Mechanism-based pharmacokinetic/pharmacodynamic meta-analysis of navitoclax (ABT-263) induced thrombocytopenia

Cancer Chemotherapy and Pharmacology

Volumn 74, Issue 3, 2014, Pages 593-602

  Kaefer, Aksana ^a   Yang, Jianning ^a   Noertersheuser, Peter ^a   Mensing, Sven ^a   Humerickhouse, Rod ^a   Awni, Walid ^a   Xiong, Hao ^a  

^a ABBVIE INC   (United States)

Author keywords

ABT 263; Navitoclax; Pharmacodynamic model; Pharmacokinetic; Platelet; Thrombocytopenia

Indexed keywords

NAVITOCLAX; PROTEIN BCL 2;

APOPTOSIS; APPARENT DISTRIBUTION VOLUME; ARTICLE; BONE MARROW; CANCER PATIENT; CELL COMPARTMENTALIZATION; COMPARTMENT MODEL; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; FEEDBACK SYSTEM; HUMAN; META ANALYSIS; MULTIPLE CYCLE TREATMENT; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; STEM CELL; THROMBOCYTE COUNT; THROMBOCYTOPENIA;

ANILINE COMPOUNDS; ANTINEOPLASTIC AGENTS; BONE MARROW; HUMANS; MODELS, THEORETICAL; PLATELET COUNT; SULFONAMIDES; THROMBOCYTOPENIA;

EID: 84907597431     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-014-2530-9     Document Type: Article

References (13)

1. Wilson WH, O'Connor OA, Czuczman MS et al (2010) Navitoclax, a targeted high-affinity inhibitor of BCL-2, in lymphoid malignancies: a phase 1 dose-escalation study of safety, pharmacokinetics, pharmacodynamics, and antitumour activity. Lancet Oncol 11:1149-1159
2. Tse C, Schoemaker AR, Adickes J et al (2008) ABT-263: a potent and orally bioavailable Bcl-2 family inhibitor. Cancer Res 68(9):3421-3428
3. Gandhi L, Camidge DR, Ribeiro de Oliveira M, Bonomi P, Gandara D, Khaira D, Hann CL, McKeegan EM, Litvinovich E, Hemken PM, Dive C, Enschede SH, Nolan C, Chiu YL, Busman T, Xiong H, Krivoshik AP, Humerickhouse R, Shapiro GI, Rudin CM (2011) Phase I study of Navitoclax (ABT-263), a novel Bcl-2 family inhibitor, in patients with small-cell lung cancer and other solid tumors. J Clin Oncol 29(7):909-916. doi:10.1200/JCO.2010.31.6208JCO.2010.31.6208
4. Roberts AW, Seymour JF, Brown JR, Wierda WG, Kipps TJ, Khaw SL, Carney DA, He SZ, Huang DC, Xiong H, Cui Y, Busman TA, McKeegan EM, Krivoshik AP, Enschede SH, Humerickhouse R (2012) Substantial susceptibility of chronic lymphocytic leukemia to BCL2 inhibition: results of a phase I study of navitoclax in patients with relapsed or refractory disease. J Clin Oncol 30(5):488-496. doi:10.1200/JCO.2011.34.7898JCO.2011.34.7898
5. Davids MS, Letai A (2012) Targeting the B-cell lymphoma/leukemia 2 family in cancer. J Clin Oncol 30(25):3127-3135. doi:10.1200/JCO.2011.37.0981JCO.2011. 37.0981
6. Tomek M, Akiyama T, Dass CR (2012) Role of Bcl-2 in tumour cell survival and implications for pharmacotherapy. J Pharm Pharmacol 64(12):1695-1702. doi:10.1111/j.2042-7158.2012.01526.x
7. Roberts AW, Seymour JF, Brown JR et al (2012) Substantial susceptibility of chronic lymphocytic leukemia to BCL2 inhibition: results of a phase I study of navitoclax in patients with relapsed or refractory disease. J Clin Oncol 30:488-496
8. Eradat H, Grosicki S, Catalono J, Cosolo W, Dyagil I, Kipps TJ, Zheng B, Yalamanchili S, Sahasranaman S, Hurst D, Ho W, Pylypenko H (2012) Preliminary results of a Phase II open-label, randomized study of the BH3 mimetic protein navitoclax (ABT-263) with or without rituximab for treatment of previously untreated B-Cell chronic lymphocytic leukemia. Presented at ASH, 2012
9. Zhang H, Nimmer PM, Tahir SK et al (2007) Bcl-2 family proteins are essential for platelet survival. Cell Death Differ 14(5):943-951 (Pubitemid 46655455)
10. Friberg LE, Henningsson A, Maas H, Nguyen L, Karlsson MO (2002) Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. J Clin Oncol 20(24):4713-4721 (Pubitemid 36025290)
11. Quartino AL, Friberg LE, Karlsson MO (2010) A simultaneous analysis of the time-course of leukocytes and neutrophils following docetaxel administration using a semi-mechanistic myelosuppression model. Invest New Drugs 30(2):833-845
12. Serby M, Ahmed T, Yang J, Xiong H, Lee A, Shen J (2013) Metabolism and disposition of ABT-263 in humans. Paper presented at the Great Lakes Drug Metabolism Discussion Group annual meeting, Toledo, OH, May 9-10
13. Rai KR, Keating MJ(2000) Chronic lymphocytic leukemia. In: Bast Jr RC, Kufe DW, Pollock RE et al. (eds) Holland-Frei cancer medicine. 5th edition. BC Decker, Hamilton. Chapter 127