O'Shaughnessy JA, Wittes RE, Burke G, Friedman MA, Johnson JR, Niederhuber JE, Rothenberg ML, Woodcock J, Chabner BA, Temple R: Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials. J Clin Oncol. 1991, 9 (12): 2225-2232.
PubMed
Google Scholar
Tsang R, Colley L, Lynd LD: Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials. J Clin Epidemiol. 2009, 62 (6): 609-616. 10.1016/j.jclinepi.2008.08.005.
Article
PubMed
Google Scholar
Pitrou I, Boutron I, Ahmad N, Ravaud P: Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009, 169 (19): 1756-1761.
Article
PubMed
Google Scholar
Ioannidis JP: Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med. 2009, 169 (19): 1737-1739.
Article
PubMed
Google Scholar
Rosen LS, Kurzrock R, Mulay M, Van Vugt A, Purdom M, Ng C, Silverman J, Koutsoukos A, Sun YN, Bass MB, Xu RY, Polverino A, Wiezorek JS, Chang DD, Benjamin R, Herbst RS: Safety, pharmacokinetics, and efficacy of AMG 706, an oral multikinase inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2007, 25 (17): 2369-2376. 10.1200/JCO.2006.07.8170.
Article
CAS
PubMed
Google Scholar
Benjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L: Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011, 68 (1): 69-77. 10.1007/s00280-010-1431-9.
Article
CAS
PubMed
Google Scholar
Sherman SI, Wirth LJ, Droz JP, Hofmann M, Bastholt L, Martins RG, Licitra L, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Schlumberger MJ: Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med. 2008, 359 (1): 31-42. 10.1056/NEJMoa075853.
Article
CAS
PubMed
Google Scholar
Schlumberger MJ, Elisei R, Bastholt L, Wirth LJ, Martins RG, Locati LD, Jarzab B, Pacini F, Daumerie C, Droz JP, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Sherman SI: Phase II study of safety and efficacy of motesanib in patients with progressive or symptomatic, advanced or metastatic medullary thyroid cancer. J Clin Oncol. 2009, 27 (23): 3794-3801. 10.1200/JCO.2008.18.7815.
Article
CAS
PubMed
Google Scholar
Blumenschein GR, Reckamp K, Stephenson GJ, O'Rourke T, Gladish G, McGreivy J, Sun YN, Ye Y, Parson M, Sandler A: Phase 1b study of motesanib, an oral angiogenesis inhibitor, in combination with carboplatin/paclitaxel and/or panitumumab for the treatment of advanced non-small cell lung cancer. Clin Cancer Res. 2010, 16 (1): 279-290. 10.1158/1078-0432.CCR-09-1675.
Article
CAS
PubMed
Google Scholar
Blumenschein GR, Kabbinavar F, Menon H, Mok TS, Stephenson J, Beck JT, Lakshmaiah K, Reckamp K, Hei YJ, Kracht K, Sun YN, Sikorski R, Schwartzberg L, on behalf of the Motesanib NPIISI: 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. 2011, 22 (9): 2057-2067. 10.1093/annonc/mdq731.
Article
PubMed
Google Scholar
Rosen PJ, Sweeney CJ, Park DJ, Beaupre DM, Deng H, Leitch IM, Shubhakar P, Zhu M, Oliner KS, Anderson A, Yee LK: A phase Ib study of AMG 102 in combination with bevacizumab or motesanib in patients with advanced solid tumors. Clin Cancer Res. 2010, 16 (9): 2677-2687. 10.1158/1078-0432.CCR-09-2862.
Article
CAS
PubMed
Google Scholar
Sawaki A, Yamada Y, Komatsu Y, Kanda T, Doi T, Koseki M, Baba H, Sun YN, Murakami K, Nishida T: Phase II study of motesanib in Japanese patients with advanced gastrointestinal stromal tumors with prior exposure to imatinib mesylate. Cancer Chemother Pharmacol. 2010, 65 (5): 961-967. 10.1007/s00280-009-1103-9.
Article
CAS
PubMed
Google Scholar
Fujisaka Y, Yamada Y, Yamamoto N, Shimizu T, Fujiwara Y, Yamada K, Tamura T, Watanabe H, Sun YN, Bass MB, Seki M: Phase 1 study of the investigational, oral angiogenesis inhibitor motesanib in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2010, 66 (5): 935-943. 10.1007/s00280-010-1243-y.
Article
CAS
PubMed
Google Scholar
Price TJ, Lipton L, McGreivy J, McCoy S, Sun YN, Rosenthal MA: Safety and pharmacokinetics of motesanib in combination with gemcitabine for the treatment of patients with solid tumours. Br J Cancer. 2008, 99 (9): 1387-1394. 10.1038/sj.bjc.6604723.
Article
CAS
PubMed
PubMed Central
Google Scholar
LoRusso P, Heath EI, McGreivy J, Sun YN, Melara R, Yan L, Malburg L, Ingram M, Wiezorek J, Chen L, Pilat MJ: Effect of coadministration of ketoconazole, a strong CYP3A4 inhibitor, on pharmacokinetics and tolerability of motesanib diphosphate (AMG 706) in patients with advanced solid tumors. Invest New Drugs. 2008, 26 (5): 455-462. 10.1007/s10637-008-9144-1.
Article
CAS
PubMed
Google Scholar
Burris H, Stephenson J, Otterson GA, Stein M, McGreivy J, Sun YN, Ingram M, Ye Y, Schwartzberg LS: Safety and pharmacokinetics of motesanib in combination with panitumumab and gemcitabine-Cisplatin in patients with advanced cancer. J Oncol. 2011, 2011: 853931-
Article
PubMed
PubMed Central
Google Scholar
Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD: Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006, 295 (21): 2516-2524. 10.1001/jama.295.21.2516.
Article
CAS
PubMed
Google Scholar
de Lima Lopes G, Rocha Lima CM: Emphysematous cholecystitis in a patient with gastrointestinal stromal tumor treated with sunitinib. Pharmacotherapy. 2007, 27 (5): 775-777. 10.1592/phco.27.5.775.
Article
PubMed
Google Scholar
Gomez-Abuin G, Karam AA, Mezzadri NA, Bas CA: Acalculous cholecystitis in a patient with metastatic renal cell carcinoma treated with sunitinib. Clin Genitourin Cancer. 2009, 7 (1): 62-63. 10.3816/CGC.2009.n.011.
Article
PubMed
Google Scholar
Sanda M, Tamai H, Deguchi H, Mori Y, Moribata K, Shingaki N, Ueda K, Inoue I, Maekita T, Iguchi M, Yanaoka K, Oka M, Ichinose M: Acalculous cholecystitis in a patient with hepatocellular carcinoma on sorafenib. ISRN Gastroenterol. 2011, 2011: 201529-
Article
PubMed
Google Scholar
Laurie SA, Gauthier I, Arnold A, Shepherd FA, Ellis PM, Chen E, Goss G, Powers J, Walsh W, Tu D, Robertson J, Puchalski TA, Seymour L: Phase I and pharmacokinetic study of daily oral AZD2171, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with carboplatin and paclitaxel in patients with advanced non-small-cell lung cancer: the National Cancer Institute of Canada clinical trials group. J Clin Oncol. 2008, 26 (11): 1871-1878. 10.1200/JCO.2007.14.4741.
Article
CAS
PubMed
Google Scholar
Batchelor TT, Duda DG, di Tomaso E, Ancukiewicz M, Plotkin SR, Gerstner E, Eichler AF, Drappatz J, Hochberg FH, Benner T, Louis DN, Cohen KS, Chea H, Exarhopoulos A, Loeffler JS, Moses MA, Ivy P, Sorensen AG, Wen PY, Jain RK: Phase II study of cediranib, an oral pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor, in patients with recurrent glioblastoma. J Clin Oncol. 2010, 28 (17): 2817-2823. 10.1200/JCO.2009.26.3988.
Article
CAS
PubMed
PubMed Central
Google Scholar
Yeh CN, Chen TW, Liu FY, Jan YY, Chen MF: Genetic changes in advanced gastrointestinal stromal tumor (GIST) patients during imatinib mesylate treatment. Langenbecks Arch Surg. 2006, 391 (6): 615-621. 10.1007/s00423-006-0103-z.
Article
PubMed
Google Scholar
Grant S, Karp JE, Koc ON, Cooper B, Luger S, Figg WD, Egorin M, Druker BJ, Jacobberger JW, Ramakrishnan V, Perkins EB, Colevas AD, Roberts JD: Phase I study of flavopiridol in combination with imatinib mesylate (ST1571, Gleevec) in Bcr/Abl + hematological malignancies [abstract]. Blood. 2005, 106: 1102-
Google Scholar
Nexavar® (sorafenib) Full Prescribing Information. Edited by: Wayne NJ. 2011, Bayer Healthcare Pharmaceuticals, Inc, http://berlex.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf]
Google Scholar
European Medicines Agency: Nexavar European Public Assessment Report, Summary of Product Characteristics. 2011, London, UK: European Medicines Agency, [http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000690/WC500027704.pdf]
Google Scholar
Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG: 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 (3): 205-216. 10.1093/jnci/92.3.205.
Article
CAS
PubMed
Google Scholar
Kotasek D, Tebbutt N, Desai J, Welch S, Siu LL, McCoy S, Sun YN, Johnson J, Adewoye AH, Price T: Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study. BMC Cancer. 2011, 11: 313-10.1186/1471-2407-11-313.
Article
CAS
PubMed
PubMed Central
Google Scholar
Burstein HJ, Elias AD, Rugo HS, Cobleigh MA, Wolff AC, Eisenberg PD, Lehman M, Adams BJ, Bello CL, DePrimo SE, Baum CM, Miller KD: Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2008, 26 (11): 1810-1816. 10.1200/JCO.2007.14.5375.
Article
CAS
PubMed
Google Scholar
Drevs J, Siegert P, Medinger M, Mross K, Strecker R, Zirrgiebel U, Harder J, Blum H, Robertson J, Jurgensmeier JM, Puchalski TA, Young H, Saunders O, Unger C: Phase I clinical study of AZD2171, an oral vascular endothelial growth factor signaling inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2007, 25 (21): 3045-3054. 10.1200/JCO.2006.07.2066.
Article
CAS
PubMed
Google Scholar
Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM: Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009, 27 (20): 3312-3318. 10.1200/JCO.2008.19.5511.
Article
CAS
PubMed
Google Scholar
Gibbons J, Egorin MJ, Ramanathan RK, Fu P, Mulkerin DL, Shibata S, Takimoto CH, Mani S, LoRusso PA, Grem JL, Pavlick A, Lenz HJ, Flick SM, Reynolds S, Lagattuta TF, Parise RA, Wang Y, Murgo AJ, Ivy SP, Remick SC: Phase I and pharmacokinetic study of imatinib mesylate in patients with advanced malignancies and varying degrees of renal dysfunction: a study by the National Cancer Institute Organ Dysfunction Working Group. J Clin Oncol. 2008, 26 (4): 570-576. 10.1200/JCO.2007.13.3819.
Article
CAS
PubMed
Google Scholar
Hotte SJ, Winquist EW, Lamont E, MacKenzie M, Vokes E, Chen EX, Brown S, Pond GR, Murgo A, Siu LL: Imatinib mesylate in patients with adenoid cystic cancers of the salivary glands expressing c-kit: a Princess Margaret Hospital phase II consortium study. J Clin Oncol. 2005, 23 (3): 585-590.
Article
CAS
PubMed
Google Scholar
Matulonis UA, Berlin S, Ivy P, Tyburski K, Krasner C, Zarwan C, Berkenblit A, Campos S, Horowitz N, Cannistra SA, Lee H, Lee J, Roche M, Hill M, Whalen C, Sullivan L, Tran C, Humphreys BD, Penson RT: Cediranib, an oral inhibitor of vascular endothelial growth factor receptor kinases, is an active drug in recurrent epithelial ovarian, fallopian tube, and peritoneal cancer. J Clin Oncol. 2009, 27 (33): 5601-5606. 10.1200/JCO.2009.23.2777.
Article
CAS
PubMed
PubMed Central
Google Scholar
Moreno-Aspitia A, Morton RF, Hillman DW, Lingle WL, Rowland KM, Wiesenfeld M, Flynn PJ, Fitch TR, Perez EA: Phase II trial of sorafenib in patients with metastatic breast cancer previously exposed to anthracyclines or taxanes: North Central Cancer Treatment Group and Mayo Clinic Trial N0336. J Clin Oncol. 2009, 27 (1): 11-15.
Article
CAS
PubMed
Google Scholar
Sweeney CJ, Chiorean EG, Verschraegen CF, Lee FC, Jones S, Royce M, Tye L, Liau KF, Bello A, Chao R, Burris HA: A phase I study of sunitinib plus capecitabine in patients with advanced solid tumors. J Clin Oncol. 2010, 28 (29): 4513-4520. 10.1200/JCO.2009.26.9696.
Article
CAS
PubMed
PubMed Central
Google Scholar
Breccia M, D'Andrea M, Alimena G: Can nifedipine and estrogen interaction with imatinib be responsible for gallbladder stone development?. Eur J Haematol. 2005, 75 (1): 89-90. 10.1111/j.1600-0609.2005.00476.x.
Article
PubMed
Google Scholar
Li C, Kuchimanchi M, Hickman D, Poppe L, Hayashi M, Zhou Y, Subramanian R, Kumar G, Surapaneni S: In vitro metabolism of the novel, highly selective oral angiogenesis inhibitor motesanib diphosphate in preclinical species and in humans. Drug Metab Dispos. 2009, 37 (7): 1378-1394. 10.1124/dmd.108.025742.
Article
CAS
PubMed
Google Scholar
Loreno M, Travali S, Bucceri AM, Scalisi G, Virgilio C, Brogna A: Ultrasonographic study of gallbladder wall thickness and emptying in cirrhotic patients without gallstones. Gastroenterol Res Pract. 2009, 2009: 683040-
Article
PubMed
PubMed Central
Google Scholar
Krishnamurthy GT, Krishnamurthy S, Brown PH: Constancy and variability of gallbladder ejection fraction: impact on diagnosis and therapy. J Nucl Med. 2004, 45 (11): 1872-1877.
PubMed
Google Scholar
Elwood DR: Cholecystitis. Surg Clin North Am. 2008, 88 (6): 1241-1252. 10.1016/j.suc.2008.07.008.
Article
PubMed
Google Scholar