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Phase III trials

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https://www.readbyqxmd.com/read/29164421/ribociclib-plus-letrozole-versus-letrozole-alone-in-patients-with-de-novo-hr-her2-advanced-breast-cancer-in-the-randomized-monaleesa-2-trial
#1
Joyce O'Shaughnessy, Katarina Petrakova, Gabe S Sonke, Pierfranco Conte, Carlos L Arteaga, David A Cameron, Lowell L Hart, Cristian Villanueva, Erik Jakobsen, Joseph T Beck, Deborah Lindquist, Farida Souami, Shoubhik Mondal, Caroline Germa, Gabriel N Hortobagyi
PURPOSE: Determine the efficacy and safety of first-line ribociclib plus letrozole in patients with de novo advanced breast cancer. METHODS: Postmenopausal women with HR+ , HER2- advanced breast cancer and no prior systemic therapy for advanced disease were enrolled in the Phase III MONALEESA-2 trial (NCT01958021). Patients were randomized to ribociclib (600 mg/day; 3 weeks-on/1 week-off) plus letrozole (2.5 mg/day; continuous) or placebo plus letrozole until disease progression, unacceptable toxicity, death, or treatment discontinuation...
November 21, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29163985/response-to-inhaled-loxapine-in-patients-with-schizophrenia-or-bipolar-i-disorder-panss-ec-responder-analyses
#2
Scott Zeller, Leslie Zun, James V Cassella, Daniel A Spyker, Paul P Yeung
Background: Efficacy of inhaled loxapine 5 or 10 mg in treating agitation was shown using the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) in two Phase III randomised, double-blind, placebo-controlled trials in 344 agitated patients with schizophrenia and 314 patients with bipolar I disorder (Clinicaltrials.gov: NCT00628589, NCT00721955). Aims: To examine the five individual items comprising the PANSS-EC and the percentage of patients achieving a clinical response (reduction of ≥40%) in PANSS-EC (Response-40) for these two studies...
November 2017: BJPsych Open
https://www.readbyqxmd.com/read/29163981/a-comparison-of-isometric-isotonic-concentric-and-isotonic-eccentric-exercises-in-the-physiotherapy-management-of-subacromial-pain-syndrome-rotator-cuff-tendinopathy-study-protocol-for-a-pilot-randomised-controlled-trial
#3
Rita Kinsella, Sallie M Cowan, Lyn Watson, Tania Pizzari
Background: Subacromial pain syndrome (SPS) involving rotator cuff tendinopathy is a common cause of shoulder pain and disability. Evidence suggests that structured physiotherapy may be as effective as surgery in this condition with significant improvements demonstrated in trials involving scapular retraining, rotator cuff strengthening and flexibility exercises. Most published programs typically utilise isotonic concentric and/or eccentric strengthening modes. Recently, immediate analgesic effects and muscle strength gains following heavy-load isometric exercises in lower limb tendinopathy conditions have been observed...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/29162142/-heatpac-a-phase-ii-randomized-study-of-concurrent-thermochemoradiotherapy-versus-chemoradiotherapy-alone-in-locally-advanced-pancreatic-cancer
#4
Niloy Ranjan Datta, Bernhard Pestalozzi, Pierre-Alain Clavien, Alexander Siebenhüner, Emsad Puric, Shaka Khan, Christoph Mamot, Oliver Riesterer, Jürg Knuchel, Cäcilia Sophie Reiner, Stephan Bodis
BACKGROUND: Pancreatic cancer has a dismal prognosis with 5-year overall survival rate of around 5%. Although surgery is still the best option in operable cases, majority of the patients who present in locally advanced stages are deemed inoperable. Novel approaches are therefore needed for the management of around 80% of these inoperable locally advanced pancreatic cancers (LAPC). Hyperthermia (39-43 °C) is a potent radiosensitizer and further enhances the action of gemcitabine, also a known radiosensitizer...
November 21, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/29162134/serum-thymidine-kinase-1-activity-as-a-pharmacodynamic-marker-of-cyclin-dependent-kinase-4-6-inhibition-in-patients-with-early-stage-breast-cancer-receiving-neoadjuvant-palbociclib
#5
Nusayba Bagegni, Shana Thomas, Ning Liu, Jingqin Luo, Jeremy Hoog, Donald W Northfelt, Matthew P Goetz, Andres Forero, Mattias Bergqvist, Jakob Karen, Magnus Neumüller, Edward M Suh, Zhanfang Guo, Kiran Vij, Souzan Sanati, Matthew Ellis, Cynthia X Ma
BACKGROUND: Thymidine kinase 1 (TK1) is a cell cycle-regulated enzyme with peak expression in the S phase during DNA synthesis, and it is an attractive biomarker of cell proliferation. Serum TK1 activity has demonstrated prognostic value in patients with early-stage breast cancer. Because cyclin-dependent kinase 4/6 (CDK4/6) inhibitors prevent G1/S transition, we hypothesized that serum TK1 could be a biomarker for CDK4/6 inhibitors. We examined the drug-induced change in serum TK1 as well as its correlation with change in tumor Ki-67 levels in patients enrolled in the NeoPalAna trial (ClinicalTrials...
November 21, 2017: Breast Cancer Research: BCR
https://www.readbyqxmd.com/read/29161241/determination-of-an-optimal-response-cut-off-able-to-predict-progression-free-survival-in-patients-with-well-differentiated-advanced-pancreatic-neuroendocrine-tumours-treated-with-sunitinib-an-alternative-to-the-current-recist-defined-response
#6
Angela Lamarca, Jorge Barriuso, Matthew Kulke, Ivan Borbath, Heinz-Josef Lenz, Jean Luc Raoul, Neal J Meropol, Catherine Lombard-Bohas, James Posey, Sandrine Faivre, Eric Raymond, Juan W Valle
BACKGROUND: Sunitinib prolongs progression-free survival (PFS) in patients with advanced pancreatic neuroendocrine tumours (pNET). Response Evaluation Criteria in Solid Tumors (RECIST)-defined partial responses (PR; classically defined as ⩾30% size decrease from baseline) are infrequent. METHODS: Individual data of pNET patients from the phase II [NCT00056693] and pivotal phase III [NCT00428597] trials of sunitinib were analysed in this investigator-initiated, post hoc study...
November 21, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/29160173/gene-delivery-to-joints-by-intra-articular-injection
#7
Christopher H Evans, Steven Craig Ghivizzani, Paul D Robbins
Most forms of arthritis are incurable, difficult to treat and a major cause of disability in western countries. Better local treatment of arthritis is impaired by the pharmacokinetics of the joint that make it very difficult to deliver drugs to joints at sustained, therapeutic concentrations. This is especially true of biologic drugs, such as proteins and RNA, many of which show great promise in pre-clinical studies. Gene transfer provides a strategy for overcoming this limitation. The basic concept is to deliver cDNAs encoding therapeutic products by direct intra-articular injection, leading to sustained, endogenous synthesis of the gene products within the joint...
November 21, 2017: Human Gene Therapy
https://www.readbyqxmd.com/read/29158782/a-phase-ii-trial-of-preoperative-concurrent-chemotherapy-and-dose-escalated-intensity-modulated-radiotherapy-imrt-for-locally-advanced-rectal-cancer
#8
Jeremy Tey, Cheng Nang Leong, Wai Kit Cheong, Tay Guan Sze, Wei Peng Yong, Ivan Weng Keong Tham, Khai Mun Lee
Objectives: To determine the pathological response rates and toxicity and in patients with locally advanced rectal cancer treated with concurrent capecitabine and dose escalated intensity modulated radiotherapy (IMRT) Methods: Patients with stage II or III adenocarcinoma of the rectum were treated with preoperative concurrent capecitabine and IMRT. Dose of capecitabine was 825mg/m(2), 5 days a week for 5 weeks. IMRT was used to deliver a dose of 45Gy in 25 fractions (1.8Gy per fraction daily, 5 days a week over 5 weeks) to the regional lymphatics and areas at risk of harbouring microscopic disease...
2017: Journal of Cancer
https://www.readbyqxmd.com/read/29158367/safety-pharmacokinetics-pharmacodynamics-and-antitumor-activity-of-necuparanib-combined-with-nab-paclitaxel-and-gemcitabine-in-patients-with-metastatic-pancreatic-cancer-phase-i-results
#9
Eileen M O'Reilly, James Roach, Paul Miller, Kenneth H Yu, Catherine Tjan, Molly Rosano, Silva Krause, William Avery, Julie Wolf, Keith Flaherty, Darrell Nix, David P Ryan
LESSONS LEARNED: Despite the compelling preclinical rationale of evaluating the genetically engineered heparin derivative, necuparanib, combined with standard therapy in metastatic pancreas adenocarcinoma, the results were ultimately disappointing.Safety was documented, although dose escalation was limited by the number of subcutaneous injections, the potential for skin toxicity (cellulitis), and low-level anticoagulant effect. Nonetheless, the hypothesis of targeting prothrombotic pathways in pancreas adenocarcinoma remains compelling...
November 20, 2017: Oncologist
https://www.readbyqxmd.com/read/29158122/biomarkers-distinguish-hbeag-seroconverted-from-non-converted-individuals-in-chronic-hepatitis-b-patients-treated-with-a-therapeutic-vaccine
#10
Xian Zhou, Shuang Geng, Shijie Zhang, Weidong Zhao, Gan Zhao, Yumei Wen, Xuanyi Wang, Bin Wang
Cytokine assays of host immune responses to vaccination can indicate vaccine efficacy. Here we tested the hypothesis that assays of the cytokine status of infected individuals prior to therapeutic vaccination might provide a guide to vaccine therapeutic efficacy. If so, cytokine analysis might be used to select appropriate patients for therapeutic vaccination. Data were obtained from a panel of 14 cytokine/chemokine assays that were done during a phase III clinical trial of HBsAg-HBIG therapeutic vaccine (YIC) treatment of chronic hepatitis B (CHB) patients...
November 17, 2017: Cytokine
https://www.readbyqxmd.com/read/29157311/peripheral-and-local-predictive-immune-signatures-identified-in-a-phase-ii-trial-of-ipilimumab-with-carboplatin-paclitaxel-in-unresectable-stage-iii-or-stage-iv-melanoma
#11
Rahima Jamal, Réjean Lapointe, Eftihia Cocolakis, Paméla Thébault, Shirin Kazemi, Jennifer E Friedmann, Jeanne Dionne, Jean-François Cailhier, Karl Bélanger, Jean-Pierre Ayoub, Huy Le, Caroline Lambert, Jida El-Hajjar, Léon C van Kempen, Alan Spatz, Wilson H Miller
BACKGROUND: Checkpoint blockade with ipilimumab provides long-term survival to a significant proportion of patients with metastatic melanoma. New approaches to increase survival and to predict which patients will benefit from treatment are needed. This phase II trial combined ipilimumab with carboplatin/paclitaxel (CP) to assess its safety, efficacy, and to search for peripheral and tumor-based predictive biomarkers. METHODS: Thirty patients with untreated unresectable/metastatic melanoma were treated with ipilimumab and CP...
November 21, 2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29157296/biomarkers-for-immunotherapy-in-bladder-cancer-a-moving-target
#12
REVIEW
David H Aggen, Charles G Drake
Treatment options for metastatic urothelial carcinoma (mUC) remained relative unchanged over the last 30 years with combination chemotherapy as the mainstay of treatment. Within the last year the landscape for mUC has seismically shifted following the approval of five therapies targeting the programmed cell death protein (PD-1)/programmed cell death ligand 1 (PD-L1) axis. Notably, the anti-PD-1 antibody pembrolizumab demonstrated improved OS relative to chemotherapy in a randomized phase III study for second line treatment of mUC; this level 1 evidence led to approval from the U...
November 21, 2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29157275/the-prevent-study-to-evaluate-the-effectiveness-and-acceptability-of-a-community-based-intervention-to-prevent-childhood-tuberculosis-in-lesotho-study-protocol-for-a-cluster-randomized-controlled-trial
#13
Yael Hirsch-Moverman, Andrea A Howard, Koen Frederix, Limakatso Lebelo, Anneke Hesseling, Sharon Nachman, Joanne E Mantell, Tsepang Lekhela, Llang Bridget Maama, Wafaa M El-Sadr
BACKGROUND: Effective, evidence-based interventions to prevent childhood tuberculosis (TB) in high TB/HIV-burden, resource-limited settings are urgently needed. There is limited implementation of evidence-based contact management strategies, including isoniazid preventive therapy (IPT), for child contacts of TB cases in Lesotho. METHODS/DESIGN: This mixed-methods implementation science study utilizes a two-arm cluster-randomized trial design with randomization at the health facility level...
November 21, 2017: Trials
https://www.readbyqxmd.com/read/29157104/using-previous-trial-results-to-inform-hypothesis-testing-of-new-interventions
#14
Changyu Shen, Xiaochun Li
Results of industry-sponsored Phase III trials registered at clinicaltrials.gov include a rich amount of information on the efficacy of medical interventions. We propose that these results can be used to inform hypothesis testing of a new intervention through the Bayes principle. The posterior probability of positive efficacy offers an accessible interpretation of the uncertainty of efficacy and a convenient metric for global false-positive control.
November 20, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/29157068/quadrivalent-inactivated-influenza-vaccine-vaxigriptetra%C3%A2
#15
Viviane Gresset-Bourgeois, Phillip S Leventhal, Stéphanie Pepin, Rosalind Hollingsworth, Marie-Pierre Kazek-Duret, Iris De Bruijn, Sandrine I Samson
VaxigripTetra™ (IIV4; Sanofi Pasteur) is a quadrivalent split-virion influenza vaccine approved in Europe in 2016 for individuals ≥ 3 years of age. IIV4 builds on the well-established record of the trivalent split-virion influenza vaccine (Vaxigrip®). Areas covered: This literature review summarizes the rationale for developing quadrivalent influenza vaccines and discusses the phase III clinical trial results supporting the immunogenicity, safety, and tolerability of IIV4. Expert Commentary: IIV4 is immunogenic and well tolerated...
November 20, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/29156916/a-critical-evaluation-of-quality-of-life-in-clinical-trials-of-breast-cancer-patients-treated-with-radiation-therapy
#16
Gustavo N Marta, Fabio Y Moraes, Elton T T Leite, Edward Chow, David Cella, Andrew Bottomley
The aim of this study was to investigate the extent to which health-related quality of life (HRQOL) parameters have been reported in phase III trials with breast cancer patients (BCPs) who received radiation therapy (RT). We also examine the frequency and correlates of significant HRQOL gains. A systematic review was conducted. When HRQOL was a study endpoint, we extracted data on the instruments used for HRQOL analysis, assessing if there was formal statistical comparison between study groups and the results of such comparisons as reported by the authors of the studies...
October 24, 2017: Annals of Palliative Medicine
https://www.readbyqxmd.com/read/29156870/a-fully-liquid-dtap-ipv-hb-prp-t-hexavalent-vaccine-for-primary-and-booster-vaccination-of-healthy-turkish-infants-and-toddlers
#17
Mehmet Ceyhan, İnci Yıldırım, Hasan Tezer, İlker Devrim, Emmanuel Feroldi
Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-PRP-T booster at 15?18 months were evaluated. Materials and methods: This was a Phase III, randomized, open-label trial. Primary series (no hepatitis B [HB] at birth) of DTaP-IPV-HB-PRP-T (N = 155) (group 1) or licensed control vaccines (DTaP-IPV//PRP-T and standalone HB: N = 155) (group 2) and DTaP-IPV-HB-PRP-T booster were administered...
August 23, 2017: Turkish Journal of Medical Sciences
https://www.readbyqxmd.com/read/29155518/a-meta-analysis-of-clinical-trials-over-regimens-with-or-without-cetuximab-for-advanced-gastric-cancer-patients
#18
Lianhua Ji, Dongying Gu, Xinguang Tan, Hui Sun, Jinfei Chen
PURPOSE: To evaluate the efficiency and toxicity of treatment with or without cetuximab in patients with advanced gastric cancer (AGC). METHODS: Randomized phase III clinical trials (RCTs) on chemotherapy with or without cetuximab for AGC were searched in PUBMED and CNKI. A total of 874 patients were analyzed for their overall survival (OS), disease control rate (DCR), and toxicity. Reported hazard ratio (HR) with 95% CI from each study were used as the primary outcome measure...
July 2017: Journal of B.U.ON.: Official Journal of the Balkan Union of Oncology
https://www.readbyqxmd.com/read/29154721/validating-the-use-of-brain-volume-cutoffs-to-identify-clinically-relevant-atrophy-in-rrms
#19
Francesca Bovis, Nicola De Stefano, Joshua R Steinerman, Volker Knappertz, Maria Pia Sormani
BACKGROUND: Baseline brain volume (BV) is predictive at a group level but is difficult to interpret at the single patient level. OBJECTIVE: To validate BV cutoffs able to identify clinically relevant atrophy in relapsing-remitting multiple sclerosis (RRMS) patients. METHODS: The expected normalized brain volume (NBV) for each patient was calculated using RRMS patients from two phase III clinical trials, applying a linear formula developed on the baseline variable of an independent data set...
November 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/29154277/potential-of-low-dose-leuco-methylthioninium-bis-hydromethanesulphonate-lmtm-monotherapy-for-treatment-of-mild-alzheimer-s-disease-cohort-analysis-as-modified-primary-outcome-in-a-phase-iii-clinical-trial
#20
Gordon K Wilcock, Serge Gauthier, Giovanni B Frisoni, Jianping Jia, Jiri H Hardlund, Hans J Moebius, Peter Bentham, Karin A Kook, Bjoern O Schelter, Damon J Wischik, Charles S Davis, Roger T Staff, Vesna Vuksanovic, Trevor Ahearn, Luc Bracoud, Kohkan Shamsi, Ken Marek, John Seibyl, Gernot Riedel, John M D Storey, Charles R Harrington, Claude M Wischik
BACKGROUND: LMTM is being developed as a treatment for AD based on inhibition of tau aggregation. OBJECTIVES: To examine the efficacy of LMTM as monotherapy in non-randomized cohort analyses as modified primary outcomes in an 18-month Phase III trial in mild AD. METHODS: Mild AD patients (n = 800) were randomly assigned to 100 mg twice a day or 4 mg twice a day. Prior to unblinding, the Statistical Analysis Plan was revised to compare the 100 mg twice a day as monotherapy subgroup (n = 79) versus 4 mg twice a day as randomized (n = 396), and 4 mg twice a day as monotherapy (n = 76) versus 4 mg twice a day as add-on therapy (n = 297), with strong control of family-wise type I error...
November 17, 2017: Journal of Alzheimer's Disease: JAD
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