Tolerability and pharmacokinetic profile of a sunitinib powder formulation in pediatric patients with refractory solid tumors: A Children's Oncology Group study

Cancer Chemotherapy and Pharmacology

Volumn 69, Issue 4, 2012, Pages 1021-1027

  DuBois, Steven G ^a   Shusterman, Suzanne ^b   Reid, Joel M ^c   Ingle, Ashish M ^d   Ahern, Charlotte H ^e   Baruchel, Sylvain ^f   Glade Bender, Julia ^g   Ivy, Percy ^h   Adamson, Peter C ⁱ   Blaney, Susan M ^e  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b BOSTON CHILDREN S HOSPITAL   (United States)

^c Mayo Clinic College of Medicine   (United States)

^d CHILDREN S ONCOLOGY GROUP   (United States)

^e BAYLOR COLLEGE OF MEDICINE   (United States)

^f HOSPITAL FOR SICK CHILDREN   (Canada)

^g New York Presbyterian Columbia University Medical Center   (United States)

^h NATIONAL CANCER INSTITUTE   (United States)

ⁱ UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Formulation; Pediatric; Pharmacokinetics; Sunitinib

Indexed keywords

N DEETHYLSUNITINIB; SUNITINIB;

ABDOMINAL PAIN; ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BLEEDING; BLOOD TOXICITY; CHEMOTHERAPY INDUCED EMESIS; CHILD; CHILDHOOD CANCER; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; EPENDYMOMA; EPISTAXIS; FATIGUE; FEMALE; GLIOMA; HAND FOOT SYNDROME; HEADACHE; HUMAN; HYPERMAGNESEMIA; HYPERTENSION; HYPOCALCEMIA; HYPOXIA; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MESOTHELIOMA; MOOD DISORDER; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; POWDER; PRESCHOOL CHILD; PRIORITY JOURNAL; PROTEINURIA; SIDE EFFECT; SOLID TUMOR; TASTE DISORDER; THROMBOCYTOPENIA; THYROTROPIN BLOOD LEVEL; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; UNDIFFERENTIATED CARCINOMA;

ADOLESCENT; ANTINEOPLASTIC AGENTS; CHILD; CHILD, PRESCHOOL; HUMANS; INDOLES; NEOPLASMS; POWDERS; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; PYRROLES; YOUNG ADULT;

EID: 84859801305     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-011-1798-2     Document Type: Article

References (18)

1. Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM (2003) SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol Cancer Ther 2:471-478
2. Mendel DB, Laird AD, Xin X, Louie SG, Christensen JG, Li G, Schreck RE, Abrams TJ, Ngai TJ, Lee LB, Murray LJ, Carver J, Chan E, Moss KG, Haznedar JO, Sukbuntherng J, Blake RA, Sun L, Tang C, Miller T, Shirazian S, McMahon G, Cherrington JM (2003) In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship. Clin Cancer Res 9:327-337 (Pubitemid 36109749)
3. O'Farrell AM, Abrams TJ, Yuen HA, Ngai TJ, Louie SG, Yee KW, Wong LM, Hong W, Lee LB, Town A, Smolich BD, Manning WC, Murray LJ, Heinrich MC, Cherrington JM (2003) SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo. Blood 101:3597-3605 (Pubitemid 36857948)
4. Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG (2006) Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet 368:1329-1338 (Pubitemid 44528723)
5. Goodman VL, Rock EP, Dagher R, Ramchandani RP, Abraham S, Gobburu JV, Booth BP, Verbois SL, Morse DE, Liang CY, Chidambaram N, Jiang JX, Tang S, Mahjoob K, Justice R, Pazdur R (2007) Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. Clin Cancer Res 13:1367-1373 (Pubitemid 46450424)
6. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA (2007) Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 356:115-124 (Pubitemid 46089672)
7. Faivre S, Delbaldo C, Vera K, Robert C, Lozahic S, Lassau N, Bello C, Deprimo S, Brega N, Massimini G, Armand JP, Scigalla P, Raymond E (2006) Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 24:25-35 (Pubitemid 46630490)
8. Britten CD, Kabbinavar F, Hecht JR, Bello CL, Li J, Baum C, Slamon D (2008) A phase I and pharmacokinetic study of sunitinib administered daily for 2 weeks, followed by a 1-week off period. Cancer Chemother Pharmacol 61:515-524 (Pubitemid 350275988)
9. Houk BE, Bello CL, Kang D, Amantea M (2009) A population pharmacokinetic meta-analysis of sunitinib malate (SU11248) and its primary metabolite (SU12662) in healthy volunteers and oncology patients. Clin Cancer Res 15:2497-2506
10. DuBois SG, Shusterman S, Ingle AM, Ahern CH, Reid JM, Wu B, Baruchel S, Glade-Bender J, Ivy SP, Grier HE, Adamson PC, Blaney SM (2011) Phase I and Pharmacokinetic Study of Sunitinib in Pediatric Patients with Refractory Solid Tumors: A Children's Oncology Group Study. Clin Cancer Res 17:5113-5122
11. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) 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
12. Bello CL, Sherman L, Zhou J, Verkh L, Smeraglia J, Mount J, Klamerus KJ (2006) Effect of food on the pharmacokinetics of sunitinib malate (SU11248), a multi-targeted receptor tyrosine kinase inhibitor: results from a phase I study in healthy subjects. Anticancer Drugs 17:353-358
13. Navid F, Christensen R, Minkin P, Stewart CF, Furman WL, Baker S (2008) Stability of sunitinib in oral suspension. Ann Pharmacother 42:962-966
14. Sistla A, Sunga A, Phung K, Koparkar A, Shenoy N (2004) Powder-in-bottle formulation of SU011248. Enabling rapid progression into human clinical trials. Drug Dev Ind Pharm 30:19-25 (Pubitemid 38240472)
15. Janeway KA, Albritton KH, Van Den Abbeele AD, D'Amato GZ, Pedrazzoli P, Siena S, Picus J, Butrynski JE, Schlemmer M, Heinrich MC, Demetri GD (2009) Sunitinib treatment in pediatric patients with advanced GIST following failure of imatinib. Pediatr Blood Cancer 52:767-771
16. Norden-Zfoni A, Desai J, Manola J, Beaudry P, Force J, Maki R, Folkman J, Bello C, Baum C, DePrimo SE, Shalinsky DR, Demetri GD, Heymach JV (2007) Blood-based biomarkers of SU11248 activity and clinical outcome in patients with metastatic imatinib-resistant gastrointestinal stromal tumor. Clin Cancer Res 13:2643-2650 (Pubitemid 46788031)
17. Rini BI, Michaelson MD, Rosenberg JE, Bukowski RM, Sosman JA, Stadler WM, Hutson TE, Margolin K, Harmon CS, DePrimo SE, Kim ST, Chen I, George DJ (2008) Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma. J Clin Oncol 26:3743-3748
18. Zhu AX, Sahani DV, Duda DG, di Tomaso E, Ancukiewicz M, Catalano OA, Sindhwani V, Blaszkowsky LS, Yoon SS, Lahdenranta J, Bhargava P, Meyerhardt J, Clark JW, Kwak EL, Hezel AF, Miksad R, Abrams TA, Enzinger PC, Fuchs CS, Ryan DP, Jain RK (2009) Efficacy, safety, and potential biomarkers of sunitinib monotherapy in advanced hepatocellular carcinoma: a phase II study. J Clin Oncol 27:3027-3035