Phase 2 trial of linifanib (ABT-869) in patients with advanced renal cell cancer after sunitinib failure

European Journal of Cancer

Volumn 47, Issue 18, 2011, Pages 2706-2714

  Tannir, Nizar M ^a   Wong, Yu Ning ^b   Kollmannsberger, Christian K ^c   Ernstoff, Marc S ^d   Perry, David J ^e   Appleman, Leonard J ^f   Posadas, Edwin M ^g   Cho, Daniel ^h   Choueiri, Toni K ⁱ   Coates, Andrew ^j   Gupta, Neeraj ^j   Pradhan, Rajendra ^j   Qian, Jiang ^j   Chen, Jihong ^j   Scappaticci, Frank A ^k   Ricker, Justin L ^j   Carlson, Dawn M ^j   Dror Michaelson, M ^l  

^a UNIVERSITY OF TEXAS   (United States)

^b FOX CHASE CANCER CENTER   (United States)

^c BRITISH COLUMBIA CANCER AGENCY   (Canada)

^d DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^e WASHINGTON CANCER INSTITUTE   (United States)

^f UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^g CEDARS SINAI MEDICAL CENTER   (United States)

^h BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

ⁱ DANA FARBER CANCER INSTITUTE   (United States)

^j ABBOTT LABORATORIES   (United States)

^k GENENTECH INC   (United States)

^l MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

more..

Author keywords

ABT 869; Angiogenesis inhibitors; Renal cell carcinoma; Sunitinib; VEGFR

Indexed keywords

ATRASENTAN; BEVACIZUMAB; ERLOTINIB; GEMCITABINE; LINIFANIB; SUNITINIB; TEMSIROLIMUS; VACCINE; ZOLEDRONIC ACID;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; ANEMIA; APPETITE; ARTICLE; CANCER GROWTH; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEART INFARCTION; HEMOPTYSIS; HISTOLOGY; HUMAN; HYPERTENSION; KIDNEY CANCER; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEPHRECTOMY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RISK ASSESSMENT; SIDE EFFECT; SOLID TUMOR; TREATMENT FAILURE; TREATMENT RESPONSE; VOMITING; WEIGHT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; FEMALE; HUMANS; INDAZOLES; INDOLES; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; PHENYLUREA COMPOUNDS; PYRROLES; TREATMENT FAILURE;

EID: 82255160698     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2011.09.002     Document Type: Article

References (37)

1. A. Mohammed, I. Shergill, and B. Little Management of metastatic renal cell carcinoma: current trends Expert Rev Mol Diagn 9 2009 75 83
2. R.J. Motzer, and A.M. Molina Targeting renal cell carcinoma J Clin Oncol 27 2009 3274 3276
3. J.M.G. Larkin, E.L.S. Kipps, C.J. Powell, and C. Swanton Review: systemic therapy for advanced renal cell carcinoma Ther Adv Med Oncol 1 2009 15 27
4. G. Bergers, S. Song, N. Meyer-Morse, E. Bergsland, and D. Hanahan Benefits of targeting both pericytes and endothelial cells in the tumor vasculature with kinase inhibitors J Clin Invest 111 2003 1287 1295 (Pubitemid 36554699)
5. R. Erber, A. Thurnher, and A.D. Katsen Combined inhibition of VEGF and PDGF signaling enforces tumor vessel regression by interfering with pericyte-mediated endothelial cell survival mechanisms FASEB J 18 2004 338 340
6. K. Pietras, and D. Hanahan A multitargeted, metronomic, and maximum-tolerated dose 'chemo-switch' regimen is antiangiogenic, producing objective responses and survival benefit in a mouse model of cancer J Clin Oncol 23 2005 939 952 (Pubitemid 46202314)
7. J.S. Lam, O. Shvarts, J.T. Leppert, R.A. Figlin, and A.S. Belldegrun Renal cell carcinoma 2005: new frontiers in staging, prognostication and targeted molecular therapy J Urol 173 2005 1853 1862 (Pubitemid 40675199)
8. Bayer Healthcare Pharmaceuticals, Inc., Sorafenib [package insert]. Emeryville, CA. 2009. http://berlex.bayerhealthcare.com/html/products/pi/ Nexavar-PI.pdf.
9. Pfizer Labs. Sunitinib [package insert]. New York, NY. 2008. http://labeling.pfizer.com/ShowLabeling.aspx?id=607.
10. GlaxoSmithKline. Pazopanib [package insert]. Research Triangle Park, NC. 2009. http://us.gsk.com/products/assets/us-votrient.pdf.
11. B. Escudier, A. Pluzanska, and P. Koralewski Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial Lancet 370 2007 2103 2111 (Pubitemid 350296300)
12. G. Hudes, M. Carducci, and P. Tomczak Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma N Engl J Med 356 2007 2271 2281 (Pubitemid 46849157)
13. Wyeth Pharmaceuticals, Inc., Temsirolimus [package insert]. Philadelphia, PA. 2008. http://www.wyeth.com/content/showlabeling.asp?id=490.
14. B.I. Rini, M.D. Michaelson, and J.E. Rosenberg Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma J Clin Oncol 26 2008 3743 3748
15. D.R. Shepard, B.I. Rini, and J.A. Garcia A multicenter prospective trial of sorafenib in patients (pts) with metastatic clear cell renal cell carcinoma (mccRCC) refractory to prior sunitinib or bevacizumab J Clin Oncol (Meeting Abstracts) 26 2008 (abstract 5123)
16. G. Di Lorenzo, G. Carteni, and R. Autorino Phase II study of sorafenib in patients with sunitinib-refractory metastatic renal cell cancer J Clin Oncol 27 2009 4469 4474
17. B.I. Rini, G. Wilding, and G. Hudes Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma J Clin Oncol 27 2009 4462 4468
18. Novartis Pharma Stein AG. Everolimus [package insert]. Stein, Switzerland. 2009. http://www.pharma.us.novartis.com/product/pi/pdf/afinitor. pdf.
19. National Institutes of Health: A randomized trial of temsirolimus versus sorafenib as second-line therapy in patients with advanced renal cell carcinoma who have failed first-line sunitinib therapy. Protocol: (NCT00474786). http://www.clinicaltrials.gov/.
20. National Institutes of Health: Axitinib (AG 013736) As second line therapy for metastatic renal cell cancer: Axis trial. Protocols: (NCT00678392). http://www.clinicaltrials.gov/.
21. B.I. Rini, B. Escudier, and P. Tomczak Axitinib versus sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC): results of phase III AXIS trial J Clin Oncol (Meeting Abstracts) 29 2011 (abstract 4503)
22. 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 (Pubitemid 43724600)
23. 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
24. National Institutes of Health: An open-label, phase 2 study to evaluate the efficacy and tolerability of ABT-869 in subjects with advanced renal cell carcinoma (RCC) who have previously received treatment with sunitinib. Protocol: (NCT00486538). http://www.clinicaltrials.gov/.
25. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer New guidelines to evaluate the response to treatment in solid tumors J Natl Cancer Inst 92 2000 205 216 (Pubitemid 30099779)
26. J.P. O'Connor, A. Jackson, G.J. Parker, and G.C. Jayson DCE-MRI biomarkers in the clinical evaluation of antiangiogenic and vascular disrupting agents Br J Cancer 96 2007 189 195 (Pubitemid 46160619)
27. J.A. Thie Understanding the standardized uptake value, its methods, and implications for usage J Nucl Med 45 2004 1431 1434 (Pubitemid 47618494)
28. R.J. Motzer, J. Bacik, and L.H. Schwartz Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma J Clin Oncol 22 2004 454 463 (Pubitemid 41079774)
29. J.M. Bland, and D.G. Altman Survival probabilities (the Kaplan-Meier method) BMJ 317 1998 1572 (Pubitemid 128719735)
30. NCI. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). 2006. http://ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ctcaev3. pdf.
31. L. Shargel, S. Wu-Pong, and A.B. Yu Applied Biopharmaceutics and Pharmacokinetics 4th ed. 2005 McGraw-Hill
32. U. Wählby, E. Jonsson, and M. Karlsson Comparison of stepwise covariate model building strategies in population pharmacokinetic- pharmacodynamic analysis AAPS PharmSci 4 2002 E27
33. R.J. Motzer, T.E. Hutson, and P. Tomczak Sunitinib versus interferon alfa in metastatic renal-cell carcinoma N Engl J Med 356 2007 115 124 (Pubitemid 46089672)
34. R.J. Motzer, B. Escudier, and S. Oudard Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial Lancet 372 2008 449 456
35. H. Izzedine, C. Massard, and J.P. Spano VEGF signalling inhibition-induced proteinuria: mechanisms, significance and management Eur J Cancer 46 2010 439 448
36. National Institutes of Health: Efficacy and tolerability of ABT-869 versus sorafenib in advanced hepatocellular carcinoma (HCC). Protocol: (NCT01009593). http://www.clinicaltrials.gov/.
37. E.M. Posadas, N.M. Tannir, and Y. Wong Phase II trial of linifanib in patients (pts) with advanced renal cell carcinoma (RCC): Analysis of pts receiving extended therapy J Clin Oncol (Meeting Abstracts) 29 2011 (abstract 2543)