Development of a modeling framework to simulate efficacy endpoints for motesanib in patients with thyroid cancer

Cancer Chemotherapy and Pharmacology

Volumn 66, Issue 6, 2010, Pages 1141-1149

  Claret, Laurent ^a   Lu, Jian Feng ^b   Sun, Yu Nien ^b   Bruno, René ^a  

^a A Certara Company   (France)

^b AMGEN INC   (United States)

Author keywords

Clinical endpoints; Motesanib; Simulation; Thyroid cancer

Indexed keywords

MOTESANIB;

AREA UNDER THE CURVE; ARTICLE; CANCER INHIBITION; CANCER MODEL; CONTROLLED STUDY; DIFFERENTIATED THYROID CANCER; DOSE RESPONSE; DRUG DOSE REDUCTION; HUMAN; MAJOR CLINICAL STUDY; MONOTHERAPY; OVERALL SURVIVAL; PRIORITY JOURNAL; PROBABILITY; PROGRESSION FREE SURVIVAL; SIMULATION; THYROID CANCER; THYROID MEDULLARY CARCINOMA; TREATMENT RESPONSE; TUMOR VOLUME;

ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INDOLES; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; MODELS, STATISTICAL; NIACINAMIDE; THYROID NEOPLASMS; TREATMENT OUTCOME;

EID: 78149412952     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-010-1449-z     Document Type: Article

References (19)

1. MJ Ratain RW Humphrey GB Gordon G Fyfe PC Adamson TR Fleming WM Stadler DA Berry CC Peck 2008 Recommended changes to oncology clinical trial design: revolution or evolution? Eur J Cancer 44 8 11 10.1016/j.ejca.2007.09.011 17981025 (Pubitemid 350258715)
2. R Leff M Andrews 2008 Predicting success in phase III studies from phase II results: a new paradigm is needed J Clin Oncol 26 3653 3654 10.1200/JCO.2008.17.5000 18640948 author reply 3654-3655
3. R Bruno L Claret 2009 On the use of change in tumor size to predict survival in clinical oncology studies: toward a new paradigm to design and evaluate phase II studies Clin Pharmacol Ther 86 136 138 1:CAS:528: DC%2BD1MXovFOrsbc%3D 10.1038/clpt.2009.97 19621009
4. Guidance for industry end-of-phase 2A meetings (2009) United States food and drug administration. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm079690.pdf. Accessed Aug 24 2009
5. L Claret P Girard J O'Shaughnessy P Hoff E Van Cutsem J Blum K Zuideveld K Jorga J Fagerberg R Bruno 2006 Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent [abstract] J Clin Oncol 24 6025
6. L Claret P Girard PM Hoff E Van Cutsem KP Zuideveld K Jorga J Fagerberg R Bruno 2009 Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics J Clin Oncol 27 4103 4108 1:CAS:528:DC%2BD1MXhtF2jtL3F 10.1200/JCO.2008.21.0807 19636014
7. Y Wang C Sung C Dartois R Ramchandani BP Booth E Rock J Gobburu 2009 Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development Clin Pharmacol Ther 86 167 174 1:CAS:528:DC%2BD1MXovFOrt7o%3D 10.1038/clpt.2009.64 19440187
8. A Polverino A Coxon C Starnes Z Diaz T DeMelfi L Wang J Bready J Estrada R Cattley S Kaufman D Chen Y Gan G Kumar J Meyer S Neervannan G Alva J Talvenheimo S Montestruque A Tasker V Patel R Radinsky R Kendall 2006 AMG 706, an oral, multikinase inhibitor that selectively targets vascular endothelial growth factor, platelet-derived growth factor, and kit receptors, potently inhibits angiogenesis and induces regression in tumor xenografts Cancer Res 66 8715 8721 1:CAS:528:DC%2BD28XovF2hs7w%3D 10.1158/0008-5472.CAN-05-4665 16951187 (Pubitemid 44449188)
9. LS Rosen R Kurzrock M Mulay A Van Vugt M Purdom C Ng J Silverman A Koutsoukos YN Sun MB Bass RY Xu A Polverino JS Wiezorek DD Chang R Benjamin RS Herbst 2007 Safety, pharmacokinetics, and efficacy of AMG 706, an oral multikinase inhibitor, in patients with advanced solid tumors J Clin Oncol 25 2369 2376 1:CAS:528:DC%2BD2sXns1KmtL0%3D 10.1200/JCO.2006.07.8170 17557949 (Pubitemid 46999207)
10. TJ Price L Lipton J McGreivy S McCoy YN Sun MA Rosenthal 2008 Safety and pharmacokinetics of motesanib in combination with gemcitabine for the treatment of patients with solid tumours Br J Cancer 99 1387 1394 1:CAS:528: DC%2BD1cXhtlSktb%2FI 10.1038/sj.bjc.6604723 18971935
11. Tebbutt N, Burris H, Hurwitz H, Stephenson J, Kotasek D, Goldstein D, Sikorski R, Sun Y, McCoy S, Schwartzberg L (2008) Safety and pharmacokinetics (PK) of motesanib diphosphate with or without panitumumab (pmab) plus FOLFIRI or FOLFOX for the treatment of metastatic colorectal cancer (mCRC) [abstract 468PD]. Ann Oncol 19 (suppl): viii155-156
12. SI Sherman LJ Wirth JP Droz M Hofmann L Bastholt RG Martins L Licitra MJ Eschenberg YN Sun T Juan DE Stepan MJ Schlumberger 2008 Motesanib diphosphate in progressive differentiated thyroid cancer N Engl J Med 359 31 42 1:CAS:528:DC%2BD1cXotFSisL8%3D 10.1056/NEJMoa075853 18596272 (Pubitemid 351931094)
13. MJ Schlumberger R Elisei L Bastholt LJ Wirth RG Martins LD Locati B Jarzab F Pacini C Daumerie JP Droz MJ Eschenberg YN Sun T Juan DE Stepan SI Sherman 2009 Phase II study of safety and efficacy of motesanib in patients with progressive or symptomatic, advanced or metastatic medullary thyroid cancer J Clin Oncol 27 3794 3801 1:CAS:528:DC%2BD1MXhtFaitr3F 10.1200/JCO.2008.18.7815 19564535
14. Lu J-F, Claret L, Sutjandra L, Kuchimanchi M, Melara R, Bruno R, Sun Y-N (2010) Population pharmacokinetic/pharmacodynamic modeling for the time course of tumor shrinkage by motesanib in thyroid cancer patients. Cancer Chemother Pharmacol. doi: 10.1007/s00280-010-1456-0 (this issue)
15. P Therasse SG Arbuck EA Eisenhauer J Wanders RS Kaplan L Rubinstein J Verweij M Van Glabbeke AT van Oosterom MC Christian SG Gwyther 2000 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 92 205 216 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10.1093/jnci/92.3.205 10655437
16. Gabrielsson J, Weiner D (2007) Pharmacokinetic and pharmacodynamic data analysis: concepts and applications. Swedish Pharmaceutical Press, Stockholm
17. Beal SL, Sheiner LB (1998) NONMEM user's guide-part VII. Conditional estimation methods. NONMEM project group, University of California, San Francisco
18. WQ Meeker SD Duke 1981 CENSOR-a user oriented computer program for life data analysis Am Stat 35 112 10.2307/2683159
19. Claret L, Stark FS, Sirzen F, Gieschke R, Bruno R (2008) A modeling framework to simulate Xeloda dose intensity and survival in colorectal cancer [abstract 1312]. Presented at: annual meeting of the population approach group in Europe. June 18-20. Marseille, France