a new potential ablation modality for small renal masses. Animal experiments have shown preservation of the urine-collecting system (UCS). The purpose of this clinical study was to perform the first evaluation and comparison of IRE's effects on the renal UCS by using urinary cytology, magnetic-resonance imaging, and resection histology in men after IRE of pT1a renal-cell carcinoma (RCC). METHODS: Seven patients with biopsy-proven RCC pT1a cN0cM0 underwent IRE in a phase 2a pilot ablate-and-resect study (IRENE trial)...
September 19, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28929168/long-term-impact-of-ixekizumab-on-psoriasis-itch-severity-results-from-a-phase-iii-clinical-trial-and-long-term-extension
#5
Alexandra B Kimball, Thomas Luger, Alice Gottlieb, Luis Puig, Roland Kaufmann, Russel Burge, Chen-Yen Lin, Gil Yosipovitch
Itching is a prevalent plaque psoriasis symptom. Ixekizumab, an IL-17A antagonist, has demonstrated rapid, significant improvements in itch severity over 12 weeks in Phase III psoriasis trials (UNCOVER-1, UNCOVER-2). We assessed the long-term (through 60 weeks) effect of ixekizumab maintenance therapy (80-mg ixekizumab every 4 weeks [IXEQ4W]) on itch severity, using the Itch Numeric Rating Scale, in psoriasis patients who received ixekizumab, placebo, or etanercept for 12 weeks in the Phase III UNCOVER-3 trial...
September 20, 2017: Acta Dermato-venereologica
https://www.readbyqxmd.com/read/28928910/phase-i-ii-randomized-controlled-trial-of-autologous-bone-marrow-derived-mesenchymal-stem-cell-therapy-for-chronic-stroke
#6
Kam Sze Tsang, Chi Ping Stephanie Ng, Xian Lun Zhu, George Kwok Chu Wong, Gang Lu, Anil Tejbhan Ahuja, Ka Sing Lawrence Wong, Ho Keung Ng, Wai Sang Poon
AIM: To examine the safety and efficacy of mesenchymal stem cell (MSC) therapy for intracerebral haemorrhage with neurological dysfunctions for a year. METHODS: MSC were ex vivo expanded from 29 mL (17-42 mL) autologous bone marrow. Patients were randomized to have two intravenous injections of autologous MSC or placebos in four weeks apart. Neurological functions and clinical outcomes were monitored before treatment and at 12(th), 16(th), 24(th), 36(th) and 60(th) week upon completion of the treatment...
August 26, 2017: World Journal of Stem Cells
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
#7
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
#8
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/28927103/lack-of-chemopreventive-efficacy-of-metformin-in-rodent-models-of-urinary-bladder-head-and-neck-and-colon-intestine-cancer
#9
Matthew D Thompson, Ronald A Lubet, David L Mccormick, Margie L Clapper, Ann M Bode, M Margaret Juliana, Fariba Moeinpour, Clinton J Grubbs
Metformin is a biguanide employed in treating type II diabetes. Its potential efficacy for treating cancer has been demonstrated epidemiologically (lower cancer incidence in metformin users compared with users of sulfonylureas or insulin) and mechanistically, primarily in cell culture. Metformin decreases the levels of insulin-like growth factor 1 and secondarily inhibits the mammalian target of rapamycin pathway to exhibit anticancer effects. The current study examined its cancer preventive efficacy in multiple standard in situ arising cancer models...
September 2017: Oncology Letters
https://www.readbyqxmd.com/read/28926956/carbonic-anhydrase-inhibition-and-the-management-of-hypoxic-tumors
#10
REVIEW
Claudiu T Supuran
Hypoxia and acidosis are salient features of many tumors, leading to a completely different metabolism compared to normal cells. Two of the simplest metabolic products, protons and bicarbonate, are generated by the catalytic activity of the metalloenzyme carbonic anhydrase (CA, EC 4.2.1.1), with at least two of its isoforms, CA IX and XII, mainly present in hypoxic tumors. Inhibition of tumor-associated CAs leads to an impaired growth of the primary tumors, metastases and reduces the population of cancer stem cells, leading thus to a complex and beneficial anticancer action for this class of enzyme inhibitors...
September 16, 2017: Metabolites
https://www.readbyqxmd.com/read/28926579/cervical-screening-with-primary-hpv-testing-or-cytology-in-a-population-of-women-in-which-those-aged-33-years-or-younger-had-previously-been-offered-hpv-vaccination-results-of-the-compass-pilot-randomised-trial
#11
Karen Canfell, Michael Caruana, Val Gebski, Jessica Darlington-Brown, Stella Heley, Julia Brotherton, Dorota Gertig, Chloe J Jennett, Annabelle Farnsworth, Jeffrey Tan, C David Wrede, Philip E Castle, Marion Saville
BACKGROUND: Using primary human papillomavirus (HPV) testing for cervical screening increases detection of high-grade cervical intraepithelial neoplastic lesions and invasive cancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) compared to cytology, but no evaluation has been conducted in a population previously offered HPV vaccination. We aimed to assess colposcopy referral and CIN2+ detection rates for HPV-screened versus cytology-screened women in Australia's HPV-vaccinated population (by 2014, resident women ≤33 years had been age-eligible for HPV vaccination, with 3-dose uptake across age cohorts being about 50%-77%)...
September 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28926529/first-line-folfiri-and-bevacizumab-in-patients-with-advanced-colorectal-cancer-prospectively-stratified-according-to-serum-ldh-final-results-of-the-giscad-italian-group-for-the-study-of-digestive-tract-cancers-central-colorectalavastintrialldh-trial
#12
Riccardo Giampieri, Marco Puzzoni, Bruno Daniele, Daris Ferrari, Sara Lonardi, Alberto Zaniboni, Luigi Cavanna, Gerardo Rosati, Nicoletta Pella, Maria Giulia Zampino, Pietro Sozzi, Domenico Germano, Vittorina Zagonel, Carla Codecà, Michela Libertini, Roberto Labianca, Stefano Cascinu, Mario Scartozzi
BACKGROUND: Previous findings suggested that bevacizumab might be able to improve response rate (RR) in colorectal cancer patients with high lactic dehydrogenase (LDH) basal levels. METHODS: We conducted a phase II trial to prospectively ascertain whether bevacizumab in combination with FOLFIRI could have an improved clinical activity in patients with high LDH serum levels. Primary end point of the study was RR; secondary end points were median overall survival and median progression-free survival (mPFS)...
September 19, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28926423/a-noninterventional-multicenter-prospective-phase-iv-study-of-trabectedin-in-patients-with-advanced-soft-tissue-sarcoma
#13
Angela Buonadonna, Charlotte Benson, Jose Casanova, Bernd Kasper, Antonio López Pousa, Filomena Mazzeo, Thomas Brodowicz, Nicolas Penel
This prospective, noninterventional study is the first phase IV trial designed to evaluate trabectedin in patients with advanced soft tissue sarcoma in real-life clinical practice across Europe. To be included in the study, patients must have received more than or equal to one cycle of trabectedin and be currently on treatment. The primary endpoint was progression-free survival as defined by investigators. The secondary endpoints included objective response rate, disease control rate, time to progression and the growth modulation index (GMI), overall survival, and an assessment of the cancer-related symptoms and safety...
September 18, 2017: Anti-cancer Drugs
https://www.readbyqxmd.com/read/28926357/first-in-human-treatment-with-a-dendritic-cell-targeting-lentiviral-vector-expressing-ny-eso-1-lv305-induces-deep-durable-response-in-refractory-metastatic-synovial-sarcoma-patient
#14
Seth M Pollack, Hailing Lu, Sacha Gnjatic, Neeta Somaiah, Ryan B O'Malley, Robin L Jones, Frank J Hsu, Jan Ter Meulen
Effective induction of antitumor T cells is a pivotal goal of cancer immunotherapy. To this end, lentiviral vectors (LV) are uniquely poised to directly prime CD8 T-cell responses via transduction of dendritic cells in vivo and have shown promise as active cancer therapeutics in preclinical tumor models. However, until now, significant barriers related to production and regulation have prevented their widespread use in the clinic. We developed LV305, a dendritic cell-targeting, integration-deficient, replication incompetent LV from the ZVex platform, encoding the full-length cancer-testis antigen NY-ESO-1...
September 18, 2017: Journal of Immunotherapy
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
#15
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/28926120/glecaprevir-pibrentasvir-for-hcv-genotype-3-patients-with-cirrhosis-and-or-prior-treatment-experience-a-partially-randomized-phase-iii-clinical-trial
#16
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/28924870/efficacy-of-a-novel-sigma-1-receptor-antagonist-for-oxaliplatin-induced-neuropathy-a-randomized-double-blind-placebo-controlled-phase-iia-clinical-trial
#17
Jordi Bruna, Sebastián Videla, Andreas A Argyriou, Roser Velasco, Jesús Villoria, Cristina Santos, Cristina Nadal, Guido Cavaletti, Paola Alberti, Chiara Briani, Haralabos P Kalofonos, Diego Cortinovis, Mariano Sust, Anna Vaqué, Thomas Klein, Carlos Plata-Salamán
This trial assessed the efficacy of MR309 (a novel selective sigma-1 receptor ligand previously developed as E-52862) in ameliorating oxaliplatin-induced peripheral neuropathy (oxaipn). A discontinuous regimen of MR309 (400 mg/day, 5 days per cycle) was tested in patients with colorectal cancer receiving FOLFOX in a phase II, randomized, double-blind, placebo-controlled, multicenter clinical trial. Outcome measures included changes in 24-week quantitative measures of thermal sensitivity and total neuropathy score...
September 18, 2017: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
https://www.readbyqxmd.com/read/28924549/potassium-2-1-hydroxypentyl-benzoate-attenuates-neuronal-apoptosis-in-neuron-astrocyte-co-culture-system-through-neurotrophy-and-neuroinflammation-pathway
#18
Dongmei Liu, Man Zhang, Xianfang Rong, Jiang Li, Xiaoliang Wang
Potassium 2-(1-hydroxypentyl)-benzoate (d,l-PHPB), a new drug candidate for ischemic stroke at the phase II clinic trial, has been shown to protect neurons by inhibiting oxidative injury and reducing neuron apoptosis in previous studies. But the mechanisms of d,l-PHPB remain to be studied. In this study, a neuron-astrocytes co-culture system was used to elucidate the roles of astrocytes in neuroprotection of d,l-PHPB under oxygen-glucose deprivation/reoxygenation (OGD/R) condition. Our data showed that d,l-PHPB reduced neuronal apoptosis in mono-culture system and this effect was enhanced in neuron-astrocyte co-culture system under the OGD/R condition...
September 2017: Acta Pharmaceutica Sinica. B
https://www.readbyqxmd.com/read/28923793/dose-comparison-study-of-allogeneic-mesenchymal-stem-cells-in-patients-with-ischemic-cardiomyopathy-the-trident-study
#19
Victoria Florea, Angela C Rieger, Darcy L Difede, Jill El-Khorazaty, Makoto Natsumeda, Monisha N Banerjee, Bryon A Tompkins, Aisha Khan, Ivonne H Schulman, Ana M Landin, Muzammil Mushtaq, Maureen H Lowery, John Byrnes, Robert C Hendel, Mauricio G Cohen, Krystalenia Valasaki, Marietsy V Pujol, Eduard Ghersin, Roberto Miki, Cindy Delgado, Fouad A Abuzeid, Mayra Vidro-Casiano, Russell Saltzman, Daniel DaFonseca, Lina V Caceres, Kevin N Ramdas, Adam Mendizabal, Alan W Heldman, Raul D Mitrani, Joshua M Hare
Rationale: Cell dose and concentration play crucial roles in phenotypic responses to cell-based therapy for heart failure. Objective: To compare the safety and efficacy of two doses of allogeneic bone marrow-derived human mesenchymal stem cells (hMSC) identically delivered in patients with ischemic cardiomyopathy (ICM). Methods and Results: Thirty patients with ICM received in a blinded manner either 20 million (20M, n=15) or 100 million (100M, n=15) allogeneic hMSCs via transendocardial injection (10 0.5 cc injections/patient)...
September 18, 2017: Circulation Research
https://www.readbyqxmd.com/read/28923789/assessing-the-efficacy-and-safety-of-an-11%C3%AE-hydroxysteroid-dehydrogenase-type-1-inhibitor-azd4017-in-the-idiopathic-intracranial-hypertension-drug-trial-iih-dt-clinical-methods-and-design-for-a-phase-ii-randomized-controlled-trial
#20
Keira Annie Markey, Ryan Ottridge, James L Mitchell, Caroline Rick, Rebecca Woolley, Natalie Ives, Peter Nightingale, Alexandra J Sinclair
BACKGROUND: Idiopathic intracranial hypertension (IIH) is a condition with few effective management options. So far, there have been no randomized controlled trials evaluating new treatments in IIH. OBJECTIVES: The purpose of this paper is to outline the trial design for the Idiopathic Intracranial Hypertension Drug Trial (IIH:DT), assessing an innovative medical treatment in IIH and the rationale for the chosen trial methodology. METHODS: IIH:DT is a phase II double-blind randomized placebo-controlled trial recruiting 30 female participants with active IIH (intracranial pressure >25cm H2 O and papilledema)...
September 18, 2017: JMIR Research Protocols
keyword
keyword
48709
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"