keyword
MENU ▼
Read by QxMD icon Read
search

Phase I trials

keyword
https://www.readbyqxmd.com/read/29352572/phase-i-combination-study-of-the-parp-inhibitor-veliparib-plus-carboplatin-and-gemcitabine-in-patients-with-advanced-ovarian-cancer-and-other-solid-malignancies
#1
Heidi J Gray, Katherine Bell-McGuinn, Gini F Fleming, Mihaela Cristea, Hao Xiong, Danielle Sullivan, Yan Luo, Mark D McKee, Wijith Munasinghe, Lainie P Martin
OBJECTIVE: Determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of veliparib combined with carboplatin and gemcitabine in patients with advanced ovarian cancer and other nonhematologic malignancies. METHODS: In this phase I study, patients with metastatic or unresectable solid tumors and ≤2 prior chemotherapy regimens received veliparib combined with carboplatin area under the curve (AUC) 4 on day 1 and gemcitabine 800mg/m2 on days 1 and 8 of a 21-day cycle for maximum 10cycles, followed by optional veliparib maintenance therapy...
January 15, 2018: Gynecologic Oncology
https://www.readbyqxmd.com/read/29352347/autologous-cell-based-therapy-for-treatment-of-large-bone-defects-from-bench-to-bedside
#2
REVIEW
R Verboket, M Leiblein, C Seebach, C Nau, M Janko, M Bellen, H Bönig, D Henrich, I Marzi
OBJECTIVES: Reconstruction of long segmental bone defects is demanding for patients and surgeons, and associated with long-term treatment periods and substantial complication rates in addition to high costs. While defects up to 4-5 cm length might be filled up with autologous bone graft, heterologous bone from cadavers, or artificial bone graft substitutes, current options to reconstruct bone defects greater than 5 cm consist of either vascularized free bone transfers, the Masquelet technique or the Ilizarov distraction osteogenesis...
January 19, 2018: European Journal of Trauma and Emergency Surgery: Official Publication of the European Trauma Society
https://www.readbyqxmd.com/read/29351570/joint-adolescent-adult-early-phase-clinical-trials-to-improve-access-to-new-drugs-for-adolescents-with-cancer-proposals-from-the-multi-stakeholder-platform-accelerate
#3
N Gaspar, L V Marshall, D Binner, R Herold, R Rousseau, P Blanc, R Capdeville, J Carleer, C Copland, Y Kerloeguen, K Norga, L Pacaud, M-A Sevaux, C Spadoni, J Sterba, F Ligas, T Taube, M Uttenreuther-Fischer, S Chioato, M A O'Connell, B Geoerger, J-Y Blay, J C Soria, S Kaye, B Wulff, L Brugières, G Vassal, A D J Pearson
The impressive progress recently observed in adult cancers through the introduction of new drugs has not yet been translated to adolescents between 12 and 17 years of age. Currently adolescents are grouped with children, so their access to new, effective drugs already available for adults is delayed because paediatric drug development starts late relative to adult programmes. Moreover, specific early phase trials designed exclusively for adolescents in rare diseases recruit poorly, even if conducted internationally...
January 16, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29351125/central-inhibition-of-granulocyte-macrophage-colony-stimulating-factor-is-analgesic-in-experimental-neuropathic-pain
#4
Louise S C Nicol, Peter Thornton, Jon P Hatcher, Colin P Glover, Carl I Webster, Matthew Burrell, Kessia Hammett, Clare A Jones, Matthew A Sleeman, Andrew Billinton, Iain Chessell
With less than 50% of patients responding to the current standard of care and poor efficacy and selectivity of current treatments, neuropathic pain continues to be an area of considerable unmet medical need. Biological therapeutics such as monoclonal antibodies (mAbs) provide better intrinsic selectivity; however, delivery to the central nervous system (CNS) remains a challenge. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is well described in inflammation-induced pain, and early-phase clinical trials evaluating its antagonism have exemplified its importance as a peripheral pain target...
January 16, 2018: Pain
https://www.readbyqxmd.com/read/29350568/abp-980-promising-trastuzumab-biosimilar-for-her2-positive-breast-cancer
#5
Elisavet Paplomata, Rita Nahta
Approval of the HER2-targeted antibody trastuzumab dramatically improved outcomes for patients with HER2-positive breast cancer. Multiple trastuzumab biosimilars, including ABP 980, are in clinical development. Biosimilars are not identical to the reference biologic, but exhibit equivalence and safety in analytical and clinical studies. Areas covered: A brief introduction to trastuzumab, overview of trastuzumab biosimilars, and detailed review of ABP 980 preclinical and clinical studies are included. We searched PubMed and 2016-2017 ASCO and ESMO conference proceedings for "ABP 980" or "trastuzumab biosimilar"...
January 19, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29350463/brim-p-a-phase-i-open-label-multicenter-dose-escalation-study-of-vemurafenib-in-pediatric-patients-with-surgically-incurable-braf-mutation-positive-melanoma
#6
Julia C Chisholm, Jozef Suvada, Ira J Dunkel, Michela Casanova, Weijiang Zhang, Natasha Ritchie, YounJeong Choi, Jane Park, Meghna Das Thakur, Stephen Simko, Nga Wan Rachel Tam, Andrea Ferrari
BACKGROUND: Vemurafenib, a selective inhibitor of BRAF kinase, is approved for the treatment of adult stage IIIc/IV BRAF V600 mutation-positive melanoma. We conducted a phase I, open-label, dose-escalation study in pediatric patients aged 12-17 years with this tumor type (NCT01519323). PROCEDURE: Patients received vemurafenib orally until disease progression. Dose escalation was conducted using a 3 + 3 design. Patients were monitored for dose-limiting toxicities (DLTs) during the first 28 days of treatment to determine the maximum tolerated dose (MTD)...
January 19, 2018: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/29350084/exploring-assistive-technology-use-to-support-cognition-in-college-students-with-histories-of-mild-traumatic-brain-injury
#7
Jessica Brown, Madeline Wollersheim
PURPOSE: College students with mild traumatic brain injury (mTBI) may experience chronic cognitive deficits necessitating use of external supports for daily task completion. The purpose of this study was to explore cognitive support system selection and use by students with histories of mTBI when completing novel prospective memory tasks. MATERIALS AND METHODS: We implemented a multiple case study, sequential explanatory mixed-methods design with three participants...
January 19, 2018: Disability and Rehabilitation. Assistive Technology
https://www.readbyqxmd.com/read/29346519/final-results-of-a-multi-institutional-phase-ii-trial-of-re-irradiation-with-concurrent-weekly-cisplatin-and-cetuximab-for-recurrent-or-second-primary-squamous-cell-carcinoma-of-the-head-and-neck
#8
M J Awan, L Nedzi, D Wang, V Tumati, B Sumer, X-J Xie, I Smith, J Truelson, R Hughes, L L Myers, P Lavertu, S Wong, M Yao
Background: The optimal regimen of chemotherapy and re-irradiation (re-XRT) for recurrent head and neck squamous cell carcinoma (HNSCC) is controversial. We report the final outcomes of a multi-center Phase II trial evaluating cetuximab and cisplatin-based chemotherapy concurrent with re-XRT for patients with recurrent HNSCC. Methods and Materials: Patients with unresectable recurrent disease or positive margins after salvage surgery arising within a previously irradiated field with KPS≥70 were eligible for this trial...
January 15, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29345044/preclinical-characterisation-of-absorption-distribution-metabolism-and-excretion-properties-of-tak-063
#9
Kimio Tohyama, Miyako Sudo, Akio Morohashi, Suguru Kato, Junzo Takahashi, Yoshihiko Tagawa
TAK-063 is currently being developed to treat schizophrenia. In this study, we investigated the absorption, distribution, metabolism and excretion (ADME) properties of TAK-063 using several paradigms. Following oral administration of TAK-063 at 0.3 mg/kg, bioavailability of TAK-063 was 27.4% in rats and 49.5% in dogs with elimination half-lives of 3.1 hr in rats and 3.7 hr in dogs. TAK-063 is a highly permeable compound without P-glycoprotein (P-gp) or breast cancer resistance protein substrate liability and can be readily absorbed into systemic circulation via the intestine...
January 17, 2018: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/29344270/lenvatinib-in-advanced-radioiodine-refractory-thyroid-cancer-a-retrospective-analysis-of-the-swiss-lenvatinib-named-patient-program
#10
Catharina Balmelli, Nikola Railic, Marco Siano, Kristin Feuerlein, Richard Cathomas, Valerie Cristina, Christiane Güthner, Stefan Zimmermann, Sabine Weidner, Miklos Pless, Frank Stenner, Sacha I Rothschild
Purpose: Differentiated thyroid cancer (DTC) accounts for approximately 95% of thyroid carcinomas. In the metastatic RAI-refractory disease, chemotherapy has very limited efficacy and is associated with substantial toxicity. With increasing knowledge of the molecular pathogenesis of DTC, novel targeted therapies have been developed. Lenvatinib is a tyrosine kinase inhibitor (TKI) with promising clinical activity based on the randomized phase III SELECT trial. In Switzerland, a Named Patient Program (NPP) was installed to bridge the time gap to Swissmedic approval...
2018: Journal of Cancer
https://www.readbyqxmd.com/read/29343882/can-productivity-and-profitability-be-enhanced-in-intensively-managed-cereal-systems-while-reducing-the-environmental-footprint-of-production-assessing-sustainable-intensification-options-in-the-breadbasket-of-india
#11
Virender Kumar, Hanuman S Jat, Parbodh C Sharma, Balwinder-Singh, Mahesh K Gathala, Ram K Malik, Baldev R Kamboj, Arvind K Yadav, Jagdish K Ladha, Anitha Raman, D K Sharma, Andrew McDonald
In the most productive area of the Indo-Gangetic Plains in Northwest India where high yields of rice and wheat are commonplace, a medium-term cropping system trial was conducted in Haryana State. The goal of the study was to identify integrated management options for further improving productivity and profitability while rationalizing resource use and reducing environmental externalities (i.e., "sustainable intensification", SI) by drawing on the principles of diversification, precision management, and conservation agriculture...
January 15, 2018: Agriculture, Ecosystems & Environment
https://www.readbyqxmd.com/read/29341179/better-characterization-of-vinflunine-pharmacokinetics-variability-and-exposure-toxicity-relationship-to-improve-its-use-analyses-from-18-trials
#12
A Schmitt, L Nguyen, G Zorza, P Ferré, A Pétain
AIMS: Vinflunine is a novel tubulin-targeted inhibitor indicated as a single agent for the treatment of bladder cancers after failure of prior platinum-based therapy. Its pharmacokinetics (PK) and pharmacodynamics (PD) have been independently characterized through several phase I and phase II studies. However, no global pharmacometric analysis had been conducted yet. METHODS: Vinflunine concentrations and safety data from 18 phase I and phase II studies were used to conduct population PK and PK/PD analysis, using Nonmem...
January 17, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29340601/how-to-treat-borderline-resectable-pancreatic-cancer-current-challenges-and-future-directions
#13
Shinichiro Takahashi
Borderline resectable pancreatic cancer (BRPC) is an advanced tumor in contact with the surrounding major vessels, making R0 resection difficult to achieve. Neoadjuvant treatment is expected to provide substantial local control and prolong survival. However, there is no standard treatment. I therefore conducted a strategic literature search from January 2013 to September 2017 and identified 37 clinical studies of pancreatic cancer, including BRPC, to evaluate treatment interventions. Twenty (54%) studies were prospective...
January 11, 2018: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29340092/first-line-dose-dense-chemotherapy-with-docetaxel-cisplatin-folinic-acid-and-5-fluorouracil-dcf-plus-panitumumab-in-patients-with-locally-advanced-or-metastatic-cancer-of-the-stomach-or-gastroesophageal-junction-final-results-and-biomarker-analysis-from-an
#14
Gianluca Tomasello, Nicola Valeri, Michele Ghidini, Elizabeth C Smyth, Wanda Liguigli, Laura Toppo, Rodolfo Mattioli, Alessandra Curti, Jens C Hahne, Federica M Negri, Stefano Panni, Margherita Ratti, Silvia Lazzarelli, Fabiana Gerevini, Chiara Colombi, Andrea Panni, Massimo Rovatti, Leonardo Treccani, Mario Martinotti, Rodolfo Passalacqua
Background: Survival for patients with advanced gastroesophageal cancer (AGC) using standard treatment regimens is poor. EGFR overexpression is common in AGC and associated with poor prognosis. We hypothesized that increasing the dose intensity of chemotherapy and adding panitumumab could improve efficacy. Methods: HER2 negative, PS 0-1 patients, received up to 4 cycles of panitumumab 6 mg/kg d 1, docetaxel 60 mg/m2 d 1, cisplatin 50 mg/m2 d 1, l-folinic acid 100 mg/m2 d 1-2, followed by 5-FU 400 mg/m2 bolus d 1-2, and then 600 mg/m2 as a 22 h c...
December 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/29340015/apatinib-alone-or-combined-with-radiotherapy-in-metastatic-prostate-cancer-results-from-a-pilot-multicenter-study
#15
Feng Zhao, Wei Tian, Ming Zeng, Jianling Xia, Honglin Hu, Xinbao Hao, Liangfu Han, Hao Liu, Yangke He, Xueqiang Zhu, Liang Liang, Rui Ao, Min Wei, Lili Deng, Yuquan Wei
Background: To study safety and efficacy of apatinib in combination of radiotherapy in patients with symptomatic bony disease prostate cancer(SBPC), based on the potential synergistic antitumor activity between apatinib and Radiation Therapy (RT). Patients and methods: In phase I dose escalation part, 18 patients received apatinib dose at 250 mg every other day, 250 mg daily and 500 mg daily. In phase II part, the 250 mg daily cohorts were expanded to 20 patients in combination of RT (6 Gy/fraction, 5 fraction in total), one patient lost followed up and excluded the study, comparing with RT alone cohort with 10 patients, ratio of RT to RT + apatinib was 1 to 2...
December 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/29336896/targeted-retinal-photocoagulation-for-diabetic-macular-edema-with-peripheral-retinal-nonperfusion-three-year-randomized-dave-trial
#16
David M Brown, William C Ou, Tien P Wong, Rosa Y Kim, Daniel E Croft, Charles C Wykoff
PURPOSE: To evaluate the effect of targeted retinal photocoagulation (TRP) on visual and anatomic outcomes and treatment burden in eyes with diabetic macular edema (DME). DESIGN: Phase I/II prospective, randomized, controlled clinical trial. PARTICIPANTS: Forty eyes of 29 patients with center-involved macular edema secondary to diabetes mellitus. METHODS: Eyes with center-involved DME and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 20/32 and 20/320 (Snellen equivalent) were randomized 1:1 to monotherapy with 0...
January 11, 2018: Ophthalmology
https://www.readbyqxmd.com/read/29336718/effect-of-irvingia-gabonensis-on-metabolic-syndrome-insulin-sensitivity-and-insulin-secretion
#17
Miriam Méndez-Del Villar, Manuel González-Ortiz, Esperanza Martínez-Abundis, Karina G Pérez-Rubio, Marisol Cortez-Navarrete
The aim of this study was to evaluate the effect of Irvingia gabonensis on metabolic syndrome (MetS), insulin sensitivity, and insulin secretion. A randomized, double-blind, placebo-controlled clinical trial was performed in 24 patients with MetS in accordance with the International Diabetes Federation criteria. Twelve patients received I. gabonensis (150 mg) twice a day during 90 days, and 12 patients received placebo. Glucose and insulin concentrations were measured during a 2-h oral glucose tolerance test...
January 16, 2018: Journal of Medicinal Food
https://www.readbyqxmd.com/read/29336109/moderate-hypofractionation-for-prostate-cancer-a-user-s-guide
#18
REVIEW
David I Pryor, Sandra L Turner, Keen Hun Tai, Colin Tang, Giuseppe Sasso, Marcus Dreosti, Henry H Woo, Lee Wilton, Jarad M Martin
Three large randomised controlled trials have been published in the last year demonstrating the non-inferiority of moderate hypofractionation compared to conventional fractionation for localised prostate cancer with respect to both disease control and late toxicity at 5 years. Furthermore, no clinically significant differences in patient-reported outcomes have emerged. More mature follow-up data are now also available from phase 2 studies confirming that moderate hypofractionation is associated with low rates of significant toxicity at 10 years...
January 16, 2018: Journal of Medical Imaging and Radiation Oncology
https://www.readbyqxmd.com/read/29334758/anticancer-thiosemicarbazones-chemical-properties-interaction-with-iron-metabolism-and-resistance-development
#19
Petra Heffeter, Veronika F S Pape, Eva A Enyedy, Bernhard K Keppler, Gergely Szakas, Christian R Kowol
SIGNIFICANCE: During the last decades, thiosemicarbazones have been clinically developed for a variety of diseases including tuberculosis, viral infections, malaria and cancer. With regard to malignant diseases, the class of α-N-heterocyclic thiosemicarbazones, and here especially Triapine, was intensively developed in multiple clinical phase I/II trials. Recent Advances: Very recently two new derivatives, namely COTI-2 and DpC have entered phase I evaluation. Based on the strong metal-chelating/metal-interacting properties of thiosemicarbazones, interference with the cellular iron (and copper) homeostasis is assumed to play an important role in their biological activity...
January 15, 2018: Antioxidants & Redox Signaling
https://www.readbyqxmd.com/read/29333575/a-phase-1-dose-escalation-study-of-pf-06664178-an-anti-trop-2-aur0101-antibody-drug-conjugate-in-patients-with-advanced-or-metastatic-solid-tumors
#20
Gentry T King, Keith D Eaton, Brandon R Beagle, Christopher J Zopf, Gilbert Y Wong, Heike I Krupka, Steven Y Hua, Wells A Messersmith, Anthony B El-Khoueiry
Purpose and Methods Trop-2 is a glycoprotein over-expressed in many solid tumors but at low levels in normal human tissue, providing a potential therapeutic target. We conducted a phase 1 dose-finding study of PF-06664178, an antibody-drug conjugate that targets Trop-2 for the selective delivery of the cytotoxic payload Aur0101. The primary objective was to determine the maximum tolerated dose and recommended phase 2 dose. Secondary objectives included further characterization of the safety profile, pharmacokinetics and antitumor activity...
January 15, 2018: Investigational New Drugs
keyword
keyword
18419
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"