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Phase 3 oncology

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https://www.readbyqxmd.com/read/28822576/pembrolizumab-versus-ipilimumab-for-advanced-melanoma-final-overall-survival-results-of-a-multicentre-randomised-open-label-phase-3-study-keynote-006
#1
Jacob Schachter, Antoni Ribas, Georgina V Long, Ana Arance, Jean-Jacques Grob, Laurent Mortier, Adil Daud, Matteo S Carlino, Catriona McNeil, Michal Lotem, James Larkin, Paul Lorigan, Bart Neyns, Christian Blank, Teresa M Petrella, Omid Hamid, Honghong Zhou, Scot Ebbinghaus, Nageatte Ibrahim, Caroline Robert
BACKGROUND: Interim analyses of the phase 3 KEYNOTE-006 study showed superior overall and progression-free survival of pembrolizumab versus ipilimumab in patients with advanced melanoma. We present the final protocol-specified survival analysis. METHODS: In this multicentre, open-label, randomised, phase 3 trial, we recruited patients from 87 academic institutions, hospitals, and cancer centres in 16 countries (Australia, Austria, Belgium, Canada, Chile, Colombia, France, Germany, Israel, Netherlands, New Zealand, Norway, Spain, Sweden, UK, and USA)...
August 16, 2017: Lancet
https://www.readbyqxmd.com/read/28817175/drug-development-for-breast-colorectal-and-non-small-cell-lung-cancers-from-1979-to-2014
#2
Nancy A Nixon, Omar F Khan, Hasiba Imam, Patricia A Tang, Jose Monzon, Haocheng Li, Gavin Sun, Doreen Ezeife, Sunil Parimi, Scot Dowden, Vincent C Tam
BACKGROUND: Understanding the drug development pathway is critical for streamlining the development of effective cancer treatments. The objective of the current study was to delineate the drug development timeline and attrition rate of different drug classes for common cancer disease sites. METHODS: Drugs entering clinical trials for breast, colorectal, and non-small cell lung cancer were identified using a pharmaceutical business intelligence database. Data regarding drug characteristics, clinical trials, and approval dates were obtained from the database, clinical trial registries, PubMed, and regulatory Web sites...
August 17, 2017: Cancer
https://www.readbyqxmd.com/read/28814378/mhealth-technologies-for-palliative-care-patients-at-the-interface-of-in-patient-to-outpatient-care-protocol-of-feasibility-study-aiming-to-early-predict-deterioration-of-patient-s-health-status
#3
Gudrun Theile, Vanessa Klaas, Gerhard Tröster, Matthias Guckenberger
BACKGROUND: Palliative care patients are a particularly vulnerable population and one of the critical phases in patients' trajectories is discharge from specialized in-patient palliative care into outpatient care, where availability of a palliative care infrastructure is highly variable. A relevant number of potentially avoidable readmissions and emergency visits of palliative patients is observed due to rapid exacerbation of symptoms indicating the need for a closer patient monitoring...
August 16, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28809610/phase-iii-study-comparing-a-reduced-dose-of-cabazitaxel-20-mg-m-2-and-the-currently-approved-dose-25-mg-m-2-in-postdocetaxel-patients-with-metastatic-castration-resistant-prostate-cancer-proselica
#4
Mario Eisenberger, Anne-Claire Hardy-Bessard, Choung Soo Kim, Lajos Géczi, Daniel Ford, Loïc Mourey, Joan Carles, Phillip Parente, Albert Font, Gabriel Kacso, Mustapha Chadjaa, Wenping Zhang, John Bernard, Johann de Bono
Purpose Cabazitaxel 25 mg/m(2) (C25) significantly improved overall survival (OS) versus mitoxantrone ( P < .001) in postdocetaxel patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase III TROPIC study. The phase III PROSELICA study ( ClinicalTrials.gov identifier: NCT01308580) assessed the noninferiority of cabazitaxel 20 mg/m(2) (C20) versus C25 in postdocetaxel patients with mCRPC. Methods Patients were stratified by Eastern Cooperative Oncology Group performance status, measurability of disease per Response Evaluation Criteria in Solid Tumors (RECIST), and region, and randomly assigned to receive C20 or C25...
August 15, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28802766/a-phase-i-trial-of-intraperitoneal-gen-1-an-il-12-plasmid-formulated-with-peg-pei-cholesterol-lipopolymer-administered-with-pegylated-liposomal-doxorubicin-in-patients-with-recurrent-or-persistent-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-cancers
#5
REVIEW
Premal H Thaker, William E Brady, Heather A Lankes, Kunle Odunsi, William H Bradley, Kathleen N Moore, Carolyn Y Muller, Khursheed Anwer, Russell J Schilder, Ronald D Alvarez, Paula M Fracasso
OBJECTIVE: The study's purpose was to assess safety and efficacy of escalating doses of weekly GEN-1 with pegylated liposomal doxorubicin (PLD) in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancers (EOC). METHODS: Patients had persistent or recurrent platinum-resistant EOC. The trial was a standard 3+3 phase I dose escalation design with patients receiving intravenous PLD 40mg/m(2) (dose level 1 and 2) or 50mg/m(2) (dose level 3) every 28days and intraperitoneal GEN-1 at 24mg/m(2) (dose level 1) or 36mg/m(2) (dose level 2 and 3) on days 1, 8, 15, and 22 of a 28day cycle...
August 9, 2017: Gynecologic Oncology
https://www.readbyqxmd.com/read/28799187/safety-evaluation-of-combination-carboplatin-and-toceranib-phosphate-palladia-in-tumour-bearing-dogs-a-phase-i-dose-finding-study
#6
R M Wouda, S E Hocker, M L Higginbotham
Combining conventional cytotoxic maximum tolerated dose (MTD) chemotherapy with low-dose metronomic and/or anti-angiogenic agents is a exciting area of oncologic research. The objective of this study was to establish the MTD, safety and adverse event (AE) profile of 1 such drug combination. This prospective phase I dose-finding clinical trial assumed an open-label 3 + 3 cohort design. Client-owned dogs with 1 or more cytologically and/or histologically confirmed and macroscopically measurable, naive or recurrent, malignant tumours, were enrolled...
August 10, 2017: Veterinary and Comparative Oncology
https://www.readbyqxmd.com/read/28796729/postoperative-chemoradiotherapy-after-local-resection-for-high-risk-t1-to-t2-low-rectal-cancer-results-of-a-single-arm-multi-institutional-phase-ii-clinical-trial
#7
Takeshi Sasaki, Yoshinori Ito, Masayuki Ohue, Yukihide Kanemitsu, Takaya Kobatake, Masaaki Ito, Yoshihiro Moriya, Norio Saito
BACKGROUND: After treatment with local excision for TNM stage I low rectal cancer, the risk of local recurrence is not only high for T2 lesions but also for T1 lesions with features of massive invasion to the submucosal layer and/or lymphovascular invasion. OBJECTIVE: The purpose of this study was to determine the efficacy of chemoradiotherapy combined with local excision in the treatment of T1 to T2 low rectal cancer. DESIGN: We conducted a prospective, single-arm, phase II trial...
September 2017: Diseases of the Colon and Rectum
https://www.readbyqxmd.com/read/28780466/carboplatin-versus-two-doses-of-cisplatin-in-combination-with-gemcitabine-in-the-treatment-of-advanced-non-small-cell-lung-cancer-results-from-a-british-thoracic-oncology-group-randomised-phase-iii-trial
#8
David Ferry, Lucinda Billingham, Hugh Jarrett, David Dunlop, Penella J Woll, Marianne Nicolson, Riyaz Shah, Joyce Thompson, James Spicer, D Muthukumar, Geraldine Skailes, Pauline Leonard, A D Chetiyawardana, Paula Wells, Conrad Lewanski, Barbara Crosse, Michelle Hill, Piers Gaunt, Kenneth O'Byrne
BACKGROUND: Platinum-based combination chemotherapy is standard treatment for the majority of patients with advanced non-small-cell lung cancer (NSCLC). The trial investigates the importance of the choice of platinum agent and dose of cisplatin in relation to patient outcomes. METHODS: The three-arm randomised phase III trial assigned patients with chemo-naïve stage IIIB/IV NSCLC in a 1:1:1 ratio to receive gemcitabine 1250 mg/m(2) on days 1 and 8 of a 3-week cycle with cisplatin 80 mg/m(2) (GC80) or cisplatin 50 mg/m(2) (GC50) or carboplatin AUC6 (GCb6) for a maximum of four cycles...
August 3, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28777677/my-kite-will-fly-improving-communication-and-understanding-in-young-children-when-a-mother-is-diagnosed-with-life-threatening-gynecological-cancer
#9
Cynthia Holland, Alison Hocking, Lynette Joubert, Fiona McDermott, Marcus D Niski, Frances Thomson Salo, Michael A Quinn
STUDY AIMS: The My Kite Will Fly (MKWF) research program is built on the well-documented need for effective clinical communication tools and therapeutic interventions where a child's mother is diagnosed with life-threatening gynecological cancer. METHODS: The Dignity Model and Child-Centered approach were two key study foundations in this pilot cohort. Quantitative survey and qualitative semistructured methods were employed to gather data from patient families at three distinct phases: Diagnosis, Treatment, and Palliative care...
August 4, 2017: Journal of Palliative Medicine
https://www.readbyqxmd.com/read/28774463/clinical-trials-a-pending-subject
#10
B Gil-Extremera, P Jiménez-López, J D Mediavilla-García
Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige...
July 31, 2017: Revista Clínica Española
https://www.readbyqxmd.com/read/28767288/arsenic-trioxide-consolidation-allows-anthracycline-dose-reduction-for-pediatric-patients-with-acute-promyelocytic-leukemia-report-from-the-children-s-oncology-group-phase-iii-historically-controlled-trial-aaml0631
#11
Matthew A Kutny, Todd A Alonzo, Robert B Gerbing, Yi-Cheng Wang, Susana C Raimondi, Betsy A Hirsch, Cecilia H Fu, Soheil Meshinchi, Alan S Gamis, James H Feusner, John J Gregory
Purpose The Children's Oncology Group AAML0631 trial for newly diagnosed pediatric acute promyelocytic leukemia (APL) was a phase III historically controlled trial to determine the survival of patients receiving arsenic trioxide (ATO) consolidation and reduced doses of anthracyclines. Patients and Methods Patients age 2 to 21 years with de novo APL confirmed by PML-RARα polymerase chain reaction were stratified as standard risk (SR) or high risk (HR) on the basis of diagnostic WBC count. All patients received all-trans retinoic acid (ATRA) during induction, each consolidation course, and maintenance...
August 2, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28761384/new-pd-l1-inhibitors-in-non-small-cell-lung-cancer-impact-of-atezolizumab
#12
REVIEW
Nagashree Seetharamu, Isabel R Preeshagul, Kevin M Sullivan
The era of immunotherapy has changed the face of how we approach treatment for many oncologic and hematologic malignancies. Lung cancer has been in the forefront of checkpoint inhibition for the past 2 years and has paved the path for other subspecialties. While PD-1 inhibitors nivolumab and pembrolizumab have been approved for non-small cell lung cancer (NSCLC), this review focuses on atezolizumab, its landmark studies, and ongoing trials. Atezolizumab is the first programmed death ligand 1 (PD-L1) inhibitor to receive US Food and Drug Administration (FDA) approval for metastatic NSCLC patients who have progressed on frontline chemotherapy...
2017: Lung Cancer: Targets and Therapy
https://www.readbyqxmd.com/read/28760399/tas-102-plus-bevacizumab-for-patients-with-metastatic-colorectal-cancer-refractory-to-standard-therapies-c-task-force-an-investigator-initiated-open-label-single-arm-multicentre-phase-1-2-study
#13
Yasutoshi Kuboki, Tomohiro Nishina, Eiji Shinozaki, Kentaro Yamazaki, Kohei Shitara, Wataru Okamoto, Takeshi Kajiwara, Toshihiko Matsumoto, Takahiro Tsushima, Nobuo Mochizuki, Shogo Nomura, Toshihiko Doi, Akihiro Sato, Atsushi Ohtsu, Takayuki Yoshino
BACKGROUND: In patients with heavily treated metastatic colorectal cancer, TAS-102-a combination of trifluridine and tipiracil-has shown a significant overall survival benefit compared with placebo. In preclinical models, TAS-102 plus bevacizumab has shown enhanced activity against colorectal cancer xenografts compared with that for either drug alone. In this phase 1/2 study, we assessed the activity and safety of TAS-102 plus bevacizumab. METHODS: We did this investigator-initiated, open-label, single-arm, multicentre, phase 1/2 trial of TAS-102 plus bevacizumab in four cancer centres in Japan...
July 28, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28756902/bevacizumab-for-advanced-cervical-cancer-final-overall-survival-and-adverse-event-analysis-of-a-randomised-controlled-open-label-phase-3-trial-gynecologic-oncology-group-240
#14
Krishnansu S Tewari, Michael W Sill, Richard T Penson, Helen Huang, Lois M Ramondetta, Lisa M Landrum, Ana Oaknin, Thomas J Reid, Mario M Leitao, Helen E Michael, Philip J DiSaia, Larry J Copeland, William T Creasman, Frederick B Stehman, Mark F Brady, Robert A Burger, J Tate Thigpen, Michael J Birrer, Steven E Waggoner, David H Moore, Katherine Y Look, Wui-Jin Koh, Bradley J Monk
BACKGROUND: On Aug 14, 2014, the US Food and Drug Administration approved the antiangiogenesis drug bevacizumab for women with advanced cervical cancer on the basis of improved overall survival (OS) after the second interim analysis (in 2012) of 271 deaths in the Gynecologic Oncology Group (GOG) 240 trial. In this study, we report the prespecified final analysis of the primary objectives, OS and adverse events. METHODS: In this randomised, controlled, open-label, phase 3 trial, we recruited patients with metastatic, persistent, or recurrent cervical carcinoma from 81 centres in the USA, Canada, and Spain...
July 27, 2017: Lancet
https://www.readbyqxmd.com/read/28756871/randomized-phase-iib-evaluation-of-weekly-paclitaxel-versus-weekly-paclitaxel-with-oncolytic-reovirus-reolysin%C3%A2-in-recurrent-ovarian-tubal-or-peritoneal-cancer-an-nrg-oncology-gynecologic-oncology-group-study
#15
REVIEW
David E Cohn, Michael W Sill, Joan L Walker, David O'Malley, Christa I Nagel, Teresa L Rutledge, William Bradley, Debra L Richardson, Katherine M Moxley, Carol Aghajanian
OBJECTIVE: To assess whether the addition of oncolytic reovirus (Reolysin®) to weekly paclitaxel prolonged progression-free survival (PFS) in the treatment of women with recurrent or persistent ovarian, tubal or primary peritoneal cancer. PATIENTS AND METHODS: Patients with recurrent or persistent epithelial ovarian, tubal, or peritoneal carcinoma, measurable or detectable disease, and three or fewer prior regimens were randomly assigned to paclitaxel (80mg/m(2) intravenously days 1, 8, and 15 every 4weeks) or the combination of paclitaxel (80mg/m(2) intravenously days 1, 8, and 15) plus reovirus 3×10(10)TCID50/day intravenously on days 1-5, both every 4weeks until disease progression or toxicity...
July 27, 2017: Gynecologic Oncology
https://www.readbyqxmd.com/read/28754483/olaparib-tablets-as-maintenance-therapy-in-patients-with-platinum-sensitive-relapsed-ovarian-cancer-and-a-brca1-2-mutation-solo2-engot-ov21-a-double-blind-randomised-placebo-controlled-phase-3-trial
#16
Eric Pujade-Lauraine, Jonathan A Ledermann, Frédéric Selle, Val Gebski, Richard T Penson, Amit M Oza, Jacob Korach, Tomasz Huzarski, Andrés Poveda, Sandro Pignata, Michael Friedlander, Nicoletta Colombo, Philipp Harter, Keiichi Fujiwara, Isabelle Ray-Coquard, Susana Banerjee, Joyce Liu, Elizabeth S Lowe, Ralph Bloomfield, Patricia Pautier
BACKGROUND: Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib. METHODS: This international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy...
July 25, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28753384/cabazitaxel-versus-docetaxel-as-first-line-therapy-for-patients-with-metastatic-castration-resistant-prostate-cancer-a-randomized-phase-iii-trial-firstana
#17
Stéphane Oudard, Karim Fizazi, Lisa Sengeløv, Gedske Daugaard, Fred Saad, Steinbjørn Hansen, Marie Hjälm-Eriksson, Jacek Jassem, Antoine Thiery-Vuillemin, Orazio Caffo, Daniel Castellano, Paul N Mainwaring, John Bernard, Liji Shen, Mustapha Chadjaa, Oliver Sartor
Purpose In patients with metastatic castration-resistant prostate cancer (mCRPC), overall survival (OS) is significantly improved with cabazitaxel versus mitoxantrone after prior docetaxel treatment. FIRSTANA ( ClinicalTrials.gov identifier: NCT01308567) assessed whether cabazitaxel 20 mg/m(2) (C20) or 25 mg/m(2) (C25) is superior to docetaxel 75 mg/m(2) (D75) in terms of OS in patients with chemotherapy-naïve mCRPC. Patients and Methods Patients with mCRPC and Eastern Cooperative Oncology Group performance status of 0 to 2 were randomly assigned 1:1:1 to receive C20, C25, or D75 intravenously every 3 weeks plus daily prednisone...
July 28, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28751444/pediatric-phase-1-trial-and-pharmacokinetic-study-of-trebananib-in-relapsed-solid-tumors-advl1115-a-children-s-oncology-group-phase-1-consortium-report
#18
Sarah E S Leary, Julie R Park, Joel M Reid, Andrew T Ralya, Sylvain Baruchel, Bing Wu, Timothy P L Roberts, Xiaowei Liu, Charles G Minard, Elizabeth Fox, Brenda J Weigel, Susan Blaney
Trebananib is a first-in-class anti-angiogenic peptibody (peptide-Fc fusion protein) that inhibits Angiopoietin 1 and 2. A pediatric phase 1 trial was performed to define trebananib dose limiting toxicities (DLT), recommended phase 2 dose (RP2D) and pharmacokinetics (PK).<br /><br />Experimental Design: Trebananib was administered by weekly infusion. Three dose levels (10, 15 or 30 mg/kg/dose) were evaluated using a rolling-six design. Part 2 evaluated a cohort of subjects with primary central nervous system (CNS) tumors...
July 27, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28744724/concordance-of-clinical-diagnosis-of-t-classification-among-physicians-for-locally-advanced-unresectable-thoracic-esophageal-cancer
#19
Tomoya Yokota, Takushi Yasuda, Hiroyuki Kato, Isao Nozaki, Hiroshi Sato, Yoshinori Miyata, Yoshifumi Kuroki, Ken Kato, Yasuo Hamamoto, Yasuhiro Tsubosa, Hirofumi Ogawa, Yoshinori Ito, Yuko Kitagawa
BACKGROUND: We conducted a multicenter phase II trial assessing chemoselection with docetaxel plus 5-fluorouracil and cisplatin induction chemotherapy and subsequent conversion surgery for locally advanced, unresectable esophageal cancer. The aim of this study was to validate the concordance of clinical T diagnosis among physicians in the cases of this trial. METHODS: Computed tomography scans and esophagoscopic images of 48 patients taken at baseline were centrally reviewed by 6 senior physicians with experience in esophageal oncology...
July 25, 2017: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28741175/a-randomized-phase-ii-trial-of-geriatric-assessment-and-management-for-older-cancer-patients
#20
Martine T E Puts, Schroder Sattar, Michael Kulik, Mary Ellen MacDonald, Kara McWatters, Katherine Lee, Sarah Brennenstuhl, Raymond Jang, Eitan Amir, Monika K Krzyzanowska, Anthony M Joshua, Johanne Monette, Doreen Wan-Chow-Wah, Shabbir M H Alibhai
PURPOSE: Geriatric assessment and management (GAM) can identify current health issues and recommend interventions to optimize well-being of older adults, but no randomized trial has yet been completed in oncology. Therefore, a randomized phase 2 trial was conducted. METHODS: A two-group parallel single-blinded randomized phase II trial ( ClinicalTrials.gov Identifier: NCT02222259) enrolled patients aged ≥70 years, diagnosed with stage 2-4 gastrointestinal, genitourinary, or breast cancer within 6 weeks of commencing chemotherapy at Princess Margaret Cancer Centre...
July 25, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
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