Pharmacokinetic profile of temsirolimus with concomitant administration of cytochrome P450-inducing medications

Journal of Clinical Pharmacology

Volumn 47, Issue 11, 2007, Pages 1430-1439

  Boni, Joseph ^a   Leister, Cathie ^b   Burns, Jaime ^b   Cincotta, Maria ^b   Hug, Bruce ^b   Moore, Laurence ^b  

^a PFIZER INC   (United States)

^b NONE

Author keywords

CYP3A; Cytochrome P450; Pharmacokinetics; Rifampin; Temsirolimus

Indexed keywords

CARBAMAZEPINE; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DEXAMETHASONE; DIPHENHYDRAMINE; ENZYME INDUCING AGENT; PHENOBARBITAL; PHENYTOIN; PRIMIDONE; RAPAMYCIN; RIFAMPICIN; TEMSIROLIMUS;

ACNE; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BRAIN METASTASIS; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG ERUPTION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; ENZYME SUBSTRATE; FEMALE; GLIOBLASTOMA; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; LEUKOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MUCOSA INFLAMMATION; NORMAL HUMAN; PAIN; PHARMACOKINETICS; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; TRIACYLGLYCEROL BLOOD LEVEL;

ADOLESCENT; ADULT; AGED; CYTOCHROME P-450 ENZYME SYSTEM; ENZYME INDUCTION; FEMALE; GLIOMA; HUMANS; MALE; MIDDLE AGED; PROTEIN KINASE INHIBITORS; PROTEIN KINASES; RIFAMPIN; SIROLIMUS;

EID: 35448978367     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270007306957     Document Type: Article

References (25)

1. Li AP, Kaminski DL, Rasmussen A. Substrates of human hepatic cytochrome P450 3A4. Toxicology. 1995 ; 104: 1-8.
2. Luo G., Guenthner T., Gan LS, Humphreys WG CYP3A4 induction by xenobiotics: biochemistry, experimental methods and impact on drug discovery and development. Curr Drug Metab. 2004 ; 5: 483-505.
3. Bolt HM Rifampicin, a keystone inducer of drug metabolism: from Herbert Remmer's pioneering ideas to modern concepts. Drug Metab Rev. 2004 ; 36: 497-509.
4. Niemi M., Backman JT, Fromm MF, Neuvonen PJ, Kivisto KT Pharmacokinetic interactions with rifampicin: clinical relevance. Clin Pharmacokinet. 2003 ; 42: 819-850.
5. Bjornsti MA, Houghton PJ The TOR pathway: a target for cancer therapy. Nat Rev Cancer. 2004 ; 4: 335-348.
6. Faivre S., Kroemer G., Raymond E. Current development of mTOR inhibitors as anticancer agents. Nat Rev Drug Discov. 2006 ; 5: 671-688.
7. DelBufalo D., Ciuffreda L., Trisciuoglio D., et al. Antiangiogenic potential of the mammalian target of rapamycin inhibitor temsirolimus. Cancer Res. 2006 ; 66: 5549-5554.
8. Thomas GV, Tran C., Mellinghoff IK, et al. Hypoxia-inducible factor determines sensitivity to inhibitors of mTOR in kidney cancer. Nat Med. 2006 ; 12: 122-127.
9. Atkins MB, Hidalgo M., Stadler WM, et al. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol. 2004 ; 22: 909-918.
10. Chan S., Scheulen ME, Johnston S., et al. Phase II study of temsirolimus (CCI-779), a novel inhibitor of mTOR, in heavily pretreated patients with locally advanced or metastatic breast cancer. J Clin Oncol. 2005 ; 23: 5314-5322.
11. Chang SM, Wen P., Cloughesy T., et al. Phase II study of CCI-779 in patients with recurrent glioblastoma multiforme. Invest New Drugs. 2005 ; 23: 357-361.
12. Galanis E., Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI-779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group Study. J Clin Oncol. 2005 ; 23: 5294-5304.
13. Teachey DT, Obzut DA, Cooperman J., et al. The mTOR inhibitor CCI-779 induces apoptosis and inhibits growth in preclinical models of primary adult human ALL. Blood. 2006 ; 107: 1149-1155.
14. Witzig TE, Geyer SM, Ghobrial I., et al. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005 ; 23: 5347-5356.
15. Boni JP, Leister C., Bender G., et al. Population pharmacokinetics of CCI-779: correlations to safety and pharmacogenomic responses in patients with advanced renal cancer. Clin Pharmacol Ther. 2005 ; 77: 76-89.
16. Peralba JM, DeGraffenried L., Friedrichs W., et al. Pharmacodynamic evaluation of CCI-779, an inhibitor of mTOR, in cancer patients. Clin Cancer Res. 2003 ; 9: 2887-2892.
17. Punt CJ, Boni J., Bruntsch U., Peters M., Thielert C. Phase I and pharmacokinetic study of CCI-779, a novel cytostatic cell-cycle inhibitor, in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors. Ann Oncol. 2003 ; 14: 931-937.
18. Raymond E., Alexandre J., Faivre S., et al. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol. 2004 ; 22: 2336-2347.
19. Hebert MF, Fisher RM, Marsh CL, Dressler D., Bekersky I. Effects of rifampin on tacrolimus pharmacokinetics in healthy volunteers. J Clin Pharmacol. 1999 ; 39: 91-96.
20. van Duijnhoven EM, Boots JM, Christiaans MH, Stolk LM, Undre NA, van Hooff JP. Increase in tacrolimus trough levels after steroid withdrawal. Transpl Int. 2003 ; 16: 721-725.
21. Kovarik JM, Beyer D., Schmouder RL Everolimus drug interactions: application of a classification system for clinical decision making. Biopharm Drug Dispos. 2006 ; 27: 421-426.
22. Chang SM, Kuhn J., Wen P., et al. Phase I/pharmacokinetic study of CCI-779 in patients with recurrent malignant glioma on enzyme-inducing antiepileptic drugs. Invest New Drugs. 2004 ; 22: 427-435.
23. Therasse P., Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 ; 92: 205-216.
24. Jusko WJ Guidelines for collection and analysis of pharmacokinetic data. In: Evans WE, Schentag JJ, Jusko WJ, eds. Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. 3 rd ed. Vancouver, Wash: Applied Therapeutics ; 1992 :2-1-2-43.
25. Tsunoda SM, Velez RL, von Moltke LL, Greenblatt DJ Differentiation of intestinal and hepatic cytochrome P450 3A activity with use of midazolam as an in vivo probe: effect of ketoconazole. Clin Pharmacol Ther. 1999 ; 66: 461-471.