The effect of food on the pharmacokinetics of oral ibrutinib in healthy participants and patients with chronic lymphocytic leukemia

Cancer Chemotherapy and Pharmacology

Volumn 75, Issue 5, 2015, Pages 907-916

  De Jong, Jan ^a   Sukbuntherng, Juthamas ^b   Skee, Donna ^a   Murphy, Joe ^a   O'Brien, Susan ^c   Byrd, John C ^d   James, Danelle ^b   Hellemans, Peter ^e   Loury, David J ^b   Jiao, Juhui ^a   Chauhan, Vijay ^a   Mannaert, Erik ^e  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b PHARMACYCLICS INC   (United States)

^c UNIVERSITY OF TEXAS   (United States)

^d OHIO STATE UNIVERSITY   (United States)

^e JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Chronic lymphocytic leukemia; Food effect; Ibrutinib; Pharmacokinetics; Tyrosine kinase inhibitor

Indexed keywords

IBRUTINIB; PYRAZOLE DERIVATIVE; PYRIMIDINE DERIVATIVE;

ADULT; AGED; BLOOD; CASE CONTROL STUDY; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; FEMALE; FOOD DRUG INTERACTION; HUMAN; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; METABOLISM; MIDDLE AGED; ORAL DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL; VERY ELDERLY;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; CASE-CONTROL STUDIES; CROSS-OVER STUDIES; FASTING; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; PYRAZOLES; PYRIMIDINES;

EID: 84939953262     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-015-2708-9     Document Type: Article

References (23)

1. Byrd JC, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum KA, Grant B, Sharman JP, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Sukbuntherng J, Chang BY, Clow F, Hedrick E, Buggy JJ, James DF, O'Brien S (2013) Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med 369:32-42. doi: 10.1056/NEJMoa1215637
2. Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA (2013) Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med 369:507-516. doi: 10.1056/NEJMoa1306220
3. Dipiro J, Talbert R, Yee G, Matzke G, Wells B (eds) (2008) Pharmacotherapy: a pathophysiologic approach, 7th edn. McGraw Hill Medical, New York, p 2559
4. Siegel R, Naishadham D, Jemal A (2013) Cancer statistics, 2013. CA Cancer J Clin 63:11-30. doi: 10.3322/caac.21166
5. Rinaldi A, Kwee I, Taborelli M, Largo C, Uccella S, Martin V, Poretti G, Gaidano G, Calabrese G, Martinelli G, Baldini L, Pruneri G, Capella C, Zucca E, Cotter FE, Cigudosa JC, Catapano CV, Tibiletti MG, Bertoni F (2006) Genomic and expression profiling identifies the B-cell associated tyrosine kinase Syk as a possible therapeutic target in mantle cell lymphoma. Br J Haematol 132:303-316
6. Gribben JG, O'Brien S (2011) Update on therapy of chronic lymphocytic leukemia. J Clin Oncol 29:544-550. doi: 10.1200/JCO.2010.32.3865
7. Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P, RESONATE Investigators (2014) Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med 371:213-223. doi: 10.1056/NEJMoa1400376
8. Wierda W, O'Brien S, Wen S, Faderl S, Garcia-Manero G, Thomas D, Do KA, Cortes J, Koller C, Beran M, Ferrajoli A, Giles F, Lerner S, Albitar M, Kantarjian H, Keating M (2005) Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia. J Clin Oncol 23:4070-4078
9. Byrd JC, Rai K, Peterson BL, Appelbaum FR, Morrison VA, Kolitz JE, Shepherd L, Hines JD, Schiffer CA, Larson RA (2005) Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011. Blood 105:49-53
10. Wiestner A (2012) Emerging role of kinase-targeted strategies in chronic lymphocytic leukemia. Blood 120:4684-4691. doi: 10.1182/blood-2012-05-423194
11. Wiestner A (2013) Targeting B-Cell receptor signaling for anticancer therapy: the Bruton's tyrosine kinase inhibitor ibrutinib induces impressive responses in B-cell malignancies. J Clin Oncol 31:128-130. doi: 10.1200/JCO.2012.44.4281
12. Gururajan M, Jennings CD, Bondada S (2006) Cutting edge: constitutive B cell receptor signaling is critical for basal growth of B lymphoma. J Immunol 176:5715-5719
13. Stevenson FK, Krysov S, Davies AJ, Steele AJ, Packham G (2011) B-cell receptor signaling in chronic lymphocytic leukemia. Blood 118:4313-4320. doi: 10.1182/blood-2011-06-338855
14. Satterthwaite AB, Cheroutre H, Khan WN, Sideras P, Witte ON (1997) Btk dosage determines sensitivity to B cell antigen receptor cross-linking. Proc Natl Acad Sci USA 94:13152-13157
15. Buggy JJ, Elias L (2012) Bruton tyrosine kinase (BTK) and its role in B-cell malignancy. Int Rev Immunol 31:119-132. doi: 10.3109/08830185.2012.664797
16. Jefferies CA, Doyle S, Brunner C, Dunne A, Brint E, Wietek C, Walch E, Wirth T, O'Neill LA (2003) Bruton's tyrosine kinase is a Toll/interleukin-1 receptor domain-binding protein that participates in nuclear factor kappaB activation by Toll-like receptor 4. J Biol Chem 278:26258-26264
17. Conley ME, Dobbs AK, Farmer DM, Kilic S, Paris K, Grigoriadou S, Coustan-Smith E, Howard V, Campana D (2009) Primary B cell immunodeficiencies: comparisons and contrasts. Annu Rev Immunol 27:199-227. doi: 10.1146/annurev.immunol.021908.132649
18. Honigberg LA, Smith AM, Sirisawad M, Verner E, Loury D, Chang B, Li S, Pan Z, Thamm DH, Miller RA, Buggy JJ (2010) The Bruton tyrosine kinase inhibitor PCI-32765 blocks B-cell activation and is efficacious in models of autoimmune disease and B-cell malignancy. Proc Natl Acad Sci USA 107:13075-13080. doi: 10.1073/pnas.1004594107
19. Herman SE, Gordon AL, Hertlein E, Ramanunni A, Zhang X, Jaglowski S, Flynn J, Jones J, Blum KA, Buggy JJ, Hamdy A, Johnson AJ, Byrd JC (2011) Bruton tyrosine kinase represents a promising therapeutic target for treatment of chronic lymphocytic leukemia and is effectively targeted by PCI-32765. Blood 117:6287-6296. doi: 10.1182/blood-2011-01-328484
20. Ponader S, Chen SS, Buggy JJ, Balakrishnan K, Gandhi V, Wierda WG, Keating MJ, O'Brien S, Chiorazzi N, Burger JA (2012) The Bruton tyrosine kinase inhibitor PCI-32765 thwarts chronic lymphocytic leukemia cell survival and tissue homing in vitro and in vivo. Blood 119:1182-1189. doi: 10.1182/blood-2011-10-386417
21. Advani RH, Buggy JJ, Sharman JP, Smith SM, Boyd TE, Grant B, Kolibaba KS, Furman RR, Rodriguez S, Chang BY, Sukbuntherng J, Izumi R, Hamdy A, Hedrick E, Fowler NH (2013) Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol 31:88-94. doi: 10.1200/JCO.2012.42.7906
22. Kang SP, Ratain MJ (2010) Inconsistent labeling of food effect for oral agents across therapeutic areas: differences between oncology and non-oncology products. Clin Cancer Res 16:4446-4451. doi: 10.1158/1078-0432.CCR-10-0663
23. Marostica E, Sukbuntherng J, Loury D, de Jong J, de Trixhe XW, Vermeulen A, De Nicolao G, O'Brien S, Byrd JC, Advani R, McGreivy J, Poggesi I (2015) Population pharmacokinetic model of ibrutinib, a Bruton tyrosine kinase inhibitor, in patients with B cell malignancies. Cancer Chemother Pharmacol 75:111-121. doi: 10.1007/s00280-014-2617-3