keyword
MENU ▼
Read by QxMD icon Read
search

Phase III clinical trial

keyword
https://www.readbyqxmd.com/read/29473265/cytotoxic-t-lymphocyte-response-to-peptide-vaccination-predicts-survival-in-stage-iii-colorectal-cancer
#1
Junichiro Kawamura, Fumiaki Sugiura, Yasushi Sukegawa, Yasumasa Yoshioka, Jin-Ichi Hida, Shoichi Hazama, Kiyotaka Okuno
We previously reported a phase I clinical trial of a peptide vaccine ring finger protein 43 (RNF43) and 34-kDa translocase of the outer mitochondrial membrane (TOMM34) combined with uracil-tegafur (UFT)/LV for patients with metastatic colorectal cancer (CRC), and demonstrated the safety and immunological responsiveness of this combination therapy. In this study, we evaluated vaccination-induced immune responses to clarify the survival benefit of the combination therapy as adjuvant treatment. We enrolled 44 patients initially in an HLA-masked fashion...
February 23, 2018: Cancer Science
https://www.readbyqxmd.com/read/29472259/feasibility-of-a-multicentre-randomised-controlled-trial-of-laparoscopic-versus-open-colorectal-surgery-in-the-acute-setting-the-laces-feasibility-trial-protocol
#2
Deena Harji, Helen Marshall, Katie Gordon, Hannah Crow, Victoria Hiley, Dermot Burke, Ben Griffiths, Catherine Moriarty, Maureen Twiddy, John L O'Dwyer, Azmina Verjee, Julia Brown, Peter Sagar
INTRODUCTION: Acute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise...
February 22, 2018: BMJ Open
https://www.readbyqxmd.com/read/29471919/dupilumab-a-review-of-its-use-in-the-treatment-of-atopic-dermatitis
#3
Melinda J Gooderham, H Chih-Ho Hong, Panteha Eshtiaghi, Kim A Papp
Atopic dermatitis (AD) is a chronic, pruritic immune-mediated inflammatory dermatosis characterized by a T helper 2 (Th2) immune response phenotype and may be associated with systemic inflammation. Dupilumab is an interleukin 4 (IL-4) receptor α-antagonist that inhibits IL-4 and IL-13 signaling through blockade of the shared IL-4α subunit. Blockade of IL-4/13 is effective in reducing Th2 response. Dupilumab has recently been approved in the United States and Europe for the treatment of adult patients with moderate-to-severe AD...
March 2018: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/29470723/cyclin-dependent-kinase-4-6-inhibitors-as-first-line-treatment-for-post-menopausal-metastatic-hormone-receptor-positive-breast-cancer-patients-a-systematic-review-and-meta-analysis-of-phase-iii-randomized-clinical-trials
#4
Allan Ramos-Esquivel, Hellen Hernández-Steller, Marie-France Savard, Denis Ulises Landaverde
BACKGROUND: To compare the efficacy and toxicity of the combination of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and nonsteroidal aromatase inhibitors (AI) versus AI alone as first-line therapy for patients with advanced hormone receptor-positive breast cancer. MATERIALS AND METHODS: Phase III randomized clinical trials (RCT) were identified after a systematic review of electronic databases. A random-effect model was used to determine the pooled hazard ratio (HR) for progression-free survival (PFS) using the inverse-variance method...
February 22, 2018: Breast Cancer: the Journal of the Japanese Breast Cancer Society
https://www.readbyqxmd.com/read/29470101/ebselen-reversibly-inhibits-human-glutamate-dehydrogenase-at-the-catalytic-site
#5
Yanhong Jin, Di Li, Shiying Lu, Han Zhao, Zhao Chen, Wei Hou, Benfang Helen Ruan
Human glutamate dehydrogenase (GDH) plays an important role in neurological diseases, tumor metabolism, and hyperinsulinism-hyperammonemia syndrome (HHS). However, there are very few inhibitors known for human GDH. Recently, Ebselen was reported to crosslink with Escherichia coli GDH at the active site cysteine residue (Cys321), but the sequence alignment showed that the corresponding residue is Ala329 in human GDH. To investigate whether Ebselen could be an inhibitor for human GDH, we cloned and expressed an N-terminal His-tagged human GDH in E...
February 22, 2018: Assay and Drug Development Technologies
https://www.readbyqxmd.com/read/29468108/nivolumab-in-renal-cell-carcinoma-current-trends-and-future-perspectives
#6
REVIEW
Cesar E Ochoa, Richard W Joseph
Targeted agents form the backbone of most therapeutic strategies in advanced renal cell carcinoma (aRCC) but ultimately resistance develops and toxicity often leads to discontinuation of treatment, limiting the clinical benefits of these treatments. Nivolumab, a fully human IgG4 anti-PD-1 antibody, selectively blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2 and provides a novel therapy option for patients with aRCC. In 2015, the pivotal phase III study CheckMate 025 led to the Food and Drug Administration approval of nivolumab in patients with aRCC who had received prior anti-angiogenic therapy, and in 2017, the phase III study CheckMate 214 showed that combined immunotherapy with nivolumab plus ipilimumab resulted in greater objective response rate and prolonged progression-free survival when compared with sunitinib in intermediate- and poor-risk patients with previously untreated aRCC...
2018: Journal of Kidney Cancer and VHL
https://www.readbyqxmd.com/read/29467885/paclitaxel-plus-nedaplatin-vs-paclitaxel-plus-carboplatin-in-women-with-epithelial-ovarian-cancer-a-multi-center-randomized-open-label-phase-iii-trial
#7
Li Li, Qingqing Zhuang, Zeyi Cao, Rutie Yin, Yaping Zhu, Lirong Zhu, Xing Xie, Youzhong Zhang, Li Li, Qiang Wu, Jianhua Zheng, Qi Zhou, Xiaoping Li, Lingying Wu, Youji Feng, Changyu Wang
The multi-center, randomized, open-label, phase III trial discussed in the present study was performed to compare the clinical outcomes of nedaplatin (NDP) plus paclitaxel, and carboplatin (CBP) plus paclitaxel for the treatment of epithelial ovarian cancer (EOC). In the current study, 182 patients with International Federation of Gynecology and Obstetrics (FIGO) stage II-IV EOC were randomly assigned to receive NDP plus paclitaxel or CBP plus paclitaxel at 3-week intervals for a total of six courses. The primary endpoints were progression-free survival rate (PFS) and overall survival rate (OS)...
March 2018: Oncology Letters
https://www.readbyqxmd.com/read/29467027/quality-of-reporting-of-outcomes-in-phase-iii-studies-of-pulmonary-tuberculosis-a-systematic-review
#8
REVIEW
Laura Jayne Bonnett, Gie Ken-Dror, Geraint Rhys Davies
BACKGROUND: Despite more than 60 years of clinical trials, tuberculosis (TB) still causes a high global burden of mortality and morbidity. Treatment currently requires multiple drugs in combination, taken over a prolonged period. New drugs are needed to shorten treatment duration, prevent resistance and reduce adverse events. However, to improve on current methodology in drug development, a more complete understanding of the existing clinical evidence base is required. METHODS: A systematic review was undertaken to summarise outcomes reported in phase III trials of patients with newly diagnosed pulmonary TB...
February 21, 2018: Trials
https://www.readbyqxmd.com/read/29465266/cardiotoxicity-associated-with-carfilzomib-systematic-review-and-meta-analysis
#9
Chintan Shah, Rohit Bishnoi, Ankur Jain, Harini Bejjanki, Sican Xiong, Yu Wang, Fei Zou, Jan S Moreb
Carfilzomib is a second-generation proteasome inhibitor (PI) that is approved for patients with relapsed or refractory multiple myeloma (RRMM) who failed ≥1 prior lines of therapy. We performed a systematic review of carfilzomib literature with meta-analysis to determine cumulative incidence of cardiotoxicity. After the literature search, we included a total of 29 eligible phase I/II, phase II and phase III clinical trials which used carfilzomib. The cumulative incidence and overall odds ratios (OR) were calculated with random effect model, using 'R' software with metaphor package...
February 21, 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29464667/economic-evaluation-of-bevacizumab-for-treatment-of-platinum-resistant-recurrent-ovarian-cancer-in-canada
#10
Graeme Ball, Feng Xie, Jean-Eric Tarride
BACKGROUND: Ovarian cancer is a leading cause of cancer-related mortality. Although the disease is relatively rare, it carries a disproportionately large morbidity burden. OBJECTIVE: We conducted a cost-utility analysis from a Canadian public payer perspective to determine the cost effectiveness of bevacizumab, a newly available treatment option for recurrent ovarian cancer. METHODS: Using a 7-year time horizon, a three health-state cohort-based partitioned survival model was developed to assess the cost utility of bevacizumab plus chemotherapy (BEV) versus chemotherapy alone...
March 2018: PharmacoEconomics Open
https://www.readbyqxmd.com/read/29463549/androgen-deprivation-therapy-potentiates-the-efficacy-of-vascular-targeted-photodynamic-therapy-of-prostate-cancer-xenografts
#11
Kwanghee Kim, Philip A Watson, Souhil Lebdai, Sylvia Jebiwott, Alexander Somma, Stephen P La Rosa, Dipti Mehta, Katie S Murray, Hans G Lilja, David Ulmert, Sebastien Monette, Avigdor J Scherz, Jonathan Coleman
PURPOSE: WST11 vascular targeted photodynamic therapy (VTP) is a local ablation approach relying upon rapid, free radical-mediated destruction of tumor vasculature. A phase III trial showed that VTP significantly reduced disease progression when compared to active surveillance in patients with low-risk prostate cancer (PCa). The aim of this study was to identify a druggable pathway that could be combined with VTP to improve its efficacy and applicability to higher risk PCa tumors. EXPERIMENTAL DESIGN: Transcriptome analysis of VTP treated tumors (LNCaP-AR xenografts) was used to identify a candidate pathway for combination therapy...
February 20, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29462482/a-randomized-phase-iii-trial-of-adjuvant-s-1-therapy-vs-observation-alone-in-resected-biliary-tract-cancer-japan-clinical-oncology-group-study-jcog1202-ascot
#12
Kohei Nakachi, Masaru Konishi, Masafumi Ikeda, Junki Mizusawa, Junko Eba, Takuji Okusaka, Hiroshi Ishii, Haruhiko Fukuda, Junji Furuse
No standard adjuvant treatment has been established for patients with curatively resected biliary tract cancer. S-1 has been reported to show promising efficacy with mild toxicity profiles in patients with advanced biliary tract cancer, and adjuvant S-1 therapy has been demonstrated to provide survival benefit in patients with resected gastric cancer and pancreatic cancer. The aim of this open-label, multicenter, randomized Phase III trial is to confirm that adjuvant chemotherapy with S-1 would prolong overall survival in patients with resected biliary tract cancer...
February 15, 2018: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29461913/immunogenicity-and-safety-of-the-first-indigenously-developed-indian-tetravalent-influenza-vaccine-split-virion-in-healthy-adults-%C3%A2-18-years-of-age-a-randomized-multicenter-phase-ii-iii-clinical-trial
#13
Shrikant Sharma, Veer Bahadur Singh, Sanjay Kumar, Vipul Prajapati, Jitendra Patel, Rajesh Vukkala, Sanjay Kumar Jangid, Jayesh Sanmukhani, Gaurav Gupta, Pradip Patel, Ravindra Mittal, Reinhard Glueck
This phase II / III clinical trial was conducted to evaluate the immunogenicity and safety of the Tetravalent Influenza vaccine (Split virion) I.P. (TetIV) developed indigenously in the country for the first time by M/s Cadila Healthcare Limited, India containing two influenza A and two influenza B strains, one of each, Yamagata (B/Phuket) and Victoria (B/Brisbane) lineage and also compare it to that of an licensed seasonal Trivalent Influenza vaccine (TriIV) of Sanofi Pasteur India Private Limited, containing the two influenza A and only the Yamagata lineage (B/Phuket) strain...
February 20, 2018: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29459064/comparison-of-serum-bactericidal-and-antibody-titers-induced-by-two-haemophilus-influenzae-type-b-conjugate-vaccines-a-phase-iii-randomized-double-blind-study
#14
Yukihiro Akeda, Yuka Koizumi, Yohei Takanami, Shuji Sumino, Yumi Hattori, Kayoko Sugizaki, Nodoka Mitsuya, Kazunori Oishi
Haemophilus influenzae type b (Hib) conjugate vaccines have drastically reduced disease incidence worldwide. Protection against Hib infection has relied on the serum bactericidal activity (SBA) of antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate). However, licensure usually relies on measuring induction of antibodies to PRP as a surrogate for SBA. In a phase III clinical trial we compared a PRP-conjugate vaccine using the nontoxic diphtheria toxin mutant, CRM197 , as carrier protein with the licensed tetanus toxoid conjugate when administered subcutaneously as a three dose primary series in Japanese infants...
February 16, 2018: Vaccine
https://www.readbyqxmd.com/read/29458405/dacomitinib-potentiates-the-efficacy-of-conventional-chemotherapeutic-agents-via-inhibiting-the-drug-efflux-function-of-abcg2-in-vitro-and-in-vivo
#15
Xiaoran Guo, Kenneth K W To, Zhen Chen, Xiaokun Wang, Jianye Zhang, Min Luo, Fang Wang, Shirong Yan, Liwu Fu
BACKGROUND: ATP-binding cassette subfamily G member 2 (ABCG2), a member of the ABC transporter superfamily proteins, mediates multidrug resistance (MDR) by transporting substrate anticancer drugs out of cancer cells and decreasing their intracellular accumulation. MDR is a major hurdle to successful chemotherapy. A logical approach to overcome MDR is to inhibit the transporter. However, no safe and effective MDR inhibitor has been approved in the clinic. METHODS: The MTT assay was used to evaluate cell cytotoxicity and MDR reversal effect...
February 20, 2018: Journal of Experimental & Clinical Cancer Research: CR
https://www.readbyqxmd.com/read/29458401/efficacy-and-safety-of-ding-kun-dan-for-female-infertility-patients-with-predicted-poor-ovarian-response-undergoing-in-vitro-fertilization-intracytoplasmic-sperm-injection-study-protocol-for-a-randomized-controlled-trial
#16
Saihua Ma, Ruihong Ma, Tian Xia, Masoud Afnan, Xueru Song, Fengqin Xu, Guimin Hao, Fangfang Zhu, Jingpei Han, Zhimei Zhao
BACKGROUND: Women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who have a predicted poor ovarian response (POR) present a challenge for reproductive medicine specialists. Traditional Chinese medicine (TCM) is commonly used in China for such patients, in the belief that it will improve the ovarian response and ultimately increase pregnancy rates. However, there is a lack of high-quality evidence about the effect of TCM on improving ovarian response in such patients...
February 20, 2018: Trials
https://www.readbyqxmd.com/read/29458400/towards-an-appropriate-framework-to-facilitate-responsible-inclusion-of-pregnant-women-in-drug-development-programs
#17
Kit C B Roes, Indira S E van der Zande, Maarten van Smeden, Rieke van der Graaf
Evidence-based treatment for pregnant women will ultimately require research conducted in the population of pregnant women. Currently, few scholars have addressed the issue of responsible inclusion of pregnant women in drug research. Because of additional risks associated with including pregnant women in drug research and the altered ways in which drugs are processed by the pregnant body, pregnant women cannot be treated as an ordinary subgroup in the various phases of drug development. Instead, responsible inclusion of pregnant women requires careful design and planning of research for pregnant women specifically...
February 20, 2018: Trials
https://www.readbyqxmd.com/read/29458237/randomized-open-label-phase-iii-trial-of-irinotecan-plus-capecitabine-versus-capecitabine-monotherapy-in-patients-with-metastatic-breast-cancer-previously-treated-with-anthracycline-and-taxane-proceed-trial-kcsg-br-11-01
#18
In Hae Park, Seock-Ah Im, Kyung Hae Jung, Joo Hyuk Sohn, Yeon Hee Park, Keun Seok Lee, Sung Hoon Sim, Kyong-Hwa Park, Jee Hyun Kim, Byung Ho Nam, Hee-Jun Kim, Tae-Yong Kim, Kyung-Hun Lee, Sung-Bae Kim, Jin-Hee Ahn, Suee Lee, Jungsil Ro
Purpose: We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). Materials and Methods: A total of 221 patients were randomly assigned to irinotecan (80 mg/m2, days 1 and 8) and capecitabine (1,000 mg/m2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m2 twice a day, days 1-14) every 3 weeks...
February 14, 2018: Cancer Research and Treatment: Official Journal of Korean Cancer Association
https://www.readbyqxmd.com/read/29455421/impact-of-baseline-characteristics-on-outcomes-of-advanced-hcc-patients-treated-with-sorafenib-a-secondary-analysis-of-a-phase-iii-study
#19
Omar Abdel-Rahman
BACKGROUND: The current study aims to investigate the impact of baseline characteristics on the outcomes of sorafenib-treated advanced Hepatocellular carcinoma (HCC) patients in the setting of a clinical trial. METHODS: This is a secondary analysis of the comparator arm (sorafenib arm) of the NCT00699374 study which is a phase III multicenter study conducted between 2008 and 2010. The univariate probability of overall and progression-free survival was assessed among different patient subsets through Kaplan-Meier analysis and log-rank testing...
February 17, 2018: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/29451447/peripheral-nerve-grafts-implanted-into-the-substantia-nigra-in-patients-with-parkinson-s-disease-during-deep-brain-stimulation-surgery-1-year-follow-up-study-of-safety-feasibility-and-clinical-outcome
#20
Craig G van Horne, Jorge E Quintero, John T Slevin, Amelia Anderson-Mooney, Julie A Gurwell, Andrew S Welleford, John R Lamm, Renee P Wagner, Greg A Gerhardt
OBJECTIVE Currently, there is no treatment that slows or halts the progression of Parkinson's disease. Delivery of various neurotrophic factors to restore dopaminergic function has become a focus of study in an effort to fill this unmet need for patients with Parkinson's disease. Schwann cells provide a readily available source of such factors. This study presents a 12-month evaluation of safety and feasibility, as well as the clinical response, of implanting autologous peripheral nerve grafts into the substantia nigra of patients with Parkinson's disease at the time of deep brain stimulation (DBS) surgery...
February 16, 2018: Journal of Neurosurgery
keyword
keyword
7252
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"