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Phase III trials

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https://www.readbyqxmd.com/read/28445097/phase-iib-randomized-double-blind-placebo-controlled-study-of-naldemedine-for-the-treatment-of-opioid-induced-constipation-in-patients-with-cancer
#1
Nobuyuki Katakami, Koji Oda, Katsunori Tauchi, Ken Nakata, Katsunori Shinozaki, Takaaki Yokota, Yura Suzuki, Masaru Narabayashi, Narikazu Boku
Purpose This randomized, double-blind, multicenter study aimed to determine the dose of naldemedine, a peripherally-acting μ-opioid receptor antagonist, for future trials by comparing the efficacy and safety of three doses of naldemedine versus placebo in patients with cancer and opioid-induced constipation. Methods Patients ≥ 18 years old with cancer, an Eastern Cooperative Oncology Group performance status ≤ 2, who had been receiving a stable regimen of opioid analgesics for ≥ 2 weeks, had at least one constipation symptom despite laxative use, and no more than five spontaneous bowel movements (SBMs) during the past 14 days, were randomly assigned (1:1:1:1) to oral, once-daily naldemedine 0...
April 26, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28443391/atazanavir-sulfate-cobicistat-for-the-treatment-of-hiv-infection
#2
Francisco Antunes
The life expectancy of patients living with HIV has increased significantly in the last two decades, as a result of the great progress in treatment of HIV infection. During this time, several drugs were developed to offer long-term benefits in terms of virologic efficacy, favourable tolerability and toxicity profiles. Pharmacokinetic boosting of protease inhibitors allows a higher genetic barrier, as few or no drug-resistant mutations are detected in patients with virologic failure. Areas covered: Atazanavir sulfate + cobicistat (ATV/c) was recently approved in the United States of America and in the European Union for the treatment of HIV-1 infection...
April 26, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28443384/biological-and-targeted-therapies-of-systemic-lupus-erythematosus-evidence-and-the-state-of-the-art
#3
Chi Chiu Mok
Systemic lupus erythematosus (SLE) is a multi-systemic disease characterized by an unpredictable disease course and periods of remission and flare, leading to organ damage and mortality. Novel biological agents are being developed (targeting the lymphocytes, accessory molecules and cytokines) that aim to enhance the therapeutic efficacy when combined with standard therapies. Areas covered: This article updates recent data on the use of biological and targeted therapies in SLE. Expert opinion: B cells remain the main target of development of novel therapeutics in SLE...
April 26, 2017: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/28443352/gff-mdi-for-the-improvement-of-lung-function-in-copd-a-look-at-the-pinnacle-1-and-pinnacle-2-data-and-beyond
#4
Klaus F Rabe
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death globally and incidence rates are continuing to rise. Long-acting bronchodilators are the foundation on which current pharmacological approaches to COPD management are built, with long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs) recommended across the spectrum of the disease continuum. Combining LAMAs and LABAs provides additional lung function improvements and relief of patient symptoms compared with either therapy alone...
April 26, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28443252/open-label-phase-ii-clinical-trial-in-75-patients-with-advanced-hepatocellular-carcinoma-receiving-daily-dose-of-tableted-liver-cancer-vaccine-hepcortespenlisimut-l
#5
Marina G Tarakanovskaya, Jigjidsuren Chinburen, Purev Batchuluun, Chogsom Munkhzaya, Genden Purevsuren, Dorjiin Dandii, Tsogkhuu Hulan, Dandii Oyungerel, Galyna A Kutsyna, Alan A Reid, Vika Borisova, Allen I Bain, Vichai Jirathitikal, Aldar S Bourinbaiar
BACKGROUND: An increasing number of studies is now devoted to immunotherapy of cancer. We evaluated the clinical benefit of hepcortespenlisimut-L (Hepko-V5 [formerly known as V5])-an oral therapeutic vaccine designated by the United States Food and Drug Administration (FDA) as an orphan drug for treatment of hepatocellular carcinoma (HCC). V5 was initially developed by us in 2002 to treat hepatitis B or C viral infections and liver cirrhosis. METHODS: The outcome of open-label Phase II trial of daily dose of V5 pill was analyzed retrospectively...
2017: Journal of Hepatocellular Carcinoma
https://www.readbyqxmd.com/read/28442915/efficacy-and-safety-outcomes-of-sofosbuvir-based-treatment-regimens-for-hepatitis-c-virus-infected-patients-with-or-without-cirrhosis-from-phase-iii-clinical-trials
#6
REVIEW
Young-Mo Yang, Eun Joo Choi
BACKGROUND: With the appearance of oral direct-acting antivirals (DAAs), the field of hepatitis C virus (HCV) treatment has been dramatically changed. This evolution makes possible for all oral treatments to be available for the treatment of HCV-infected patients. The aims of this review were to report the efficacy and safety of sofosbuvir (SOF)-based regimens for the treatment of patients with chronic HCV infection and to provide our clinical perspectives on these regimens. METHODS: A literature search of clinical studies published in PubMed and posted on ClinicalTrials...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28441966/maintenance-tegafur-uracil-versus-observation-following-an-adjuvant-oxaliplatin-based-regimen-in-patients-with-stage-iii-colon-cancer-after-radical-resection-study-protocol-for-a-randomized-controlled-trial
#7
Yung-Sung Yeh, Hsiang-Lin Tsai, Ching-Wen Huang, Po-Li Wei, Yung-Chuan Sung, Hsiu-Chih Tang, Jaw-Yuan Wang
BACKGROUND: We conducted a prospective randomized study of an adjuvant oxaliplatin-based regimen plus orally administered tegafur-uracil in patients with stage III colon cancer after radical resection to evaluate the feasibility of this drug combination in cancer clinical outcomes, acute toxicity, disease-free survival (DFS), and overall survival (OS) in Taiwan. METHODS/DESIGN: This is an open-label, randomized, comparative, double-arm, multicenter, phase III study to assess DFS, OS, and safety profiles of the aforementioned drug combination as maintenance therapy for 1 year in patients with stage III colon cancer after radical resection in Taiwan...
April 26, 2017: Trials
https://www.readbyqxmd.com/read/28441904/the-safety-of-ustekinumab-for-the-treatment-of-psoriatic-arthritis
#8
A López-Ferrer, A Laiz, L Puig
The cytokines interleukin (IL)-12 and IL-23 have been involved in the pathogenesis of psoriasis and psoriatic arthritis. Ustekinumab is a fully human monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23. Ustekinumab prevents the interaction of IL-12 and IL-23 binding to its receptor, blocking the T1 and T17 inflammatory pathways. Ustekinumab has been evaluated for the treatment of various chronic immune mediated diseases including psoriasis and psoriatic arthritis (PsA). Most of the data regarding the safety of ustekinumab come from the experience treating patients with psoriasis, but clinical trials have demonstrated its efficacy and safety in the treatment of both diseases...
April 25, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28441175/acceptability-and-use-of-a-dapivirine-vaginal-ring-in-a-phase-iii-trial
#9
Elizabeth T Montgomery, Ariane van der Straten, Miria Chitukuta, Krishnaveni Reddy, Kubashni Woeber, Millicent Atujuna, Linda-Gail Bekker, Juliane Etima, Teopista Nakyanzi, Ashley J Mayo, Ariana Katz, Nicole Laborde, Cynthia I Grossman, Lydia Soto-Torres, Thesla Palanee-Phillips, Jared M Baeten
BACKGROUND: The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring. METHOD: Qualitative study participants (n = 214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion...
May 15, 2017: AIDS
https://www.readbyqxmd.com/read/28441112/second-line-hormonal-therapy-for-men-with-chemotherapy-na%C3%A3-ve-castration-resistant-prostate-cancer-american-society-of-clinical-oncology-provisional-clinical-opinion
#10
Katherine S Virgo, Ethan Basch, D Andrew Loblaw, Tom Oliver, R Bryan Rumble, Michael A Carducci, Luke Nordquist, Mary-Ellen Taplin, Eric Winquist, Eric A Singer
Purpose ASCO provisional clinical opinions (PCOs) offer direction to the ASCO membership after publication or presentation of potential practice-changing data. This PCO addresses second-line hormonal therapy for chemotherapy-naïve men with castration-resistant prostate cancer (CRPC) who range from being asymptomatic with only biochemical evidence of CRPC to having documented metastases but minimal symptoms. Clinical Context The treatment goal for CRPC is palliation. Despite resistance to initial androgen deprivation therapy, most men respond to second-line hormonal therapies...
April 25, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28440320/a-review-of-pomegranate-in-prostate-cancer
#11
REVIEW
C J Paller, A Pantuck, M A Carducci
BACKGROUND: Preclinical studies showing that pomegranate juice and its components inhibit prostate cancer led to multiple clinical trials to determine whether pomegranate products could slow the growth of prostate cancer. This review summarizes the preclinical data and discusses the results of the clinical trials. METHODS: Trials targeted patients on active surveillance, neoadjuvant patients, patients with biochemical recurrence (BCR) following local therapy for prostate cancer, and patients with metastatic castration-resistant prostate cancer (mCRPC)...
April 25, 2017: Prostate Cancer and Prostatic Diseases
https://www.readbyqxmd.com/read/28439738/prospective-open-uncontrolled-phase-i-study-to-define-a-well-tolerated-dose-of-oral-artesunate-as-add-on-therapy-in-patients-with-metastatic-breast-cancer-artic-m33-2
#12
Cornelia von Hagens, Ingeborg Walter-Sack, Maren Goeckenjan, Julia Osburg, Brigitte Storch-Hagenlocher, Serkan Sertel, Michael Elsässer, Bjoern Andrew Remppis, Lutz Edler, Judith Munzinger, Thomas Efferth, Andreas Schneeweiss, Thomas Strowitzki
PURPOSE: The antimalarial drug artesunate (ART) is a promising candidate for cancer treatment as it displays anticancer effects in various models. While in short-term treatment of malaria, an excellent safety profile has been found for ART, the potential long-term treatment of cancer patients demands a phase I dose-finding clinical trial determining the daily ART dose which would be well tolerated as add-on therapy. METHODS: Patients with metastatic breast cancer were to receive either 100 or 150 or 200 mg oral ART daily as add-on to their guideline-based oncological therapy for a study period of four weeks with frequent clinical and laboratory monitoring until 4-8 weeks thereafter...
April 24, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28437190/consuming-a-ketogenic-diet-while-receiving-radiation-and-chemotherapy-for-locally-advanced-lung-cancer-and-pancreatic-cancer-the-university-of-iowa-experience-of-two-phase-1-clinical-trials
#13
Amir Zahra, Melissa A Fath, Emyleigh Opat, Kranti A Mapuskar, Sudershan K Bhatia, Daniel C Ma, Samuel N Rodman Iii, Travis P Snyders, Catherine A Chenard, Julie M Eichenberger-Gilmore, Kellie L Bodeker, Logan Ahmann, Brian J Smith, Sandy A Vollstedt, Heather A Brown, Taher Abu Hejleh, Gerald H Clamon, Daniel J Berg, Luke I Szweda, Douglas R Spitz, John M Buatti, Bryan G Allen
Ketogenic diets are low in carbohydrates and high in fat, which forces cells to rely more heavily upon mitochondrial oxidation of fatty acids for energy. Relative to normal cells, cancer cells are believed to exist under a condition of chronic mitochondrial oxidative stress that is compensated for by increases in glucose metabolism to generate reducing equivalents. In this study we tested the hypothesis that a ketogenic diet concurrent with radiation and chemotherapy would be clinically tolerable in locally advanced non-small cell lung cancer (NSCLC) and pancreatic cancer and could potentially exploit cancer cell oxidative metabolism to improve therapeutic outcomes...
April 24, 2017: Radiation Research
https://www.readbyqxmd.com/read/28437161/randomized-phase-iii-trial-of-trastuzumab-plus-capecitabine-with-or-without-pertuzumab-in-patients-with-human-epidermal-growth-factor-receptor-2-positive-metastatic-breast-cancer-who-experienced-disease-progression-during-or-after-trastuzumab-based-therapy
#14
Ander Urruticoechea, Mohammed Rizwanullah, Seock-Ah Im, Antonio Carlos Sánchez Ruiz, István Láng, Gianluca Tomasello, Hannah Douthwaite, Tanja Badovinac Crnjevic, Sarah Heeson, Jennifer Eng-Wong, Montserrat Muñoz
Purpose To assess the efficacy and safety of trastuzumab plus capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who experienced disease progression during or after trastuzumab-based therapy and received a prior taxane. Patients and Methods Patients were randomly assigned to arm A: trastuzumab 8 mg/kg → 6 mg/kg once every 3 weeks plus capecitabine 1,250 mg/m(2) twice a day (2 weeks on, 1 week off, every 3 weeks); or arm B: pertuzumab 840 mg → 420 mg once every 3 weeks plus trastuzumab at the same dose and schedule as arm A plus capecitabine 1,000 mg/m(2) on the same schedule as arm A...
April 24, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28436593/results-for-patients-with-sarcoma-not-otherwise-specified-and-other-diagnoses-than-ewing-sarcoma-treated-according-to-the-euro-ewing-99-trial
#15
Judith Amalie Frank, Andreas Ranft, Michael Paulussen, Heribert Juergens, Jarmila Kruseova, Sebastian Bauer, Felix Niggli, Peter Reichardt, Uta Dirksen
BACKGROUND: Euro-EWING 99 trial of the European Ewing tumor Working Initiative of National Groups (EE99) was an international phase III study in patients with Ewing sarcoma. The German Society of Pediatric Oncology and Hematology (GPOH) data center registered and followed patients with other diagnoses than Ewing sarcoma who were treated according to the EE99 protocol in an additional non-Ewing database. PROCEDURE: Data of 27 patients with other diagnoses than Ewing sarcoma treated according to the EE99 protocol were analyzed...
April 24, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28436538/longitudinal-magnetic-resonance-imaging-in-progressive-supranuclear-palsy-a-new-combined-score-for-clinical-trials
#16
Günter U Höglinger, Jakob Schöpe, Maria Stamelou, Jan Kassubek, Teodoro Del Ser, Adam L Boxer, Stefan Wagenpfeil, Hans-Jürgen Huppertz
BACKGROUND: Two recent, randomized, placebo-controlled phase II/III trials (clinicaltrials.gov: NCT01110720, NCT01049399) of davunetide and tideglusib in progressive supranuclear palsy (PSP) generated prospective, 1-year longitudinal datasets of high-resolution T1-weighted three-dimensional MRI. OBJECTIVE: The objective of this study was to develop a quantitative MRI disease progression measurement for clinical trials. METHODS: The authors performed a fully automated quantitative MRI analysis employing atlas-based volumetry and provide sample size calculations based on data collected in 99 PSP patients assigned to placebo in these trials...
April 24, 2017: Movement Disorders: Official Journal of the Movement Disorder Society
https://www.readbyqxmd.com/read/28436395/phase-iib-study-of-intranasal-glutathione-in-parkinson-s-disease
#17
Laurie K Mischley, Richard C Lau, Eric G Shankland, Timothy K Wilbur, Jeannie M Padowski
BACKGROUND: Reduced glutathione (GSH) is an endogenously synthesized tripeptide depleted early in the course of Parkinson's disease (PD) and GSH augmentation has been proposed as a therapeutic strategy in PD. OBJECTIVE: This Phase IIb study was designed to evaluate whether a Phase III study of intranasal GSH, (in)GSH, for symptomatic relief is warranted and to determine the most appropriate trial design for a disease-modification study. METHODS: This was a double-blind, placebo-controlled trial of 45 individuals with Hoehn & Yahr Stage 1-3 PD...
April 20, 2017: Journal of Parkinson's Disease
https://www.readbyqxmd.com/read/28436046/simulation-based-adjustment-after-exploratory-biomarker-subgroup-selection-in-phase-ii
#18
Heiko Götte, Marietta Kirchner, Martin Oliver Sailer, Meinhard Kieser
As part of the evaluation of phase II trials, it is common practice to perform exploratory subgroup analyses with the aim of identifying patient populations with a beneficial treatment effect. When investigating targeted therapies, these subgroups are typically defined by biomarkers. Promising results may lead to the decision to select the respective subgroup as the target population for a subsequent phase III trial. However, a selection based on a large observed treatment effect may potentially induce an upwards-bias leading to over-optimistic expectations on the success probability of the phase III trial...
April 24, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28435985/elucidating-the-a%C3%AE-42-anti-aggregation-mechanism-of-action-of-tramiprosate-in-alzheimer-s-disease-integrating-molecular-analytical-methods-pharmacokinetic-and-clinical-data
#19
Petr Kocis, Martin Tolar, Jeremy Yu, William Sinko, Soumya Ray, Kaj Blennow, Howard Fillit, John A Hey
BACKGROUND: Amyloid beta (Aβ) oligomers play a critical role in the pathogenesis of Alzheimer's disease (AD) and represent a promising target for drug development. Tramiprosate is a small-molecule Aβ anti-aggregation agent that was evaluated in phase III clinical trials for AD but did not meet the primary efficacy endpoints; however, a pre-specified subgroup analysis revealed robust, sustained, and clinically meaningful cognitive and functional effects in patients with AD homozygous for the ε4 allele of apolipoprotein E4 (APOE4/4 homozygotes), who carry an increased risk for the disease...
April 24, 2017: CNS Drugs
https://www.readbyqxmd.com/read/28435450/exome-sequencing-of-oral-squamous-cell-carcinoma-reveals-molecular-subgroups-and-novel-therapeutic-opportunities
#20
Shih-Chi Su, Chiao-Wen Lin, Yu-Fan Liu, Wen-Lang Fan, Mu-Kuan Chen, Chun-Ping Yu, Wei-En Yang, Chun-Wen Su, Chun-Yi Chuang, Wen-Hsiung Li, Wen-Hung Chung, Shun-Fa Yang
Oral squamous cell carcinoma (OSCC), an epithelial malignancy affecting a variety of subsites in the oral cavity, is prevalent in Asia. The survival rate of OSCC patients has not improved over the past decades due to its heterogeneous etiology, genetic aberrations, and treatment outcomes. Improvement in therapeutic strategies and tailored treatment options is an unmet need. To unveil the mutational spectrum, whole-exome sequencing of 120 OSCC from male individuals in Taiwan was conducted. Analyzing the contributions of the five mutational signatures extracted from the dataset of somatic variations identified four groups of tumors that were significantly associated with demographic and clinical features...
2017: Theranostics
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