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130 Newest Publications about the topic phase i studies


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Impact of race on dose selection of molecular-targeted agents in early-phase oncology trials

24-May-2018 | Tomoya Yokota; Johanna Bendell; Patricia LoRusso; Takahiro Tsushima; Ved Desai; Hirotsugu Kenmotsu; Junichiro Watana ..., British Journal of Cancer, 2018

We examined the impact of race on the maximum tolerated doses (MTD) and final approved doses (FAD) of single-agent molecular-targeted agents (MTA) in North America/Europe (NA/EU) and Asia. We searched PubMed and regulatory databases to identify targeted drugs approved globally and compared their ...


Phase I studies of AZD1208, a proviral integration Moloney virus kinase inhibitor in solid and haematological cancers

16-May-2018 | Jorge Cortes; Kenji Tamura; Daniel J. DeAngelo; Johann de Bono; David Lorente; Mark Minden; Geoffrey L. Uy; Hagop Ka ..., British Journal of Cancer, 2018

Proviral integration Moloney virus (PIM) kinases (PIM1, 2 and 3) are overexpressed in several tumour types and contribute to oncogenesis. AZD1208 is a potent ATP-competitive PIM kinase inhibitor investigated in patients with recurrent or refractory acute myeloid leukaemia (AML) or advanced solid ...


Population pharmacokinetics of the MEK inhibitor selumetinib and its active N‐desmethyl metabolite: data from ten Phase I trials

23-Aug-2017 | Parul Patel, Eleanor Howgate, Paul Martin, David J. Carlile, Leon Aarons, Diansong Zhou, British Journal of Clinical Pharmacology, 2017

Summary Aims To characterise the pharmacokinetics (PK) of selumetinib (AZD6244; ARRY‐142886), a MEK1/2 inhibitor in clinical development for numerous indications, and its N‐desmethyl metabolite in healthy volunteers, and evaluate clinically important covariates. Methods A ...


Single‐Dose and Multiple‐Dose Pharmacokinetics of Vaniprevir in Healthy Men

10-Aug-2017 | L Caro, J Hoon, M Depré, C Cilissen, J Miller, W Gao, D Panebianco, Z Guo, SL Troemel, MS Anderson, N Uemura, J Butt ..., Clinical and Translational Science, 2017

Vaniprevir is an inhibitor of the hepatitis C virus (HCV) NS3/4A protease. The aim of these double‐blind, placebo‐controlled phase I studies was to evaluate the safety and pharmacokinetics of vaniprevir in healthy male volunteers. The primary objective for both studies was the safety and ...


Pharmacokinetics, pharmacodynamics and adverse event profile of GSK2256294, a novel soluble epoxide hydrolase inhibitor

01-Dec-2015 | Aili L. Lazaar, Lucy Yang, Rebecca L. Boardley, Navin S. Goyal, Jonathan Robertson, Sandra J. Baldwin, David E. Newb ..., British Journal of Clinical Pharmacology, 2015

Abstract Aims Endothelial‐derived epoxyeicosatrienoic acids may regulate vascular tone and are metabolised by soluble epoxide hydrolase enzymes (sEH). GSK2256294 is a potent and selective sEH inhibitor that was tested in two Phase I studies. Methods Single escalating doses of ...


Population Pharmacokinetics of Nalmefene in Healthy Subjects and its Relation to μ‐Opioid Receptor Occupancy

20-Oct-2015 | Lars‐Erik Broksø Kyhl, Shen Li, Kirstine Ullitz Faerch, Birgitte Soegaard, Frank Larsen, Johan Areberg, British Journal of Clinical Pharmacology, 2015

Aims The aims of this study were to develop a population pharmacokinetic model to describe the pharmacokinetics of nalmefene in healthy subjects and to relate the exposure of nalmefene to the μ‐opioid receptor occupancy by simulations in the target population. Methods Data from nine ...


How to Manage Intravenous Vinflunine in Cancer Patients with Renal Impairment: Results of a Pharmacokinetic and Tolerability Phase I Study

30-Jul-2013 | Nicolas Isambert, Jean Pierre Delord, Jean Marc Tourani, Pierre Fumoleau, Alain Ravaud, Marie Claire Pinel, Aurelie ..., British Journal of Clinical Pharmacology, 2013

Abstract Aims Vinflunine (VFL) ditartrate, a novel tubulin‐targeted inhibitor is registered for the treatment of patients with advanced or metastatic urothelial transitional cell carcinoma. This phase I study assessed the effect of renal impairment on the pharmacokinetics and tolerability of ...


A phase I study of the combination of ro4929097 and cediranib in patients with advanced solid tumours (PJC-004|[sol]|NCI 8503)

18-Jul-2013 | S Sahebjam, P L Bedard, V Castonguay, Z Chen, M Reedijk, G Liu, B Cohen, W-J Zhang, B Clarke, T Zhang, S Kamel-Reid, ..., British Journal of Cancer, 2013

A phase I study of the combination of ro4929097 and cediranib in patients with advanced solid tumours (PJC-004/NCI 8503) British Journal of Cancer advance online publication, July 18 2013. doi:10.1038/bjc.2013.380 Authors: S Sahebjam, P L Bedard, V Castonguay, Z Chen, M Reedijk, G ...


Population pharmacokinetic analysis of axitinib in healthy volunteers

09-Jul-2013 | May Garrett, Bill Poland, Meghan Brennan, Brian Hee, Yazdi K. Pithavala, Michael A. Amantea, British Journal of Clinical Pharmacology, 2013

Summary Aims Axitinib is a potent and selective second‐generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 approved for second‐line treatment of advanced renal cell carcinoma. The objectives of this analysis were to assess plasma pharmacokinetics and identify ...


Pharmacokinetic properties of isradipine after single‐dose and multiple‐dose oral administration in Chinese volunteers: a randomized, open‐label, parallel‐group phase I study

01-Jul-2013 | Yanran Wang, Zhaohui Jin, Zhijun Wang, Xuehua Jiang, Ling Wang, Biomedical Chromatography, 2013

ABSTRACT Isradipine could be used for the treatment of high blood pressure or Parkinsonism, yet the study on pharmacokinetics (PK) of isradipine is lacking in the Chinese population. The current study aims to assess the dose proportionality, pharmacokinetics and gender effect of isradipine ...


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