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clinical trial phase III

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https://www.readbyqxmd.com/read/29147135/randomized-clinical-trial-efficacy-and-safety-of-plecanatide-in-the-treatment-of-chronic-idiopathic-constipation
#1
Michael DeMicco, Laura Barrow, Bernadette Hickey, Kunwar Shailubhai, Patrick Griffin
Background: Plecanatide, with the exception of a single amino acid replacement, is identical to human uroguanylin and is approved in the United States for adults with chronic idiopathic constipation (CIC). This double-blind, placebo-controlled, phase III study evaluated the efficacy and safety of plecanatide versus placebo in CIC. Methods: Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445)...
November 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/29146441/combining-immunotherapies-for-the-treatment-of-prostate-cancer
#2
REVIEW
Jason M Redman, James L Gulley, Ravi A Madan
Sipuleucel-T, a therapeutic dendritic-cell vaccine, was Food and Drug Administration-approved for prostate cancer in 2010. No new immunotherapies for prostate cancer have been approved since. However, novel agents and combination approaches offer great promise for improving outcomes for prostate cancer patients. Here we review the latest developments in immunotherapy for prostate cancer. Sipuleucel-T has demonstrated a survival advantage of 4.1 months in metastatic castration-resistant prostate cancer. PSA-TRICOM (PROSTVAC), a prostate-specific antigen-targeted vaccine platform, showed evidence of clinical and immunologic efficacy in early-phase clinical trials, and results from a phase III trial in advanced disease are pending...
December 2017: Urologic Oncology
https://www.readbyqxmd.com/read/29145561/clinical-significance-of-cd73-in-triple-negative-breast-cancer-multiplex-analysis-of-a-phase-iii-clinical-trial
#3
L Buisseret, S Pommey, B Allard, S Garaud, M Bergeron, I Cousineau, L Ameye, Y Bareche, M Paesmans, J P A Crown, A Di Leo, S Loi, M Piccart-Gebhart, K Willard-Gallo, C Sotiriou, J Stagg
Background: CD73 is an ecto-enzyme that promotes tumor immune escape through the production of immunosuppressive extracellular adenosine in the tumor microenvironment. Several CD73 inhibitors and adenosine receptor antagonists are being evaluated in phase I clinical trials. Patients and methods: Full-face sections from formalin-fixed paraffin-embedded primary breast tumors from 122 samples of triple-negative breast cancer from the BIG 02-98 adjuvant phase III clinical trial were included in our analysis...
November 14, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29145211/patient-reported-outcome-results-from-the-open-label-randomized-phase-iii-select-bc-trial-evaluating-first-line-s-1-therapy-for-metastatic-breast-cancer
#4
Takuya Kawahara, Kojiro Shimozuma, Takeru Shiroiwa, Yasuhiro Hagiwara, Yukari Uemura, Takanori Watanabe, Naruto Taira, Takashi Fukuda, Yasuo Ohashi, Hirofumi Mukai
OBJECTIVE: To evaluate the effects of S-1, an orally administered 5-FU agent, versus taxane on patient-reported outcomes (PROs) in the SELECT BC trial. METHODS: Patients with HER2-negative and endocrine treatment-resistant breast cancer with metastasis or recurrence after surgery were randomly assigned to receive first-line taxane or S-1. PROs (secondary endpoint) were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Patient Neurotoxicity Questionnaire (PNQ) at baseline and at 3, 6, and 12 months...
November 17, 2017: Oncology
https://www.readbyqxmd.com/read/29142965/ferritin-elevation-and-improved-responsiveness-to-erythropoiesis-stimulating-agents-in%C3%A2-patients-on-ferric-citrate-hydrate
#5
Keitaro Yokoyama, Masafumi Fukagawa, Takashi Akiba, Masaaki Nakayama, Toshiya Otoguro, Kana Yamada, Yasuo Nagamine, Steven Fishbane, Hideki Hirakata
Introduction: In hemodialysis patients on ferric citrate hydrate, the increase in ferritin level is mainly due to the administration of the compound. We investigated possible other factors associated with ferritin level and how erythropoietin resistance index and erythropoiesis in those patients were affected. We looked at ferritin-elevating factors using data from a Japanese phase III long-term clinical trial of ferric citrate hydrate. Methods: The factors with a strong association with ferritin levels at week 28 were selected by the process of variable selection...
May 2017: KI Reports
https://www.readbyqxmd.com/read/29142012/a-transcatheter-interatrial-shunt-device-for-the-treatment-of-heart-failure-with-preserved-ejection-fraction-reduce-lap-hf-i-a-phase-2-randomized-sham-controlled-trial
#6
Ted Feldman, Laura Mauri, Rami Kahwash, Sheldon Litwin, Mark J Ricciardi, Pim van der Harst, Martin Penicka, Peter S Fail, David M Kaye, Mark C Petrie, Anupam Basuray, Scott L Hummel, Rhondalyn Forde-McLean, Christopher D Nielsen, Scott Lilly, Joseph M Massaro, Daniel Burkhoff, Sanjiv J Shah
Background -In non-randomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), less symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and mid-range or preserved ejection fraction (EF ≥ 40%). We conducted the first randomized, sham-controlled trial to evaluate the IASD in HF with EF ≥ 40%. Methods -REDUCE LAP-HF I was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association (NYHA) class III or ambulatory class IV HF, EF ≥ 40%, exercise PCWP ≥ 25 mmHg, and PCWP-right atrial pressure gradient ≥ 5 mmHg...
November 15, 2017: Circulation
https://www.readbyqxmd.com/read/29140831/relative-efficacies-of-hboc-201-and-polyheme-to-increase-oxygen-transport-compared-to-blood-and-crystalloids-2017-military-supplement
#7
Gregory P Dubé, Arkadiy N Pitman, Colin F Mackenzie
BACKGROUND: Because total hemoglobin in circulation ([THb]) is an established predictor of clinical outcomes in anemic individuals, the relative efficacies of resuscitation fluids to increase [THb] can be used to design better hemoglobin-based oxygen carrier (HBOC) clinical trials. METHODS: Expected efficacies of HBOC-201 (13 g Hb/dL) and packed RBCs (pRBCs, 24 g Hb/dL) to increase [THb] were calculated and interpreted in the context of SAEs in the HEM-0115 phase III clinical trial...
November 14, 2017: Shock
https://www.readbyqxmd.com/read/29138583/efficacy-of-intravenous-tigecycline-in-patients-with-acinetobacter-complex-infections-results-from-14-phase-iii-and-phase-iv-clinical-trials
#8
Hal Tucker, Michele Wible, Ashesh Gandhi, Alvaro Quintana
Background: Acinetobacter infections, especially multidrug-resistant (MDR) Acinetobacter infections, are a global health problem. This study aimed to describe clinical outcomes in patients with confirmed Acinetobacter spp. isolates who were treated with tigecycline in randomized clinical trials. Materials and methods: Data from 14 multinational, randomized (open-label or double-blind), and active-controlled (except one) Phase III and IV studies were analyzed using descriptive statistics...
2017: Infection and Drug Resistance
https://www.readbyqxmd.com/read/29138536/spotlight-on-siponimod-and-its-potential-in-the-treatment-of-secondary-progressive-multiple-sclerosis-the-evidence-to-date
#9
REVIEW
Alberto Gajofatto
Siponimod (BAF312) is a synthetic molecule belonging to the sphingosine-1-phosphate (S1P) modulator family, which has putative neuroprotective properties and well-characterized immunomodulating effects mediated by sequestration of B and T cells in secondary lymphoid organs. Compared to fingolimod (ie, precursor of the S1P modulators commercially available for the treatment of relapsing-remitting [RR] multiple sclerosis [MS]), siponimod exhibits selective affinity for types 1 and 5 S1P receptor, leading to a lower risk of adverse events that are mainly induced by S1P3 receptor activation, such as bradycardia and vasoconstriction...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29138320/structural-basis-for-antibody-recognition-of-the-nanp-repeats-in-plasmodium-falciparum-circumsporozoite-protein
#10
David Oyen, Jonathan L Torres, Ulrike Wille-Reece, Christian F Ockenhouse, Daniel Emerling, Jacob Glanville, Wayne Volkmuth, Yevel Flores-Garcia, Fidel Zavala, Andrew B Ward, C Richter King, Ian A Wilson
Acquired resistance against antimalarial drugs has further increased the need for an effective malaria vaccine. The current leading candidate, RTS,S, is a recombinant circumsporozoite protein (CSP)-based vaccine against Plasmodium falciparum that contains 19 NANP repeats followed by a thrombospondin repeat domain. Although RTS,S has undergone extensive clinical testing and has progressed through phase III clinical trials, continued efforts are underway to enhance its efficacy and duration of protection. Here, we determined that two monoclonal antibodies (mAbs 311 and 317), isolated from a recent controlled human malaria infection trial exploring a delayed fractional dose, inhibit parasite development in vivo by at least 97%...
November 14, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/29136453/randomized-phase-iii-trial-of-adjuvant-therapy-with-locoregional-interferon-beta-versus-surgery-alone-in-stage-ii-iii-cutaneous-melanoma-japan-clinical-oncology-group-study-jcog1309-j-feron
#11
Kenjiro Namikawa, Arata Tsutsumida, Tomonori Mizutani, Taro Shibata, Tatsuya Takenouchi, Shusuke Yoshikawa, Yoshio Kiyohara, Hiroshi Uchi, Masutaka Furue, Dai Ogata, Tetsuya Tsuchida, Naoya Yamazaki
The Dermatologic Oncology Group of Japan Clinical Oncology Group has started a randomized phase III trial to confirm the superiority of adjuvant therapy with locoregional interferon beta in overall survival over surgery alone for patients with pathological stage II/III cutaneous melanoma (JCOG1309). Patients in the interferon beta arm receive intra- or subcutaneous injections of interferon beta directly into the surgical site at a flat dose of 3 million units once per day. Treatment is repeated for 10 consecutive days every 8 weeks for a total of 3 courses during the induction phase, then 1-day injection every 4 weeks for 2...
July 1, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29136387/randomized-multicenter-placebo-controlled-clinical-trial-of-duloxetine-versus-placebo-for-aromatase-inhibitor-associated-arthralgias-in-early-stage-breast-cancer-swog-s1202
#12
N Lynn Henry, Joseph M Unger, Anne F Schott, Louis Fehrenbacher, Patrick J Flynn, Debra M Prow, Carl W Sharer, Gary V Burton, Charles S Kuzma, Anna Moseley, Danika L Lew, Michael J Fisch, Carol M Moinpour, Dawn L Hershman, James L Wade
Purpose Adherence to aromatase inhibitor (AI) therapy for early-stage breast cancer is limited by AI-associated musculoskeletal symptoms (AIMSS). Duloxetine is US Food and Drug Administration approved for treatment of multiple chronic pain disorders. We hypothesized that treatment of AIMSS with duloxetine would improve average joint pain compared with placebo. Methods This randomized, double-blind, phase III trial included AI-treated postmenopausal women with early-stage breast cancer and who had average joint pain score of ≥ 4 out of 10 that developed or worsened since AI therapy initiation...
November 14, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29136187/a-phase-iii-trial-of-a-single-early-intravesical-instillation-of-pirarubicin-to-prevent-bladder-recurrence-after-radical-nephroureterectomy-for-upper-tract-urothelial-carcinoma-jcog1403-utuc-thp-phase-iii
#13
Kenichi Miyamoto, Akihiro Ito, Masashi Wakabayashi, Junko Eba, Yoichi Arai, Hiroyuki Nishiyama, Mikio Sugimoto, Ryo Yamashita, Yoshiyuki Kakehi
Observation is the current standard for managing cases of Stage 0a-III upper tract urothelial carcinoma after radical nephroureterectomy. A randomized Phase III trial commenced in Japan during October 2016. The trial is designed to investigate the superiority of a single early intravesical instillation of pirarubicin, compared with observation, in terms of relapse-free survival after radical nephroureterectomy for Stage 0a-III upper tract urothelial carcinoma. During a 5-year period, 310 patients will be recruited from 43 Japanese institutions...
November 9, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29134824/an-overview-of-the-role-of-carfilzomib-in-the-treatment-of-multiple-myeloma
#14
Dimitrios C Ziogas, Evangelos Terpos, Efstathios Kastritis, Meletios A Dimopoulos
Carfilzomib is a second-generation proteasome inhibitor that binds selectively and irreversibly with the chymotrypsin-like site of the proteolytic core. Its initial approval by the Food and Drug Administration, as monotherapy for relapsed/refractory multiple myeloma (RR-MM), followed soon by a global authorization of its combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of RR-MM after 1-3 prior lines. In order to optimize its administration, carfilzomib is currently examined in different doses and regimens in relapsed/refractory as well as in newly diagnosed myeloma...
November 14, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29134822/treating-moderate-to-severe-plaque-psoriasis-with-guselkumab-a-review-of-phase-ii-and-phase-iii-trials
#15
Seth T Howell, Leah A Cardwell, Steven R Feldman
OBJECTIVE: Guselkumab, an anti-interleukin-23 monoclonal antibody was recently approved for the treatment of patients with moderate-to-severe plaque psoriasis. This article will review the available phase II and phase III guselkumab clinical trial data. DATA SOURCES: A PubMed search was conducted using the terms guselkumab, interleukin-23, psoriasis, adalimumab, and ustekinumab (January 2014 to August 2017). STUDY SELECTION AND DATA EXTRACTION: Articles detailing the results of phase II and phase III clinical trials were selected for review...
November 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29134566/lisdexamfetamine-a-review-in-binge-eating-disorder
#16
Young-A Heo, Sean T Duggan
Oral lisdexamfetamine dimesylate (Vyvanse(®); lisdexamfetamine), a prodrug of dextroamfetamine, is currently the only drug to be approved in the USA for the treatment of moderate to severe binge eating disorder (BED) in adult patients. Its approval was based on the results of two pivotal short-term (12 weeks) phase III studies, which showed a significantly greater reduction in binge eating days/week at the end of the study with lisdexamfetamine 50-70 mg/day than with placebo. The findings of these studies have been supported and extended by the results of longer-term (≤ 52 weeks) phase III studies, including one with a randomized 26-week withdrawal phase, which showed that lisdexamfetamine markedly reduced the risk of BED relapse relative to placebo...
November 13, 2017: CNS Drugs
https://www.readbyqxmd.com/read/29132404/comparison-of-the-efficacy-and-safety-of-fp-1201-lyo-intravenously-administered-recombinant-human-interferon-beta-1a-and-placebo-in-the-treatment-of-patients-with-moderate-or-severe-acute-respiratory-distress-syndrome-study-protocol-for-a-randomized-controlled
#17
Geoff Bellingan, David Brealey, Jordi Mancebo, Alain Mercat, Nicolò Patroniti, Ville Pettilä, Michael Quintel, Jean-Louis Vincent, Mikael Maksimow, Markku Jalkanen, Ilse Piippo, V Marco Ranieri
BACKGROUND: Acute respiratory distress syndrome (ARDS) results in vascular leakage, inflammation and respiratory failure. There are currently no approved pharmacological treatments for ARDS and standard of care involves treatment of the underlying cause, and supportive care. The vascular leakage may be related to reduced concentrations of local adenosine, which is involved in maintaining endothelial barrier function. Interferon (IFN) beta-1a up-regulates the cell surface ecto-5'-nucleotidase cluster of differentiation 73 (CD73), which increases adenosine levels, and IFN beta-1 may, therefore, be a potential treatment for ARDS...
November 13, 2017: Trials
https://www.readbyqxmd.com/read/29130344/neurokinin-1-receptor-antagonists-in-the-prevention-of-chemotherapy-induced-nausea-and-vomiting-focus-on-fosaprepitant
#18
Bernardo L Rapoport, Karin Jordan, Cindy Weinstein
Chemotherapy-induced nausea and vomiting (CINV) remains a challenge in cancer care. Improved understanding of CINV pathophysiology has triggered the development of new antiemetic therapeutic options, such as selective neurokinin-1 (NK1) receptor antagonists (RAs), which effectively prevent CINV when added to a standard antiemetic regimen (serotonin-3 RA and dexamethasone). Aprepitant and its water-soluble prodrug, fosaprepitant dimeglumine, are the most widely used NK1 RAs, with extensive clinical use worldwide...
November 13, 2017: Future Oncology
https://www.readbyqxmd.com/read/29128193/vitamin-d-levels-vitamin-d-receptor-polymorphisms-and-inflammatory-cytokines-in-aromatase-inhibitor-induced-arthralgias-an-analysis-of-cctg-ma-27
#19
Polly Niravath, Bingshu Chen, Judy-Anne W Chapman, Sandeep K Agarwal, Robert L Welschhans, Tim Bongartz, Krishna R Kalari, Lois E Shepherd, John Bartlett, Kathleen Pritchard, Karen Gelmon, Susan G Hilsenbeck, Mothaffar F Rimawi, C Kent Osborne, Paul E Goss, James N Ingle
BACKGROUND: Approximately half of women taking aromatase inhibitor (AI) therapy develop AI-induced arthralgia (AIA), and many might discontinue AI therapy because of the pain. Using plasma samples from the MA.27 study, we assessed several factors potentially associated with AIA. PATIENTS AND METHODS: MA.27 is a phase III adjuvant trial comparing 2 AIs, exemestane versus anastrozole. Within an 893-participant nested case-control AIA genome-wide association study, we nested a 72 AIA case-144 control assessment of vitamin D plasma concentrations, corrected for seasonal and geographic variation...
October 16, 2017: Clinical Breast Cancer
https://www.readbyqxmd.com/read/29126091/older-cancer-patients-in-cancer-clinical-trials-are-underrepresented-systematic-literature-review-of-almost-5000-meta-and-pooled-analyses-of-phase-iii-randomized-trials-of-survival-from-breast-prostate-and-lung-cancer
#20
REVIEW
Cita Dunn, Andrew Wilson, Freddy Sitas
BACKGROUND: Older people represent increasing proportions of the population with cancer. To understand the representivity of cancer treatments in older people, we performed a systematic literature review using PRISMA guidelines of the age distribution of clinical trial participants for three leading cancer types, namely breast, prostate, and lung. METHODS: We used PubMed to identify articles detailing meta or pooled-analyses of phase III, randomised controlled trials (RCTs) of survival for breast, prostate and lung cancer, published ≤5 years from 2016...
November 7, 2017: Cancer Epidemiology
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