A phase 1 study of linifanib in combination with carboplatin/paclitaxel as first-line treatment of Japanese patients with advanced or metastatic non-small cell lung cancer (NSCLC)

Cancer Chemotherapy and Pharmacology

Volumn 74, Issue 1, 2014, Pages 37-43

  Horinouchi, Hidehito ^a   Yamamoto, Noboru ^a   Nokihara, Hiroshi ^a   Horai, Takeshi ^b   Nishio, Makoto ^b   Ohyanagi, Fumiyoshi ^b   Horiike, Atsushi ^b   Nakagawa, Kazuhiko ^c   Terashima, Masaaki ^c   Okabe, Takafumi ^c   Kaneda, Hiroyasu ^c   McKee, Mark D ^d   Carlson, Dawn M ^d   Xiong, Hao ^d   Tamura, Tomohide ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b CANCER INSTITUTE HOSPITAL   (Japan)

^c KINKI UNIVERSITY   (Japan)

^d ABBVIE INC   (United States)

Author keywords

Angiogenesis; Linifanib (ABT 869); NSCLC; PDGFR; VEGFR

Indexed keywords

CARBOPLATIN; LINIFANIB; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CHEMOTHERAPY INDUCED ANEMIA; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG EXPOSURE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOPHOSPHATEMIA; JAPANESE (PEOPLE); LEUKOPENIA; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT WITHDRAWAL;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA; CARCINOMA, NON-SMALL-CELL LUNG; CHEMOTHERAPY-INDUCED FEBRILE NEUTROPENIA; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INDAZOLES; JAPAN; LEUKOPENIA; LUNG; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; PHENYLUREA COMPOUNDS; PROTEIN KINASE INHIBITORS; RECEPTORS, PLATELET-DERIVED GROWTH FACTOR; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; SEVERITY OF ILLNESS INDEX; THROMBOCYTOPENIA; TUMOR BURDEN;

EID: 84903816615     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-014-2478-9     Document Type: Article

References (18)

1. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346(2):92-98 (Pubitemid 34438899)
2. Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, Ou SH, Dezube BJ, Janne PA, Costa DB, Varella-Garcia M, Kim WH, Lynch TJ, Fidias P, Stubbs H, Engelman JA, Sequist LV, Tan W, Gandhi L, Mino-Kenudson M, Wei GC, Shreeve SM, Ratain MJ, Settleman J, Christensen JG, Haber DA, Wilner K, Salgia R, Shapiro GI, Clark JW, Iafrate AJ (2010) Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 363(18):1693-1703
3. Camidge DR, Bang YJ, Kwak EL, Iafrate AJ, Varella-Garcia M, Fox SB, Riely GJ, Solomon B, Ou SH, Kim DW, Salgia R, Fidias P, Engelman JA, Gandhi L, Janne PA, Costa DB, Shapiro GI, Lorusso P, Ruffner K, Stephenson P, Tang Y, Wilner K, Clark JW, Shaw AT (2012) Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol 13(10):1011-1019
4. Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Ogura T, Ando M, Miyazawa H, Tanaka T, Saijo Y, Hagiwara K, Morita S, Nukiwa T (2010) Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 362(25):2380-2388
5. Mitsudomi T, Morita S, Yatabe Y, Negoro S, Okamoto I, Tsurutani J, Seto T, Satouchi M, Tada H, Hirashima T, Asami K, Katakami N, Takada M, Yoshioka H, Shibata K, Kudoh S, Shimizu E, Saito H, Toyooka S, Nakagawa K, Fukuoka M (2010) Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 11(2):121-128
6. Herbst RS, Onn A, Sandler A (2005) Angiogenesis and lung cancer: prognostic and therapeutic implications. J Clin Oncol 23(14):3243-3256 (Pubitemid 46211349)
7. Herbst RS, Heymach JV, Lippman SM (2008) Lung cancer. N Engl J Med 359(13):1367-1380
8. O'Byrne KJ, Koukourakis MI, Giatromanolaki A, Cox G, Turley H, Steward WP, Gatter K, Harris AL (2000) Vascular endothelial growth factor, platelet-derived endothelial cell growth factor and angiogenesis in non-small-cell lung cancer. Br J Cancer 82(8):1427-1432. doi:10.1054/bjoc.1999. 1129 (Pubitemid 30175909)
9. Giaccone G (2007) The potential of antiangiogenic therapy in non-small cell lung cancer. Clin Cancer Res 13(7):1961-1970
10. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH (2006) Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355(24):2542-2550 (Pubitemid 44917502)
11. Zhou J, Goh B-C, Albert D, Chen C-S (2009) ABT-869, a promising multi-targeted tyrosine kinase inhibitor: from bench to bedside. J Hematol Oncol 2:33
12. Albert DH, Tapang P, Magoc TJ, Pease LJ, Reuter DR, Wei RQ, Li J, Guo J, Bousquet PF, Ghoreishi-Haack NS, Wang B, Bukofzer GT, Wang YC, Stavropoulos JA, Hartandi K, Niquette AL, Soni N, Johnson EF, McCall JO, Bouska JJ, Luo Y, Donawho CK, Dai Y, Marcotte PA, Glaser KB, Michaelides MR, Davidsen SK (2006) Preclinical activity of ABT-869, a multitargeted receptor tyrosine kinase inhibitor. Mol Cancer Ther 5(4):995-1006 (Pubitemid 43724600)
13. Albert DH, Reuter D, Ellis PA, Bukofzer G, Donawho CK, McKee MD, Ricker JL, Carlson DM, Davidsen SK (2011) Efficacy of linifanib in preclinical models of NSCLC with wild-type and mutated KRAS. Proc World Conf Lung Cancer 2011:Abstract M011.013
14. Wong CI, Koh TS, Soo R, Hartono S, Thng CH, McKeegan E, Yong WP, Chen CS, Lee SC, Wong J, Lim R, Sukri N, Lim SE, Ong AB, Steinberg J, Gupta N, Pradhan R, Humerickhouse R, Goh BC (2009) Phase I and biomarker study of ABT-869, a multiple receptor tyrosine kinase inhibitor, in patients with refractory solid malignancies. J Clin Oncol 27(28):4718-4726
15. Liu L, Wu C, Wang Y, Zhong R, Duan S, Wei S, Lin S, Zhang X, Tan W, Yu D, Nie S, Miao X, Lin D (2011) Combined effect of genetic polymorphisms in P53, P73, and MDM2 on non-small cell lung cancer survival. J Thorac Oncol 6(11):1793-1800. doi:10.1097/JTO.0b013e3182272273
16. Asahina H, Tamura Y, Nokihara H, Yamamoto N, Seki Y, Shibata T, Goto Y, Tanioka M, Yamada Y, Coates A, Chiu YL, Li X, Pradhan R, Ansell PJ, McKeegan EM, McKee MD, Carlson DM, Tamura T (2012) An open-label, phase 1 study evaluating safety, tolerability, and pharmacokinetics of linifanib (ABT-869) in Japanese patients with solid tumors. Cancer Chemother Pharmacol 69(6):1477-1486
17. Ramalingam S, Shtivelband M, Soo R, Barrios CH, Makhson A, Segalla J, Pitman K, Kolman P, Rodrigues J, Srkalovic G, Belani C, Axelrod R, Owonikoko T, Qian J, McKee M, Ricker J, Carlson DM, Gorbunova V (2012) Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced squamous NSCLC. J Clin Oncol 30(suppl):abstr 7512
18. Gupta N, Palaparthy R, Awni W, Carlson D, Pradhan R (2009) Carboplatin/paclitaxel in combination with linifanib (ABT-869) versus carboplatin/paclitaxel alone in patients with advanced or metastatic non-small cell lung cancer (NSCLC) as first-line treatment. J Thorac Oncol 4(9, S1):S669