Simulations using a drugdisease modeling framework and phase ii data predict phase iii survival outcome in first-line nonsmall-cell lung cancer

Clinical Pharmacology and Therapeutics

Volumn 92, Issue 5, 2012, Pages 631-634

  Claret, L ^a   Lu, J F ^b,c   Bruno, R ^a   Hsu, C P ^b   Hei, Y J ^b   Sun, Y N ^b  

^a A Certara Company   (France)

^b AMGEN INC   (United States)

^c Quantitative Solutions   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; CARBOPLATIN; MOTESANIB; PACLITAXEL; PLACEBO; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; IMETELSTAT; INDOLE DERIVATIVE; MONOCLONAL ANTIBODY; NICOTINAMIDE;

ADVANCED CANCER; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE MODEL; HAZARD RATIO; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; SIMULATION; SURVIVAL; BIOLOGICAL MODEL; CLINICAL TRIAL; COMPARATIVE STUDY; COMPUTER SIMULATION; LUNG TUMOR; PATHOLOGY; PHASE 2 CLINICAL TRIAL; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; COMPUTER SIMULATION; HUMANS; INDOLES; LUNG NEOPLASMS; MODELS, BIOLOGICAL; NIACINAMIDE; PACLITAXEL; PROPORTIONAL HAZARDS MODELS; SURVIVAL RATE;

EID: 84867879434     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2012.78     Document Type: Article

References (11)

1. Claret, L. et al. Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent [abstr.]. J. Clin. Oncol. 24, 6025 (2006).
2. Claret, L. et al. 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 (2009).
3. Claret, L., Lu, J-F., Sun, Y-N. & Bruno, R. Development of a modeling framework to simulate efficacy endpoints for motesanib in patients with thyroid cancer. Cancer Chemother. Pharmacol. 66, 1141-1149 (2010).
4. Maitland, M.L., Bies, R.R. & Barrett, J.S. A time to keep and a time to cast away categories of tumor response. J. Clin. Oncol. 29, 3109-3111 (2011).
5. Wang, Y. et al. 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 (2009).
6. Polverino, A. et al. 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 (2006). (Pubitemid 44449188)
7. Rosen, L.S. et al. Safety, pharmacokinetics, and efficacy of AMG 706, an oral multikinase inhibitor, in patients with advanced solid tumors. J. Clin. Oncol. 25, 2369-2376 (2007). (Pubitemid 46999207)
8. Blumenschein, G.R. Jr et al.; Motesanib NSCLC Phase II Study Investigators. A phase II, multicenter, open-label randomized study of motesanib or bevacizumab in combination with paclitaxel and carboplatin for advanced nonsquamous non-small-cell lung cancer. Ann. Oncol. 22, 2057-2067 (2011).
9. Sandler, A. et al. Paclitaxel-carboplatin alone or with bevacizumab for nonsmall-cell lung cancer. N. Engl. J. Med. 355, 2542-2550 (2006). (Pubitemid 44917502)
10. Scagliotti, G. et al. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. J. Clin. Oncol. 29, (2012) [doi: 10.1200/JCO.2011.41.4987].
11. Therasse, P. 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. 92, 205-216 (2000).