Design of a drug-drug interaction study of vincristine with azole antifungals in pediatric cancer patients using clinical trial simulation

Pediatric Blood and Cancer

Volumn 61, Issue 12, 2014, Pages 2223-2229

  van Hasselt, J G Coen ^a,d   van Eijkelenburg, Natasha K A ^b   Beijnen, Jos H ^a,c   Schellens, Jan H M ^a,c   Huitema, Alwin D R ^a  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

^d LEIDEN UNIVERSITY   (Netherlands)

Author keywords

Clinical trial simulation; Pediatric oncology; Pharmacokinetics; Vincristine

Indexed keywords

ANTIFUNGAL AGENT; ANTINEOPLASTIC AGENT; PYRROLE DERIVATIVE; VINCRISTINE;

ADOLESCENT; ADULT; ALGORITHM; BIOLOGICAL MODEL; CHILD; CLINICAL TRIAL (TOPIC); COMPUTER SIMULATION; DRUG CONTAMINATION; DRUG INTERACTION; HUMAN; INFANT; METABOLISM; METHODOLOGY; MIDDLE AGED; NEOPLASMS; NEWBORN; PRESCHOOL CHILD; YOUNG ADULT;

ADOLESCENT; ADULT; ALGORITHMS; ANTIFUNGAL AGENTS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; AZOLES; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DRUG CONTAMINATION; DRUG INTERACTIONS; HUMANS; INFANT; INFANT, NEWBORN; MIDDLE AGED; MODELS, BIOLOGICAL; NEOPLASMS; RESEARCH DESIGN; VINCRISTINE; YOUNG ADULT;

EID: 84911478374     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.25198     Document Type: Article

References (30)

1. Moore AS, Norris R, Price G, et al. Vincristine pharmacodynamics and pharmacogenetics in children with cancer: A limited-sampling, population modelling approach. J Paediatr Child Health 2011; 47:875-882.
2. Gidding CE, Meeuwsen-de Boer GJ, Koopmans P, et al. Vincristine pharmacokinetics after repetitive dosing in children. Cancer Chemother Pharmacol 1999; 44:203-209.
3. Teusink AC, Ragucci D, Shatat IF, et al. Potentiation of vincristine toxicity with concomitant fluconazole prophylaxis in children with acute lymphoblastic leukemia. Pediatr Hematol Oncol 2012; 29:62-67.
4. Van Schie RM, Brüggemann RJM, Hoogerbrugge PM, et al. Effect of azole antifungal therapy on vincristine toxicity in childhood acute lymphoblastic leukaemia. J Antimicrob Chemother 2011; 66:1853-1856.
5. Bermúdez M, Fuster JL, Llinares E, et al. Itraconazole-related increased vincristine neurotoxicity: Case report and review of literature. J Pediatr Hematol Oncol 2005; 27:389-392.
6. Pana ZD, Roilides E. Risk of azole-enhanced vincristine neurotoxicity in pediatric patients with hematological malignancies: Old problem - new dilemma. Pediatr Blood Cancer 2011; 57:30-35.
7. Harnicar S, Adel N, Jurcic J. Modification of vincristine dosing during concomitant azole therapy in adult acute lymphoblastic leukemia patients. J Oncol Pharm Pract 2009; 15:175-182.
8. Van Hasselt JGC, van Eijkelenburg NKA, Beijnen JH, et al. Optimizing drug development of anti-cancer drugs in children using modelling and simulation. Br J Clin Pharmacol 2013; 76:30-47.
9. Van Hasselt JGC, Andrew MA, Hebert MF, et al. The status of pharmacometrics in pregnancy: Highlights from the 3(rd) American Conference on Pharmacometrics. Br J Clin Pharmacol 2012; 74:932-939.
10. Kimko H, Duffull SB. Simulation for designing clinical trials: A pharmacokinetic-pharmacodynamic modeling perspective. Boca Raton, FL: CRC Press; 2002.
11. Holford N, Ma SC, Ploeger BA. Clinical trial simulation: A review. Clin Pharmacol Ther 2010; 88:166-182.
12. Cella M, Danhof M, Della Pasqua O. Adaptive trials in paediatric development: Dealing with heterogeneity and uncertainty in pharmacokinetic differences in children. Br J Clin Pharmacol 2012; 74:346-353.
13. Mouksassi MS, Marier JF, Cyran J, et al. Clinical trial simulations in pediatric patients using realistic covariates: Application to teduglutide, a glucagon-like peptide-2 analog in neonates and infants with short-bowel syndrome. Clin Pharmacol Ther 2009; 86:667-671.
14. Laughon MM, Benjamin DK, Capparelli EV, et al. Innovative clinical trial design for pediatric therapeutics. Expert Rev Clin Pharmacol 2011; 4:643-652.
15. Piana C, Zhao W, Adkison K, et al. A model-based approach for the evaluation of once daily dosing of lamivudine in HIV-infected children. Br J Clin Pharmacol 2014; 77:852-860.
16. Jeena PM, Bishai WR, Pasipanodya JG, et al. In silico children and the glass mouse model: Clinical trial simulations to identify and individualize optimal isoniazid doses in children with tuberculosis. Antimicrob Agents Chemother 2011; 55:539-545.
17. Duffull SB, Denman N, Eccleston J, et al. WinPOPT User Guide Version 1.2, 2008.
18. CDC.U. Growth Charts - Homepage [Internet][cited 2013 Aug 23] Available from: http://www.cdc.gov/growthcharts/.
19. World Health Organization. WHO The WHO Child Growth Standards, 2006.
20. Control USC for D. Growth Charts - Percentile Data Files with LMS Values, 2000.
21. De Graaf SS, Bloemhof H, Vendrig DE, et al. Vincristine disposition in children with acute lymphoblastic leukemia. Med Pediatr Oncol 1995; 24:235-240.
22. Guilhaumou R, Simon N, Quaranta S, et al. Population pharmacokinetics and pharmacogenetics of vincristine in paediatric patients treated for solid tumour diseases. Cancer Chemother Pharmacol 2011; 68:1191-1198.
23. Groninger E, Meeuwsen-de Boar T, Koopmans P, et al. Pharmacokinetics of vincristine monotherapy in childhood acute lymphoblastic leukemia. Pediatr Res 2002; 52:113-118.
24. Karlsson KE, Vong C, Bergstrand M, et al. Comparisons of analysis methods for proof-of-concept trials. CPT: Pharmacometrics & Systems Pharmacology 2013; 2:e23.
25. Groninger E, Proost JH, de Graaf SSN. Pharmacokinetic studies in children with cancer. Crit Rev Oncol Hematol 2004; 52:173-197.
26. Van Hasselt JGC, Schellens JHM, Beijnen JH, et al. Design of informative renal impairment studies: Evaluation of the impact of design stratification on bias, precision and dose adjustment error. Invest New Drugs 2014. doi: 10.1007/s10637-014-0103-8 [Epub ahead of print].
27. Anderson BJ, Holford NHG. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 2008; 48:303-332.
28. Duffull SB. Design of clinical pharmacology trials. Clin Exp Pharmacol Physiol 2001; 28:905-912.
29. Van Hasselt JGC, Green B, Morrish GA. Leveraging physiological data from literature into a pharmacokinetic model to support informative clinical study design in pregnant women. Pharm Res 2012; 29:1609-1617.
30. Berry DA. Adaptive clinical trials in oncology. Nat Rev Clin Oncol 2012; 9:199-207.