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https://www.readbyqxmd.com/read/29223745/buparlisib-plus-fulvestrant-in-postmenopausal-women-with-hormone-receptor-positive-her2-negative-advanced-breast-cancer-progressing-on-or-after-mtor-inhibition-belle-3-a-randomised-double-blind-placebo-controlled-phase-3-trial
#1
Angelo Di Leo, Stephen Johnston, Keun Seok Lee, Eva Ciruelos, Per E Lønning, Wolfgang Janni, Ruth O'Regan, Marie-Ange Mouret-Reynier, Dimitar Kalev, Daniel Egle, Tibor Csőszi, Roberto Bordonaro, Thomas Decker, Vivianne C G Tjan-Heijnen, Sibel Blau, Alessio Schirone, Denis Weber, Mona El-Hashimy, Bharani Dharan, Dalila Sellami, Thomas Bachelot
BACKGROUND: Activation of the PI3K/AKT/mTOR pathway occurs frequently in breast cancer that is resistant to endocrine therapy. Approved mTOR inhibitors effectively inhibit cell growth and proliferation but elicit AKT phosphorylation via a feedback activation pathway, potentially leading to resistance to mTOR inhibitors. We evaluated the efficacy and safety of buparlisib plus fulvestrant in patients with advanced breast cancer who were pretreated with endocrine therapy and mTOR inhibitors...
December 6, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29223478/phase-ii-trial-of-veliparib-in-patients-with-previously-treated-brca-mutated-pancreas-ductal-adenocarcinoma
#2
Maeve A Lowery, David P Kelsen, Marinela Capanu, Sloane C Smith, Jonathan W Lee, Zsofia K Stadler, Malcolm J Moore, Hedy L Kindler, Talia Golan, Amiel Segal, Hannah Maynard, Ellen Hollywood, MaryEllen Moynahan, Erin E Salo-Mullen, Richard Kinh Gian Do, Alice P Chen, Kenneth H Yu, Laura H Tang, Eileen M O'Reilly
PURPOSE: BRCA-associated cancers have increased sensitivity to poly(ADP-ribose) polymerase inhibitors (PARPis). This single arm, non-randomised, multicentre phase II trial evaluated the response rate of veliparib in patients with previously treated BRCA1/2- or PALB2-mutant pancreatic adenocarcinoma (PDAC). METHODS: Patients with stage III/IV PDAC and known germline BRCA1/2 or PALB2 mutation, 1-2 lines of treatment, Eastern Cooperative Oncology Group 0-2, were enrolled...
December 7, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29223441/edoxaban-for-the-management-of-elderly-japanese-patients-with-atrial-fibrillation-ineligible-for-standard-oral-anticoagulant-therapies-rationale-and-design-of-the-eldercare-af-study
#3
Ken Okumura, Gregory Y H Lip, Masaharu Akao, Kimihiko Tanizawa, Masayuki Fukuzawa, Kenji Abe, Masahiro Akishita, Takeshi Yamashita
Edoxaban-a non-vitamin K antagonist oral anticoagulant (NOAC)- 60-mg and 30-mg once-daily dose regimens are noninferior versus well-managed warfarin for the prevention of stroke or systemic embolic events (SEE) with less major bleeding in patients with nonvalvular atrial fibrillation (NVAF). There are no published data from phase 3 clinical trials specifically evaluating the use of NOACs in elderly NVAF patients, especially those considered ineligible for available oral anticoagulants. The Edoxaban Low-Dose for EldeR CARE AF patients (ELDERCARE-AF) study is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study that will compare the safety and efficacy of once-daily edoxaban 15 mg versus placebo in Japanese patients with NVAF ≥80 years of age who are considered ineligible for standard oral anticoagulant therapy...
December 2017: American Heart Journal
https://www.readbyqxmd.com/read/29223019/are-pathological-high-risk-features-in-locally-advanced-rectal-cancer-a-useful-selection-tool-for-adjuvant-chemotherapy
#4
Marloes Swets, Peter J K Kuppen, Erik J Blok, Hans Gelderblom, Cornelis J H van de Velde, Iris D Nagtegaal
BACKGROUND: Several histological high-risk factors are used as an indication for adjuvant therapy in stage II colon cancer. Those and other factors, including lymphatic invasion, perineural invasion (PNI), venous invasion and tumour budding are associated with decreased outcome. In this study, we evaluated the prognostic and predictive values of these biomarkers in a cohort of rectal cancer patients. MATERIALS AND METHODS: The trial-based cohort consisted of 221npTNM stage II-III rectal cancer patients, included in the PROCTOR/SCRIPT trial, a multicentre randomised phase III trial...
December 6, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29222604/model-based-analysis-of-the-heterogeneity-in-the-tumour-size-dynamics-differentiates-vemurafenib-dabrafenib-and-trametinib-in-metastatic-melanoma
#5
Hitesh B Mistry, David Orrell, Raluca Eftimie
PURPOSE: Explore the heterogeneity in dynamics of tumour response to vemurafenib, dabrafenib and trametinib using routinely collected clinical trial imaging data. METHODS: Time-series imaging data from the phase III studies of vemurafenib, dabrafenib and trametinib were collected through a data repository. A mathematical model based on basic mechanisms of tumour growth was placed within a statistical modelling framework to analyse the data. RESULTS: The analysis revealed: (1) existence of homogeneity in drug response and resistance development within a patient; (2) tumour shrinkage rate does not relate to rate of resistance development; (3) vemurafenib and dabrafenib, two BRAF inhibitors, have different variability in tumour shrinkage rates...
December 8, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29222310/novel-alternate-hemostatic-agents-for-patients-with-inhibitors-beyond-bypass-therapy
#6
REVIEW
Margaret V Ragni
Inhibitor formation is among the most severe complications of hemophilia treatment. With a cumulative incidence of ∼30% in those with severe hemophilia A and ∼3% in those with severe hemophilia B, inhibitors are caused by a T-cell response directed against infused coagulation factor; these inhibitors neutralize factor VIII or IX activity and disrupt normal hemostasis. Inhibitor patients become unresponsive to standard factor treatment and, as an alternative, use bypass treatment (eg, recombinant factor VIIa or factor VIII inhibitor bypass activity)...
December 8, 2017: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/29221491/a-phase-iii-randomized-trial-of-gantenerumab-in-prodromal-alzheimer-s-disease
#7
Susanne Ostrowitzki, Robert A Lasser, Ernest Dorflinger, Philip Scheltens, Frederik Barkhof, Tania Nikolcheva, Elizabeth Ashford, Sylvie Retout, Carsten Hofmann, Paul Delmar, Gregory Klein, Mirjana Andjelkovic, Bruno Dubois, Mercè Boada, Kaj Blennow, Luca Santarelli, Paulo Fontoura
BACKGROUND: Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the SCarlet RoAD trial, we assessed the efficacy and safety of gantenerumab in prodromal Alzheimer's disease (AD). METHODS: In this randomized, double-blind, placebo-controlled phase III study, we investigated gantenerumab over 2 years. Patients were randomized to gantenerumab 105 mg or 225 mg or placebo every 4 weeks by subcutaneous injection...
December 8, 2017: Alzheimer's Research & Therapy
https://www.readbyqxmd.com/read/29221445/study-protocol-of-hgcsg1404-snow-study-a-phase-i-ii-trial-of-combined-chemotherapy-of-s-1-nab-paclitaxel-and-oxaliplatin-administered-biweekly-to-patients-with-advanced-gastric-cancer
#8
Yasuyuki Kawamoto, Yoshito Komatsu, Satoshi Yuki, Kentaro Sawada, Tetsuhito Muranaka, Kazuaki Harada, Hiroshi Nakatsumi, Hiraku Fukushima, Atsushi Ishiguro, Masayoshi Dazai, Kazuteru Hatanaka, Michio Nakamura, Ichiro Iwanaga, Minoru Uebayashi, Susumu Sogabe, Yoshimitsu Kobayashi, Takuto Miyagishima, Kota Ono, Naoya Sakamoto, Yuh Sakata
BACKGROUND: In Japan, S-1 plus cisplatin (SP) regimen has become a standard therapy for patients with advanced gastric cancer. Moreover, the S-1 plus oxaliplatin regimen is now a standard treatment. Nab-paclitaxel was developed for chemotherapy of gastric cancer in Japanese clinical practice. Nab-paclitaxel, created with albumin-bound paclitaxel particles, has high transferability to tumour tissues and does not cause hypersensitivity reactions because of a different chemical composition compared with docetaxel and paclitaxel...
December 8, 2017: BMC Cancer
https://www.readbyqxmd.com/read/29220542/safety-and-efficacy-of-apremilast-through-104-weeks-in-patients-with-moderate-to-severe-psoriasis-who-continued-on-apremilast-or-switched-from-etanercept-treatment-findings-from-the-liberate-study
#9
K Reich, M Gooderham, A Bewley, L Green, J Soung, R Petric, J Marcsisin, J Cirulli, R Chen, V Piguet
BACKGROUND: Apremilast, an oral phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate to severe psoriasis. OBJECTIVE: To evaluate long-term efficacy and safety of apremilast in biologic-naive patients with moderate to severe plaque psoriasis and safety of switching from etanercept to apremilast in the phase 3b LIBERATE trial. METHODS: Two hundred fifty patients were randomized to placebo, apremilast 30 mg BID, or etanercept 50 mg QW through Week 16; thereafter, all patients continued or switched to apremilast through Week 104 (extension phase)...
December 8, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/29220295/once-a-week-versus-once-every-3-weeks-cisplatin-chemoradiation-for-locally-advanced-head-and-neck-cancer-a-phase-iii-randomized-noninferiority-trial
#10
Vanita Noronha, Amit Joshi, Vijay Maruti Patil, Jaiprakash Agarwal, Sarbani Ghosh-Laskar, Ashwini Budrukkar, Vedang Murthy, Tejpal Gupta, Anil K D'Cruz, Shripad Banavali, Prathamesh S Pai, Pankaj Chaturvedi, Devendra Chaukar, Nikhil Pande, Arun Chandrasekharan, Vikas Talreja, Dilip Harindran Vallathol, Vijayalakshmi Mathrudev, Aparna Manjrekar, Kamesh Maske, Arati Sanjay Bhelekar, Kavita Nawale, Sadhana Kannan, Vikram Gota, Atanu Bhattacharjee, Shubhada Kane, Shashikant L Juvekar, Kumar Prabhash
Purpose Chemoradiation with cisplatin 100 mg/m2 given once every 3 weeks is the standard of care in locally advanced head and neck squamous cell cancer (LAHNSCC). Increasingly, low-dose once-a-week cisplatin is substituted because of perceived lower toxicity and convenience. However, there is no level 1 evidence of comparable efficacy to cisplatin once every 3 weeks. Patients and Methods In this phase III randomized trial, we assessed the noninferiority of cisplatin 30 mg/m2 given once a week compared with cisplatin 100 mg/m2 given once every 3 weeks, both administered concurrently with curative intent radiotherapy in patients with LAHNSCC...
December 8, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29219612/nonprogression-with-avelumab-treatment-associated-with-gains-in-quality-of-life-in-metastatic-merkel-cell-carcinoma
#11
Howard L Kaufman, Matthias Hunger, Meliessa Hennessy, Michael Schlichting, Murtuza Bharmal
AIM: To assess the association between tumor response and health-related quality of life (HRQoL) in patients with metastatic Merkel cell carcinoma treated with the anti-PD-L1 avelumab. MATERIALS & METHODS: Phase II single-arm trial (NCT02155647) data of 88 patients were analyzed. Correlations between percentage reduction in tumor size and change from baseline in Functional Assessment of Cancer Therapy - General (FACT-G), FACT - Melanoma (FACT-M) and EuroQol-5 Dimension scores were calculated...
December 8, 2017: Future Oncology
https://www.readbyqxmd.com/read/29219016/pembrolizumab-in-the-treatment-of-advanced-urothelial-cancer
#12
Kevin T Lundgren, Matthew S Farina, Joaquim Bellmunt
Pembrolizumab is a humanized monoclonal antibody that targets PD-1. In the Phase III trial KEYNOTE-045, pembrolizumab was associated with a significant overall survival benefit when compared with docetaxel, paclitaxel and vinflunine in second line metastatic urothelial carcinoma (UC). Additionally, in the first line, early results from an interim analysis of the Phase II trial Keynote-052 study indicated that pembrolizumab is efficacious for cisplatin-ineligible patients. Based on data from these trials, pembrolizumab was the most recent among the five checkpoint inhibitors tested in UC to be approved by the US FDA in May 2017...
December 2017: Future Oncology
https://www.readbyqxmd.com/read/29218366/haploidentical-natural-killer-cells-induce-remissions-in-non-hodgkin-lymphoma-patients-with-low-levels-of-immune-suppressor-cells
#13
Veronika Bachanova, Dhifaf Sarhan, Todd E DeFor, Sarah Cooley, Angela Panoskaltsis-Mortari, Bruce R Blazar, Julie M Curtsinger, Linda Burns, Daniel J Weisdorf, Jeffrey S Miller
We report a novel phase 2 clinical trial in patients with poor prognosis refractory non-Hodgkin lymphoma (NHL) testing the efficacy of haploidentical donor natural killer (NK) cell therapy (NK dose 0.5-3.27 × 107 NK cells/kg) with rituximab and IL-2 (clinicaltrials.gov NCT01181258). Therapy was tolerated without graft-versus-host disease, cytokine release syndrome, or neurotoxicity. Of 14 evaluable patients, 4 had objective responses (29%; 95% CI 12-55%) at 2 months: 2 had complete response lasting 3 and 9 months...
December 7, 2017: Cancer Immunology, Immunotherapy: CII
https://www.readbyqxmd.com/read/29218326/study-protocol-a-multi-centre-double-blind-randomised-placebo-controlled-parallel-group-phase-ii-trial-ridd-to-determine-the-efficacy-of-intra-nodular-injection-of-anti-tnf-to-control-disease-progression-in-early-dupuytren-s-disease-with-an-embedded-dose-response
#14
Jagdeep Nanchahal, Catherine Ball, Jennifer Swettenham, Susan Dutton, Vicki Barber, Joanna Black, Bethan Copsey, Melina Dritsaki, Peter Taylor, Alastair Gray, Marc Feldmann, Sarah Lamb
Dupuytren's disease is a common fibrotic condition of the hand affecting 4% of the population and causes the fingers to curl irreversibly into the palm. It has a strong familial tendency, there is no approved treatment for early stage disease, and patients with established digital contractures are most commonly treated by surgery. This is associated with prolonged recovery, and less invasive techniques have high recurrence rates.The myofibroblasts, the cells responsible for the excessive matrix deposition and contraction, are aggregated in nodules...
2017: Wellcome Open Research
https://www.readbyqxmd.com/read/29218117/basis-and-statistical-design-of-the-passive-hiv-1-antibody-mediated-prevention-amp-test-of-concept-efficacy-trials
#15
Peter B Gilbert, Michal Juraska, Allan C deCamp, Shelly Karuna, Srilatha Edupuganti, Nyaradzo Mgodi, Deborah J Donnell, Carter Bentley, Nirupama Sista, Philip Andrew, Abby Isaacs, Yunda Huang, Lily Zhang, Edmund Capparelli, Nidhi Kochar, Jing Wang, Susan H Eshleman, Kenneth H Mayer, Craig A Magaret, John Hural, James G Kublin, Glenda Gray, David C Montefiori, Margarita M Gomez, David N Burns, Julie McElrath, Julie Ledgerwood, Barney S Graham, John R Mascola, Myron Cohen, Lawrence Corey
Background: Anti-HIV-1 broadly neutralizing antibodies (bnAbs) have been developed as potential agents for prevention of HIV-1 infection. The HIV Vaccine Trials Network and the HIV Prevention Trials Network are conducting the Antibody Mediated Prevention (AMP) trials to assess whether, and how, intravenous infusion of the anti-CD4 binding site bnAb, VRC01, prevents HIV-1 infection. These are the first test-of-concept studies to assess HIV-1 bnAb prevention efficacy in humans. Methods: The AMP trials are two parallel phase 2b HIV-1 prevention efficacy trials conducted in two cohorts: 2700 HIV-uninfected men and transgender persons who have sex with men in the United States, Peru, Brazil, and Switzerland; and 1500 HIV-uninfected sexually active women in seven countries in sub-Saharan Africa...
January 2017: Statistical Communications in Infectious Diseases
https://www.readbyqxmd.com/read/29217387/individualised-versus-standard-duration-of-elastic-compression-therapy-for-prevention-of-post-thrombotic-syndrome-ideal-dvt-a-multicentre-randomised-single-blind-allocation-concealed-non-inferiority-trial
#16
Arina J Ten Cate-Hoek, Elham E Amin, Annemieke C Bouman, Karina Meijer, Lidwine W Tick, Saskia Middeldorp, Guy J M Mostard, Marije Ten Wolde, Simone M van den Heiligenberg, Sanne van Wissen, Marlène Hw van de Poel, Sabina Villalta, Erik H Serné, Hans-Martin Otten, Edith H Klappe, Ingrid M Bistervels, Mandy N Lauw, Margriet Piersma-Wichers, Paolo Prandoni, Manuela A Joore, Martin H Prins, Hugo Ten Cate
BACKGROUND: Therapy with elastic compression stockings has been the cornerstone for prevention of post-thrombotic syndrome for decades in patients after acute deep venous thrombosis. It is uncertain who benefits most from therapy, and what the optimum duration of therapy should be. We therefore aimed to assess the safety and efficacy of individualised duration of compression therapy versus the standard duration of 24 months following an initial treatment period of 6 months. METHODS: We did a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial at 12 hospitals in the Netherlands and two in Italy...
December 4, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/29217376/safety-tolerability-and-immunogenicity-of-two-zika-virus-dna-vaccine-candidates-in-healthy-adults-randomised-open-label-phase-1-clinical-trials
#17
Martin R Gaudinski, Katherine V Houser, Kaitlyn M Morabito, Zonghui Hu, Galina Yamshchikov, Ro Shauna Rothwell, Nina Berkowitz, Floreliz Mendoza, Jamie G Saunders, Laura Novik, Cynthia S Hendel, LaSonji A Holman, Ingelise J Gordon, Josephine H Cox, Srilatha Edupuganti, Monica A McArthur, Nadine G Rouphael, Kirsten E Lyke, Ginny E Cummings, Sandra Sitar, Robert T Bailer, Bryant M Foreman, Katherine Burgomaster, Rebecca S Pelc, David N Gordon, Christina R DeMaso, Kimberly A Dowd, Carolyn Laurencot, Richard M Schwartz, John R Mascola, Barney S Graham, Theodore C Pierson, Julie E Ledgerwood, Grace L Chen
BACKGROUND: The Zika virus epidemic and associated congenital infections have prompted rapid vaccine development. We assessed two new DNA vaccines expressing premembrane and envelope Zika virus structural proteins. METHODS: We did two phase 1, randomised, open-label trials involving healthy adult volunteers. The VRC 319 trial, done in three centres, assessed plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera), and the VRC 320, done in one centre, assessed plasmid VRC5283 (wild-type Zika virus)...
December 4, 2017: Lancet
https://www.readbyqxmd.com/read/29217375/preliminary-aggregate-safety-and-immunogenicity-results-from-three-trials-of-a-purified-inactivated-zika-virus-vaccine-candidate-phase-1-randomised-double-blind-placebo-controlled-clinical-trials
#18
Kayvon Modjarrad, Leyi Lin, Sarah L George, Kathryn E Stephenson, Kenneth H Eckels, Rafael A De La Barrera, Richard G Jarman, Erica Sondergaard, Janice Tennant, Jessica L Ansel, Kristin Mills, Michael Koren, Merlin L Robb, Jill Barrett, Jason Thompson, Alison E Kosel, Peter Dawson, Andrew Hale, C Sabrina Tan, Stephen R Walsh, Keith E Meyer, James Brien, Trevor A Crowell, Azra Blazevic, Karla Mosby, Rafael A Larocca, Peter Abbink, Michael Boyd, Christine A Bricault, Michael S Seaman, Anne Basil, Melissa Walsh, Veronica Tonwe, Daniel F Hoft, Stephen J Thomas, Dan H Barouch, Nelson L Michael
BACKGROUND: A safe, effective, and rapidly scalable vaccine against Zika virus infection is needed. We developed a purified formalin-inactivated Zika virus vaccine (ZPIV) candidate that showed protection in mice and non-human primates against viraemia after Zika virus challenge. Here we present the preliminary results in human beings. METHODS: We did three phase 1, placebo-controlled, double-blind trials of ZPIV with aluminium hydroxide adjuvant. In all three studies, healthy adults were randomly assigned by a computer-generated list to receive 5 μg ZPIV or saline placebo, in a ratio of 4:1 at Walter Reed Army Institute of Research, Silver Spring, MD, USA, or of 5:1 at Saint Louis University, Saint Louis, MO, USA, and Beth Israel Deaconess Medical Center, Boston, MA, USA...
December 4, 2017: Lancet
https://www.readbyqxmd.com/read/29217288/avelumab-in-metastatic-urothelial-carcinoma-after-platinum-failure-javelin-solid-tumor-pooled-results-from-two-expansion-cohorts-of-an-open-label-phase-1-trial
#19
Manish R Patel, John Ellerton, Jeffrey R Infante, Manish Agrawal, Michael Gordon, Raid Aljumaily, Carolyn D Britten, Luc Dirix, Keun-Wook Lee, Mathew Taylor, Patrick Schöffski, Ding Wang, Alain Ravaud, Arnold B Gelb, Junyuan Xiong, Galit Rosen, James L Gulley, Andrea B Apolo
BACKGROUND: The approval of anti-programmed death ligand 1 (PD-L1) and anti-programmed death 1 agents has expanded treatment options for patients with locally advanced or metastatic urothelial carcinoma. Avelumab, a human monoclonal anti-PD-L1 antibody, has shown promising antitumour activity and safety in this disease. We aimed to assess the safety profile in patients (both post-platinum therapy and cisplatin-naive) treated with avelumab and to assess antitumour activity of this drug in post-platinum patients...
December 4, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29216787/mek-inhibitors-under-development-for-treatment-of-non-small-cell-lung-cancer
#20
Chul Kim, Giuseppe Giaccone
The mitogen-activated protein kinase (MAPK) pathway is intimately implicated in the molecular pathogenesis of non-small-cell lung cancer (NSCLC). Aberrant MAPK signaling resulting from the upstream activating mutations converges on mitogen-activated protein kinase kinase 1/2 (MEK1/2), making MEK inhibition an attractive strategy for the treatment of NSCLC. Several MEK inhibitors have demonstrated anticancer activity in patients with NSCLC. Areas covered: In this article, we discuss the biological rationale for the use of MEK inhibitors and summarize the clinical experience with MEK1/2 inhibitors for the treatment of NSCLC, from initial phase I studies to phase II/III studies, both as monotherapy or in combination with other anticancer agents...
December 7, 2017: Expert Opinion on Investigational Drugs
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