Application of hematological toxicity modeling in clinical development of abexinostat (S-78454, PCI-24781), A new histone deacetylase inhibitor

Pharmaceutical Research

Volumn 30, Issue 10, 2013, Pages 2640-2653

  Chalret Du Rieu, Quentin ^a,b   Fouliard, Sylvain ^a   Jacquet Bescond, Anne ^a   Robert, Renata ^a   Kloos, Ioana ^a   Depil, Stéphane ^a   Chatelut, Etienne ^b   Chenel, Marylore ^a  

^a IRIS Institut de Recherches Internationales Servier   (France)

^b UNIVERSITÉ PAUL SABATIER   (France)

Author keywords

abexinostat; NONMEM; population PK PD; simulations; thrombocytopenia

Indexed keywords

ABEXINOSTAT;

ACCURACY; ADULT; ADVANCED CANCER; AGED; ARTICLE; BLOOD SAMPLING; BLOOD TOXICITY; CLINICAL ARTICLE; CLINICAL PROTOCOL; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEALTH CARE PLANNING; HODGKIN DISEASE; HUMAN; LYMPHATIC LEUKEMIA; MALE; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NONHODGKIN LYMPHOMA; OUTCOME ASSESSMENT; PRIORITY JOURNAL; SINGLE DRUG DOSE; SOLID TUMOR; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION;

BENZOFURANS; CLINICAL TRIALS, PHASE I AS TOPIC; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HISTONE DEACETYLASE INHIBITORS; HUMANS; HYDROXAMIC ACIDS; MODELS, BIOLOGICAL; PLATELET COUNT; THROMBOCYTOPENIA;

EID: 84883894807     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-013-1089-1     Document Type: Article

References (31)

1. Batty N, Malouf GG, Issa JP. Histone deacetylase inhibitors as anti-neoplastic agents. Cancer Lett. 2009;280(2):192-200.
2. Marks P, Rifkind RA, Richon VM, Breslow R, Miller T, Kelly WK. Histone deacetylases and cancer: causes and therapies. Nat Rev Cancer. 2001;1(3):194-202.
3. Marks PA, Richon VM, Breslow R, Rifkind RA. Histone deacetylase inhibitors as new cancer drugs. Curr Opin Oncol. 2001;13(6):477-83.
4. Marks PA, Xu WS. Histone deacetylase inhibitors: potential in cancer therapy. J Cell Biochem. 2009;107(4):600-8.
5. Finnin MS, Donigian JR, Cohen A, Richon VM, Rifkind RA, Marks PA, et al. Structures of a histone deacetylase homologue bound to the TSA and SAHA inhibitors. Nature. 1999;401(6749):188-93.
6. Gui CY, Ngo L, Xu WS, Richon VM, Marks PA. Histone deacetylase (HDAC) inhibitor activation of p21WAF1 involves changes in promoter-associated proteins, including HDAC1. Proc Natl Acad Sci U S A. 2004;101(5):1241-6.
7. Stimson L, Wood V, Khan O, Fotheringham S, La Thangue NB. HDAC inhibitor-based therapies and haematological malignancy. Ann Oncol. 2009;20(8):1293-302.
8. Bishton MJ, Harrison SJ, Martin BP, McLaughlin N, James C, Josefsson EC, et al. Deciphering the molecular and biologic processes that mediate histone deacetylase inhibitor-induced thrombocytopenia. Blood. 2011;117(13):3658-68.
9. Giver CR, Jaye DL, Waller EK, Kaufman JL, Lonial S. Rapid recovery from panobinostat (LBH589)-induced thrombocytopenia in mice involves a rebound effect of bone marrow megakaryocytes. Leukemia. 2011;25(2):362-5.
10. Prince HM, Bishton MJ, Harrison SJ. Clinical studies of histone deacetylase inhibitors. Clin Cancer Res. 2009;15(12):3958-69.
11. Rubin EH, Agrawal NG, Friedman EJ, Scott P, Mazina KE, Sun L, et al. A study to determine the effects of food and multiple dosing on the pharmacokinetics of vorinostat given orally to patients with advanced cancer. Clin Cancer Res. 2006;12(23):7039-45.
12. Matsuoka H, Unami A, Fujimura T, Noto T, Takata Y, Yoshizawa K, et al. Mechanisms of HDAC inhibitor-induced thrombocytopenia. Eur J Pharmacol. 2007;571(2-3):88-96.
13. Horstmann E, McCabe MS, Grochow L, Yamamoto S, Rubinstein L, Budd T, et al. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med. 2005;352(9):895-904.
14. Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC. Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst. 1997;89(15):1138-47.
15. Friberg LE, Freijs A, Sandstrom M, Karlsson MO. Semiphysiological model for the time course of leukocytes after varying schedules of 5-fluorouracil in rats. J Pharmacol Exp Ther. 2000;295(2):734-40.
16. Friberg LE, Henningsson A, Maas H, Nguyen L, Karlsson MO. Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. J Clin Oncol. 2002;20(24):4713-21.
17. Panetta JC, Schaiquevich P, Santana VM, Stewart CF. Using pharmacokinetic and pharmacodynamic modeling and simulation to evaluate importance of schedule in topotecan therapy for pediatric neuroblastoma. Clin Cancer Res. 2008;14(1):318-25.
18. Schmitt A, Gladieff L, Laffont CM, Evrard A, Boyer JC, Lansiaux A, et al. Factors for hematopoietic toxicity of carboplatin: refining the targeting of carboplatin systemic exposure. J Clin Oncol. 2010;28(30):4568-74.
19. Soto E, Staab A, Tillmann C, Trommeshauser D, Fritsch H, Munzert G, et al. Semi-mechanistic population pharmacokinetic/pharmacodynamic model for neutropenia following therapy with the Plk-1 inhibitor BI 2536 and its application in clinical development. Cancer Chemother Pharmacol. 2010;66(4):785-95.
20. Zandvliet AS, Schellens JH, Dittrich C, Wanders J, Beijnen JH, Huitema AD. Population pharmacokinetic and pharmacodynamic analysis to support treatment optimization of combination chemotherapy with indisulam and carboplatin. Br J Clin Pharmacol. 2008;66(4):485-97.
21. Bender BC, Schaedeli-Stark F, Koch R, Joshi A, Chu YW, Rugo H, et al. A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer. Cancer Chemother Pharmacol. 2012;70(4):591-601.
22. Testart-Paillet D, Girard P, You B, Freyer G, Pobel C, Tranchand B. Contribution of modelling chemotherapy-induced hematological toxicity for clinical practice. Crit Rev Oncol Hematol. 2007;63(1):1-11.
23. Zhang L, Beal SL, Sheiner LB. Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn. 2003;30(6):387-404.
24. Lavielle M, Bleakley K. Automatic data binning for improved visual diagnosis of pharmacometric models. J Pharmacokinet Pharmacodyn. 2011;38(6):861-71.
25. Brendel K, Comets E, Laffont C, Laveille C, Mentre F. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res. 2006;23(9):2036-49.
26. Brendel K, Comets E, Laffont C, Mentre F. Evaluation of different tests based on observations for external model evaluation of population analyses. J Pharmacokinet Pharmacodyn. 2010;37(1):49-65.
27. Quartino AL, Friberg LE, Karlsson MO. A simultaneous analysis of the time-course of leukocytes and neutrophils following docetaxel administration using a semi-mechanistic myelosuppression model. Invest New Drugs. 2012;30(2):833-45.
28. Sundman-Engberg B, Tidefelt U, Paul C. Toxicity of cytostatic drugs to normal bone marrow cells in vitro. Cancer Chemother Pharmacol. 1998;42(1):17-23.
29. Zandvliet AS, Karlsson MO, Schellens JH, Copalu W, Beijnen JH, Huitema AD. Two-stage model-based clinical trial design to optimize phase I development of novel anticancer agents. Invest New Drugs. 2010;28(1):61-75.
30. Calvert AH, Plummer R. The development of phase I cancer trial methodologies: the use of pharmacokinetic and pharmacodynamic end points sets the scene for phase 0 cancer clinical trials. Clin Cancer Res. 2008;14(12):3664-9.
31. Zohar S, Chevret S. The continual reassessment method: comparison of Bayesian stopping rules for dose-ranging studies. Stat Med. 2001;20(19):2827-43.