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A phase II study of the 5-lipoxygenase inhibitor, CV6504, in advanced pancreatic cancer: Correlation of clinical data with pharmacokinetic and pharmacodynamic endpoints (2000)

Ferry, D. R. ; Deakin, M. ; Baddeley, J. ; [et al.]

Springer

Annals of oncology 11 (2000), S. 1165-1170

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ISSN: 1569-8041

Keywords: inhibitor ; lipoxygenase ; pancreatic

Source: Springer Online Journal Archives 1860-2000

Topics: Medicine

Notes: Abstract Purpose:Primary objective was to determine response rate ofpatients with advanced pancreatic cancer to a novel lipoxygenase andthromboxane A2 synthetase inhibitor (CV6504); secondary objectives includedestimation of pharmacokinetics of CV6504, target-enzyme inhibition, safety andtolerance, quality of life and survival. Patients and methods:Thirty-one patients with advanced pancreaticcancer were planned to receive CV6504, 100 mg TDS, orally for three months,at which point CT scans were performed to assess therapeutic response rates.Steady state concentrations of CV6504 and thromboxane B2 (an indirect measureof thromboxane A2 synthetase (TA2S) inhibition) were made. Of the31 patients entered into the study, 23 were considered fully evaluable forresponse. Results:The drug was well tolerated with few side effects; nopartial or complete responses were seen, but 10 patients had stable diseaseat 3 months; quality of life was maintained during therapy; mean CV6504 steadystate plasma concentrations of 14 ± 6 ng/ml resulting in 75 ±18% inhibition of TA2S were achieved; median-survival timefor all patients considered eligible for assessment of efficacy was 36.6 weeksafter the initial dose of study medication. The actuarial one-year survivalwas approximately 25%. Conclusion:CV6504 inhibits its target enzyme in vivo,maintains stable disease in 32% of evaluable patients and is welltolerated.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1023/A:1008303715515

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[s.l.] : Nature Publishing Group

Nature 347 (1990), S. 584-585

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ISSN: 1476-4687

Source: Nature Archives 1869 - 2009

Topics: Biology , Chemistry and Pharmacology , Medicine , Natural Sciences in General , Physics

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