Exposure-response (safety) analysis to identify linifanib dose for a phase III study in patients with hepatocellular carcinoma

Clinical Therapeutics

Volumn 35, Issue 11, 2013, Pages 1770-1777

  Chiu, Yi Lin ^a   Carlson, Dawn M ^a   Pradhan, Rajendra S ^a,b   Ricker, Justin L ^a  

^a ABBVIE INC   (United States)

^b ALEXION PHARMACEUTICALS   (United States)

Author keywords

HCC; linifanib; PDGF; VEGF

Indexed keywords

LINIFANIB; PLATELET DERIVED GROWTH FACTOR; PLATELET DERIVED GROWTH FACTOR RECEPTOR; VASCULOTROPIN; VASCULOTROPIN RECEPTOR;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BODY WEIGHT; CANCER CHEMOTHERAPY; DIARRHEA; DRUG FORMULATION; DRUG SAFETY; DRUG SELECTIVITY; DRUG TARGETING; FEMALE; HUMAN; HYPERTENSION; LIVER CELL CARCINOMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROTEINURIA; RACE DIFFERENCE; REPEATED DRUG DOSE; SEX DIFFERENCE; SINGLE DRUG DOSE; SOLID TUMOR;

HCC; LINIFANIB; PDGF; VEGF;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INDAZOLES; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASMS; PHARMACEUTICAL SOLUTIONS; PHENYLUREA COMPOUNDS; TABLETS; YOUNG ADULT;

EID: 84888001200     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2013.09.002     Document Type: Article

References (14)

1. J.M. Llovet, A.M. Di Bisceglie, and J. Bruix Design and endpoints of clinical trials in hepatocellular carcinoma J Natl Cancer Inst 100 2008 698 711
2. H.B. El-Serag Hepatocellular carcinoma N Engl J Med 365 2011 1118 1127
3. K.A. McGlynn, and W.T. London Epidemiology and natural history of hepatocellular carcinoma Best Prac Res Clin Gastroenterol 19 2005 3 23
4. Y. Dai, K. Hartandi, and Z. Ji Discovery of N-(4-(3-amino-1H-indazol-4- yl)phenyl)-N'-(2-fluoro-5-methylphenyl)urea (ABT-869), a 3-aminoindazole-based orally active multitargeted receptor tyrosine kinase inhibitor J Med Chem 50 2007 1584 1597
5. D.H. Albert, P. Tapang, and T.J. Magoc Preclinical activity of ABT-869, a multitargeted receptor tyrosine kinase inhibitor Mol Cancer Ther 5 2006 995 1006
6. J. Guo, P.A. Marcotte, and J.O. McCall Inhibition of phosphorylation of the colony-stimulating factor-1 receptor (c-Fms) tyrosine kinase in transfected cells by ABT-869 and other tyrosine kinase inhibitors Mol Cancer Ther 5 2006 1007 1013
7. Donawho C, Bukofzer G, Palma J, et al. The RTK inhibitor, ABT-869 alone or in combination with various cytotoxic therapies demonstrate significant tumor growth inhibition in orthotopic hepatocellular carcinoma, renal cell carcinoma and prostate xenografts. Abstract and poster presented at: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; October 22-26, 2007; San Francisco, Calif.
8. V.J. Jasinghe, Z. Xie, and J. Zhou ABT-869, a multi-targeted tyrosine kinase inhibitor, in combination with rapamycin is effective for subcutaneous hepatocellular carcinoma xenograft J Hepatol 49 2008 985 997
9. C.I. Wong, T.S. Koh, and R. Soo Phase I and biomarker study of ABT-869, a multiple receptor tyrosine kinase inhibitor, in patients with refractory solid malignancies J Clin Oncol 27 2009 4718 4726
10. E.H. Tan, G.D. Goss, and R. Salgia Phase 2 trial of linifanib (ABT-869) in patients with advanced non-small cell lung cancer J Thorac Oncol 6 2011 1418 1425
11. N.M. Tannir, Y.N. Wong, and C.K. Kollmannsberger Phase 2 trial of linifanib (ABT-869) in patients with advanced renal cell cancer after sunitinib failure Eur J Cancer 47 2011 2706 2714
12. H.C. Toh, P.J. Chen, and B.I. Carr Phase 2 trial of linifanib (ABT-869) in patients with unresectable or metastatic hepatocellular carcinoma Cancer 119 2012 380 387
13. Beal SL, Sheiner LB, Boeckmann AJ, eds. NONMEM Users Guide (1989-2008). Ellicott City, Md: Icon Development Solutions; 1989-2006
14. National Cancer Institute. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). 2006. http://ctep.cancer.gov/protocolDevelopment/electronic- applications/docs/ctcaev3.pdf. Accessed October 12, 2012.