Two-dose-level confirmatory study of the pharmacokinetics and tolerability of everolimus in Chinese patients with advanced solid tumors

Journal of Hematology and Oncology

Volumn 4, Issue , 2011, Pages

  Xu, Binghe ^a   Wu, Yilong ^b   Shen, Lin ^c   Ye, Dingwei ^d   Jappe, Annette ^e   Cherfi, Azzeddine ^e   Wang, Hui ^f   Yuan, Ruirong ^e,g  

^a CANCER HOSPITAL   (China)

^b Guandong General Hospital   (China)

^c PEKING UNIVERSITY CANCER HOSPITAL AND INSTITUTE   (China)

^d FUDAN UNIVERSITY   (China)

^e NOVARTIS PHARMA AG   (Switzerland)

^f Novartis Pharma Co Ltd   (China)

^g RUTGERS NEW JERSEY MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EVEROLIMUS; GLUCOSE; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; RAPAMYCIN;

ADULT; ADVANCED CANCER; ARTICLE; BREAST CANCER; CANCER PATIENT; CHINA; CLINICAL ARTICLE; DRUG ANALYSIS; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; KIDNEY CARCINOMA; LUNG NON SMALL CELL CANCER; MALE; MULTICENTER STUDY; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOLID TUMOR; STOMACH CANCER; TIME TO MAXIMUM PLASMA CONCENTRATION; AGED; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; METABOLISM; MIDDLE AGED; NEOPLASM; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; SIROLIMUS; TREATMENT OUTCOME;

EID: 78651288405     PISSN: None     EISSN: 17568722     Source Type: Journal    
DOI: 10.1186/1756-8722-4-3     Document Type: Article

References (27)

1. Upstream and downstream of mTOR. N Hay N Sonenberg, Genes Dev 2004 18 1926 1945 10.1101/gad.1212704 15314020
2. TOR signaling in growth and metabolism. S Wullschleger R Loewith MN Hall, Cell 2006 124 471 484 10.1016/j.cell.2006.01.016 16469695
3. Targeting von Hippel-Lindau pathway in renal cell carcinoma. PH Patel RS Chadalavada RS Chaganti RJ Motzer, Clin Cancer Res 2006 12 7215 7220 10.1158/1078-0432.CCR-06-2254 17189392
4. Targeting tumorigenesis: development and use of mTOR inhibitors in cancer therapy. R Yuan A Kay WJ Berg D Lebwohl, J Hematol Oncol 2009 2 45 10.1186/1756-8722-2-45 19860903
5. mTOR signalling in human cancer. J Albanell A Dalmases A Rovira F Rojo, Clin Transl Onco 2007 9 484 493 10.1007/s12094-007-0092-6
6. Therapeutic targets: MTOR and related pathways. JE Dancey, Cancer Biol Ther 2006 5 1065 1073 16969122
7. Role of mTOR in anticancer drug resistance: perspectives for improved drug treatment. BH Jiang LZ Liu, Drug Resist Updat 2008 11 63 76 10.1016/j.drup.2008.03.001 18440854
8. Cytostatic and anti-angiogenic effects of temsirolimus in refractory mantle cell lymphoma. L Wang WY Shi ZY Wu M Varna AH Wang L Zhou L Chen ZX Shen H Lu WL Zhao A Janin, J Hematol Oncol 2010 3 30 10.1186/1756-8722-3-30 20828385
9. Phase I pharmacokinetic and pharmacodynamic study of the oral mammalian target of rapamycin inhibitor everolimus in patients with advanced solid tumors. A O'Donnell S Faivre HA Burris D Rea V Papadimitrakopoulou N Shand HA Lane K Hazell U Zoellner JM Kovarik C Brock S Jones E Raymond I Judson, J Clin Oncol 2008 26 1588 1595 18332470
10. Afinitor (everolimus) tablets for oral administration [prescribing information]. Stein, Switzerland: Novartis Pharma Stein AG 2009
11. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. RJ Motzer B Escudier S Oudard TE Hutson C Porta S Bracarda V Grünwald JA Thompson RA Figlin N Hollaender A Kay A Ravaud RECORD-1 Study Group, Cancer 2010 116 4256 4265 10.1002/cncr.25219 20549832
12. The mTOR inhibitor RAD001 sensitizes tumor cells to DNA-damaged induced apoptosis through inhibition of p21 translation. I Beuvink A Boulay S Fumagalli F Zilbermann S Ruetz T O'Reilly F Natt J Hall HA Lane G Thomas, Cell 2005 120 747 759 10.1016/j.cell.2004.12.040 15797377
13. Antitumor activity of RAD001, an orally active rapamycin derivative [abstract 1972]. I Beuvink T O'Reilly S Zumstein F Zilbermann R Sedrani S Kozma G Thomas HA Lane, Proc Am Assoc Cancer Res 2001 42 366
14. In vivo activity of RAD001, an orally active rapamycin derivative, in experimental tumor models [abstract 349]. T O'Reilly J Vaxelaire M Muller HH Fiebig M Hattenberger HA Lane, Proc Am Assoc Cancer Res 2002 43 71
15. Dose- and schedule-dependent inhibition of the mammalian target of rapamycin pathway with everolimus: a phase I tumor pharmacodynamic study in patients with advanced solid tumors. J Tabernero F Rojo E Calvo H Burris I Judson K Hazell E Martinelli S Ramon y Cajal S Jones L Vidal N Shand T Macarulla FJ Ramos S Dimitrijevic U Zoellner P Tang M Stumm HA Lane D Lebwohl J Baselga, J Clin Oncol 2008 26 1603 1610 10.1200/JCO.2007.14.5482 18332469
16. Identifying optimal biologic doses of everolimus (RAD001) in patients with cancer based on the modeling of preclinical and clinical pharmacokinetic and pharmacodynamic data. C Tanaka T O'Reilly JM Kovarik N Shand K Hazell I Judson E Raymond S Zumstein-Mecker C Stephan A Boulay M Hattenberger G Thomas HA Lane, J Clin Oncol 2008 26 1596 1602 18332467
17. Phase I clinical and pharmacokinetic study of RAD001 (everolimus) administered daily to Japanese patients with advanced solid tumors. I Okamoto T Doi A Ohtsu M Miyazaki A Tsuya K Kurei K Kobayashi K Nakagawa, Jpn J Clin Oncol 2010 40 17 23 10.1093/jjco/hyp120 19783551
18. Cancer Institute/Hospital China Academy of Medical Science. China Cancer Database, 2004 http://cancernet.cicams.ac.cn/data/epi/monitor/disease-list.htm
19. Multicenter phase II study of everolimus in patients with previously treated metastatic gastric cancer. T Doi K Muro N Boku Y Yamada T Nishina H Takiuchi Y Komatsu Y Hamamoto N Ohno Y Fujita M Robson A Ohtsu, J Clin Oncol 2010 28 1904 1910 10.1200/JCO.2009.26.2923 20231677
20. Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. SL Ellard M Clemons KA Gelmon B Norris H Kennecke S Chia K Pritchard A Eisen T Vandenberg M Taylor E Sauerbrei M Mishaeli D Huntsman W Walsh M Olivo L McIntosh L Seymour, J Clin Oncol 2009 27 4536 4541 10.1200/JCO.2008.21.3033 19687332
21. Efficacy of everolimus (RAD001) in patients with advanced NSCLC previously treated with chemotherapy alone or with chemotherapy and EGFR inhibitors. JC Soria FA Shepherd JY Douillard J Wolf G Giaccone L Crino F Cappuzzo S Sharma SH Gross S Dimitrijevic L Di Scala H Gardner L Nogova V Papadimitrakopoulou, Ann Oncol 2009 20 1674 1681 10.1093/annonc/mdp060 19549709
22. Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0 National Cancer Institute 2006
23. 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. P Therasse SG Arbuck EA Eisenhauer J Wanders RS Kaplan L Rubinstein J Verweij M Van Glabbeke AT van Oosterom MC Christian SG Gwyther, J Natl Cancer Inst 2000 92 205 216 10.1093/jnci/92.3.205 10655437
24. Phase I trial of the novel mammalian target of rapamycin inhibitor deforolimus (AP23573; MK-8669) administered intravenously daily for 5 days every 2 weeks to patients with advanced malignancies. MM Mita AC Mita QS Chu EK Rowinsky GJ Fetterly M Goldston A Patnaik L Mathews AD Ricart T Mays H Knowles VM Rivera J Kreisberg CL Bedrosian AW Tolcher, J Clin Oncol 2008 26 361 367 10.1200/JCO.2007.12.0345 18202410
25. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. E Raymond J Alexandre S Faivre K Vera E Materman J Boni C Leister J Korth-Bradley A Hanauske JP Armand, J Clin Oncol 2004 22 2336 2347 10.1200/JCO.2004.08.116 15136596
26. A phase I trial of a novel mTOR inhibitor AP23573 administered weekly (wkly) in patients (pts) with refractory or advanced malignancies: a pharmacokinetic (PK) and pharmacodynamic (PD) analysis [abstract 3150]. AA Desai L Janisch LR Berk L Knowles VM Rivera CL Bedrosian MJ Ratain, J Clin Oncol 2004 22 232
27. Rapamycin: something old, something new, sometimes borrowed and now renewed. CM Hartford MJ Ratain, Clin Pharmacol Ther 2007 82 381 388 10.1038/sj.clpt.6100317 17728765