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Phase III clinical trial cancer

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https://www.readbyqxmd.com/read/27910704/the-safety-of-nivolumab-for-the-treatment-of-advanced-non-small-cell-lung-cancer
#1
Giulio Metro, Biagio Ricciuti, Marta Brambilla, Sara Baglivo, Irene Soli, Elisa Minenza, Giulia Costanza Leonardi, Alessandro D'Arpino, Daniela Colabrese, Marco Tazza, Daniela Zicari, Vincenzo Minotti, Rita Chiari
Immune checkpoint blockaders (ICBs) act by unbalancing the immune system, thus favoring the development of an immune-mediated antitumor effect. ICBs targeting the programmed cell death receptor-1 (PD-1) have recently been investigated in a number of advanced tumors, including non-small cell lung cancer (NSCLC). Nivolumab, a fully human IgG4 kappa directed against PD-1, has been the first ICB to be approved for second-line treatment of advanced NSCLC. Areas covered: In this review we focus on the clinical development of nivolumab for the treatment of advanced NSCLC, with an emphasis on its safety profile...
December 2, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27902583/adverse-events-risk-associated-with-anti-vegfr-agents-in-the-treatment-of-advanced-nonsmall-cell-lung-cancer-a-meta-analysis
#2
Biao Gu, WenChuang Gao, HongJun Chu, Jian Gao, Zhi Fu, Hui Ding, JunJie Lv, QingQuan Wu
To perform this meta-analysis, we investigated the risk of the most clinically relevant adverse events related to antivascular endothelial growth factor receptor (VEGFR) agents in advanced nonsmall-cell lung cancer (NSCLC).A comprehensive literature search for studies published up to October 2015 was performed. Prospective randomized controlled phase II/III clinical trials that comparing therapy with or without anti-VEGFR agents for advanced NSCLC were included for analysis. Summary relative risk (RR) and 95% confidence intervals (CIs) were calculated using random effects or fixed effects according to the heterogeneity among included trials...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27898364/liquid-chromatography-tandem-mass-spectrometry-assay-for-the-quantification-of-niraparib-and-its-metabolite-m1-in-human-plasma-and-urine
#3
L van Andel, Z Zhang, S Lu, V Kansra, S Agarwal, L Hughes, M M Tibben, A Gebretensae, H Rosing, J H M Schellens, J H Beijnen
Niraparib (MK-4827) is a novel poly(ADP-Ribose) polymerase (PARP) inhibitor currently investigated in phase III clinical trials to treat cancers. The development of a new drug includes the characterisation of absorption, metabolism and excretion (AME) of the compound. AME studies are a requirement of regulatory agencies and for this purpose bioanalytical assays are essential. This article describes the development and validation of a bioanalytical assay for niraparib and its carboxylic acid metabolite M1 in human plasma and urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS)...
November 19, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/27896440/a-phase-iii-open-label-randomized-multicenter-controlled-trial-of-oral-versus-intravenous-treosulfan-in-heavily-pretreated-recurrent-ovarian-cancer-a-study-of-the-north-eastern-german-society-of-gynecological-oncology-noggo
#4
Jalid Sehouli, Oliver Tomè, Desislava Dimitrova, Oumar Camara, Ingo Bernhard Runnebaum, Hans Werner Tessen, Beate Rautenberg, Radoslav Chekerov, Mustafa Zelal Muallem, Michael Patrick Lux, Tanja Trarbach, Gerald Gitsch
OBJECTIVE: In recurrent ovarian cancer (ROC), there is a high demand on effective therapies with a mild toxicity profile. Treosulfan is an alkylating agent approved as oral (p.o.) and intravenous (i.v.) formulation for the treatment of recurrent ovarian cancer. Data on safety and efficacy for either formulation are rare. For the first time we conducted a randomized phase III study comparing both formulations in women with ROC. METHODS: Patients having received at least two previous lines of chemotherapy were randomly assigned to one of two treatment arms: treosulfan i...
November 28, 2016: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/27894673/treatment-related-death-in-cancer-patients-treated-with-immune-checkpoint-inhibitors-a-systematic-review-and-meta-analysis
#5
O Abdel-Rahman, D Helbling, J Schmidt, U Petrausch, A Giryes, A Mehrabi, O Schöb, M Mannhart, H Oweira
AIMS: We carried out a meta-analysis to determine the risk of treatment-related death associated with immune checkpoint inhibitor use in cancer patients. MATERIALS AND METHODS: We examined data from the Medline and Google Scholar databases. We also examined original studies and review articles for cross-references. Eligible studies included randomised phase II and phase III trials of patients with cancer treated with ipilimumab, pembrolizumab; nivolumab; tremelimumab and atezolizumab...
November 25, 2016: Clinical Oncology: a Journal of the Royal College of Radiologists
https://www.readbyqxmd.com/read/27893535/cytoplasmic-hur-status-predicts-disease-free-survival-in-resected-pancreatic-cancer-a-post-hoc-analysis-from-the-international-phase-iii-espac-3-clinical-trial
#6
Talar Tatarian, Wei Jiang, Benjamin E Leiby, Amanda Grigoli, Masaya Jimbo, Nooreen Dabbish, John P Neoptolemos, William Greenhalf, Eithne Costello, Paula Ghaneh, Christopher Halloran, Daniel Palmer, Markus Buchler, Charles J Yeo, Jordan M Winter, Jonathan R Brody
OBJECTIVES: We tested cytoplasmic HuR (cHuR) as a predictive marker for response to chemotherapy by examining tumor samples from the international European Study Group of Pancreatic Cancer-3 trial, in which patients with resected pancreatic ductal adenocarcinoma (PDA) received either gemcitabine (GEM) or 5-fluorouracil (5-FU) adjuvant monotherapy. BACKGROUND: Previous studies have implicated the mRNA-binding protein, HuR (ELAVL1), as a predictive marker for PDA treatment response in the adjuvant setting...
November 23, 2016: Annals of Surgery
https://www.readbyqxmd.com/read/27892773/real-world-data-on-nivolumab-treatment-of-non-small-cell-lung-cancer
#7
O T Brustugun, M Sprauten, Å Helland
BACKGROUND: Checkpoint inhibitors have proven effectiveness in clinical trials for non-small cell lung cancer (NSCLC) patients, but if this is congruent with routine patient care is discussed. We present real-world experience with the PD1-inhibitor nivolumab in NSCLC. PATIENTS AND METHODS: Patients with NSCLC were considered eligible for nivolumab treatment after one or more lines of chemotherapy, and when in reasonable performance status (PS) [Eastern Cooperative Oncology Group (ECOG) < 3]...
November 28, 2016: Acta Oncologica
https://www.readbyqxmd.com/read/27891294/prevalence-and-clinical-impact-of-cachexia-in-chronic-illness-in-europe-usa-and-japan-facts-and-numbers-update-2016
#8
EDITORIAL
Stephan von Haehling, Markus S Anker, Stefan D Anker
Cachexia is a serious clinical consequence of almost all chronic diseases when reaching advanced stages. Its prevalence ranges from 5-15% in end-stage chronic heart failure to 50-80% in advanced malignant cancer. Cachexia is also frequently occurring in patients with chronic kidney disease, chronic obstructive pulmonary disease (COPD) or neurological diseases, and rheumatoid arthritis. Mortality rates of patients with cachexia range from 15-25% per year in severe COPD through 20-40% per year in patients with chronic heart failure or chronic kidney disease to 20-80% in cancer cachexia...
December 2016: Journal of Cachexia, Sarcopenia and Muscle
https://www.readbyqxmd.com/read/27889780/targeted-treatment-of-esophagogastric-cancer
#9
Hans-Georg Kopp, Ralf-Dieter Hofheinz
Adenocarcinoma of the esophagogastric junction (EGJ) and stomach remains one of the most common causes of cancer-related death worldwide. Although there is increasing data on the mutational landscape of esophagogastric cancer, phase III trials often yield negative results, and there is a paucity of approved targeted agents. For the time being, the subset of patients carrying HER2-positive metastatic tumors can receive trastuzumab in addition to chemotherapy. Furthermore, ramucirumab has been found to be active both as a single agent and in combination with paclitaxel...
2016: Oncology Research and Treatment
https://www.readbyqxmd.com/read/27883925/factors-associated-with-failure-of-oncology-drugs-in-late-stage-clinical-development-a-systematic-review
#10
REVIEW
Denis L Jardim, Eric S Groves, Philip P Breitfeld, Razelle Kurzrock
BACKGROUND: We aimed to describe the reasons for failure of experimental anticancer drugs in late-stage clinical development. MATERIAL AND METHODS: We searched the PharmaProjects database (https://citeline.com/products/pharmaprojects/) for anticancer drugs discontinued between 01/01/2009 and 06/30/2014. Drug programs that reached phase III trials, but never gained Food and Drug Administration (FDA) approval were compared to 37 anti-cancer drugs achieving FDA approval in this time period...
November 4, 2016: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/27876603/canadian-phase-iii-randomized-trial-of-stereotactic-body-radiotherapy-versus-conventionally-hypofractionated-radiotherapy-for-stage-i-medically-inoperable-non-small-cell-lung-cancer-rationale-and-protocol-design-for-the-ontario-clinical-oncology-group-ocog
#11
Anand Swaminath, Marcin Wierzbicki, Sameer Parpia, James R Wright, Theodoros K Tsakiridis, Gordon S Okawara, Vijayananda Kundapur, Alexis Bujold, Naseer Ahmed, Khalid Hirmiz, Elizabeth Kurien, Edith Filion, Zsolt Gabos, Sergio Faria, Alexander V Louie, Timothy Owen, Elaine Wai, Kevin Ramchandar, Elisa K Chan, Jim Julian, Kathryn Cline, Timothy J Whelan
We describe a Canadian phase III randomized controlled trial of stereotactic body radiotherapy (SBRT) versus conventionally hypofractionated radiotherapy (CRT) for the treatment of stage I medically inoperable non-small-cell lung cancer (OCOG-LUSTRE Trial). Eligible patients are randomized in a 2:1 fashion to either SBRT (48 Gy in 4 fractions for peripherally located lesions; 60 Gy in 8 fractions for centrally located lesions) or CRT (60 Gy in 15 fractions). The primary outcome of the study is 3-year local control, which we hypothesize will improve from 75% with CRT to 87...
October 3, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/27857020/surrogate-endpoints-in-second-line-trials-of-targeted-agents-in-metastatic-colorectal-cancer-a-literature-based-systematic-review-and-meta-analysis
#12
Chiara Cremolini, Carlotta Antoniotti, Filippo Pietrantonio, Rosa Berenato, Marco Tampellini, Chiara Baratelli, Lisa Salvatore, Federica Marmorino, Beatrice Borelli, Federico Nichetti, Paolo Bironzo, Cristina Sonetto, Maria Di Bartolomeo, Filippo de Braud, Fotios Loupakis, Alfredo Falcone, Massimo Di Maio
Purpose: To evaluate progression-free survival (PFS) and objective response rate (ORR) as surrogate endpoints of overall survival (OS) in modern clinical trials investigating the efficacy of targeted agents in the second-line treatment of metastatic colorectal cancer (mCRC). Materials and Methods: A systematic search of literature pertaining to randomized phase II and III trials evaluating targeted agents as second-line treatments for mCRC was performed. The strength of the correlation between both PFS and ORR and OS was assessed based on the Pearson's correlation coefficient (R) and the coefficient of determination (R2)...
November 15, 2016: Cancer Research and Treatment: Official Journal of Korean Cancer Association
https://www.readbyqxmd.com/read/27855622/the-role-of-the-antiangiogenetic-ramucirumab-in-the-treatment-of-advanced-non-small-cell-lung-cancer
#13
Paolo Maione, Assunta Sgambato, Francesca Casaluce, Paola Claudia Sacco, Giuseppe Santabarbara, Antonio Rossi, Cesare Gridelli
Angiogenesis is one of the most important phenomena sustaining tumor development and metastatization, including for non small cell lung cancer (NSCLC). A dominant role in angiogenesis is played by the vascular endothelial growth factor (VEGF) and its signalling pathway. Ramucirumab, is a fully human immunoglobulin G1 monoclonal antibody that binds to the extracellular domain of the VEGF receptor-2 (VEGFR-2) with high specificity and affinity blocking the interaction of VEGFR-2 and VEGF ligands, thus inhibiting their signaling pathways and the consequential endothelial proliferation and migration...
November 18, 2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27852698/modifying-the-clinical-research-infrastructure-at-a-dedicated-clinical-trials-unit-assessment-of-trial-development-activation-and-participant-accrual
#14
Chad Tang, Kenneth R Hess, Dwana Sanders, Suzanne E Davis, Aman U Buzdar, Razelle Kurzrock, J Jack Lee, Funda Meric-Bernstam, David S Hong
PURPOSE: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center and analyzed their effects on the trial activation timeline and enrollment. EXPERIMENTAL DESIGN: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database we identified 2,261 activated phase I-III trials; 221 were done at the ICT...
November 16, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/27846725/-non-small-cell-lung-cancer-from-immunobiology-to-immunotherapy
#15
O Bílek, L Bohovicová, R Demlová, A Poprach, R Lakomý, L Zdražilová-Dubská
BACKGROUND: The treatment of early or locally advanced stages of non-small cell lung cancer (NSCLC) is based on surgical resection or radiotherapy. Metastatic disease is always incurable, treatment is palliative, systemic based on chemotherapy or target therapy. NSCLC is the most common cause of cancer-related death worldwide, and new therapeutic approaches are needed. Based on the emerging data on the role of immune system in shaping of tumor outbreak and outcome, immunotherapy is currently in the center of interest of cancer research and therapy of solid cancers including NSCLC...
2016: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/27843586/inter-institutional-heterogeneity-in-outcomes-of-chemotherapy-for-metastatic-gastric-cancer-correlative-study-in-the-jcog9912-phase-iii-trial
#16
Y Kurokawa, N Boku, T Yamaguchi, A Ohtsu, J Mizusawa, K Nakamura, H Fukuda
BACKGROUND: The standard chemotherapy regimen for gastric cancer has been established by several phase III trials. However, few studies have evaluated inter-institutional heterogeneity in randomised trials; such research may assure the generalisability of the results and also the reliability of the study group itself. PATIENTS AND METHODS: The Japan Clinical Oncology Group (JCOG)9912 phase III trial compared irinotecan plus cisplatin and S-1 alone with fluorouracil alone for metastatic gastric cancer, and finally demonstrated the non-inferiority of S-1 alone with respect to overall survival (OS)...
2016: ESMO Open
https://www.readbyqxmd.com/read/27843579/a-prospective-clinical-trial-to-assess-lapatinib-effects-on-cutaneous-squamous-cell-carcinoma-and-actinic-keratosis
#17
D Jenni, M B Karpova, B Mühleisen, J Mangana, J Dreier, J Hafner, R Dummer
BACKGROUND: Antiepidermal growth factor receptor (EGFR)-targeted therapy is widely used in many epithelial cancer types. We investigated lapatinib effects on cutaneous squamous cell carcinoma (cSCC) scheduled for resection and in coexisting precursor lesions (actinic keratosis (AK) and Bowen's disease (BD)) in a phase 2 mode of action clinical trial including a histological workup of the cSCC. PATIENTS AND METHODS: We initiated a prospective single-centre, open-label, non-controlled clinical study with translational intentions to investigate changes in size and histopathological features in cSCC after a 14-day period of neoadjuvant lapatinib therapy at a dose of 1500 mg/day prior to surgery, to quantify the impact on AK and BD in the same patient after 56 days and to evaluate the tolerability in patients with cSCC and precursor lesions...
2016: ESMO Open
https://www.readbyqxmd.com/read/27843208/immunotherapy-in-metastatic-prostate-cancer
#18
REVIEW
Susan F Slovin
INTRODUCTION: Prostate cancer remains a challenge as a target for immunological approaches. The approval of the first cell-based immune therapy, Sipuleucel-T for prostate cancer introduced prostate cancer as a solid tumor with the potential to be influenced by the immune system. METHODS: We reviewed articles on immunological management of prostate cancer and challenges that lie ahead for such strategies. RESULTS: Treatments have focused on the identification of novel cell surface antigens thought to be unique to prostate cancer...
October 2016: Indian Journal of Urology: IJU: Journal of the Urological Society of India
https://www.readbyqxmd.com/read/27830967/the-european-society-for-medical-oncology-magnitude-of-clinical-benefit-scale-esmo-mcbs-applied-to-pivotal-phase-iii-randomized-controlled-trials-of-tyrosine-kinase-inhibitors-in-first-line-for-advanced-non-small-cell-lung-cancer-with-activating-epidermal-growth
#19
Jacopo Giuliani, Andrea Remo, Andrea Bonetti
To examine the magnitude of the clinical benefit from first-line tyrosine kinase inhibitors (TKIs) advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR)-mutations. Areas covered: The present evaluation was restricted to pivotal phase III RCTs in first-line for advanced NSCLC with activating EGFR-mutations. We have subsequently applied the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) to the above pivotal phase III RCTs, to derive a relative ranking of the magnitude of clinically meaningful benefit...
November 21, 2016: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/27829278/systemic-therapy-for-biliary-cancers
#20
Emmet Jordan, Ghassan K Abou-Alfa, Maeve A Lowery
Biliary tract cancers represent an uncommon, heterogenous malignant group of tumors that include gallbladder cancers (GBC) and cholangiocarcinomas that are frequently detected in the locally advanced or metastatic setting. The randomized phase III ABC-02 trial established the combination regimen of cisplatin plus gemcitabine as standard of care therapy. Nevertheless, despite prior and subsequent attempts utilizing a variety of treatment strategies clinical outcomes for these cancers remains disappointing, necessitating the innate call for improvements in treatment approaches...
October 2016: Chinese Clinical Oncology
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