Comparative pharmacokinetics of subcutaneous trastuzumab administered via handheld syringe or proprietary single-use injection device in healthy males

Cancer Chemotherapy and Pharmacology

Volumn 72, Issue 5, 2013, Pages 1079-1087

  Wynne, Chris J ^a   Ellis Pegler, Rod B ^b   Waaka, Devonie S ^a   Schwabe, Christian ^b   Lehle, Michaela ^c   Heinzmann, Dominik ^c   Mangat, Ranvir ^d   Li, Chunze ^d   Dick, Anne E ^a   Cranshaw, Nicola A ^b   Lum, Bert L ^d  

^a Christchurch Clinical Studies Trust   (New Zealand)

^b Auckland Clinical Studies Ltd   (New Zealand)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

^d GENENTECH INC   (United States)

Author keywords

Clinical trials; Devices; Pharmacokinetics; Phase I

Indexed keywords

DRUG ANTIBODY; TRASTUZUMAB; ANTINEOPLASTIC AGENT; CELL ADHESION MOLECULE; EXCIPIENT; HYALURONIDASE PH-20; HYALURONOGLUCOSAMINIDASE; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ADULT; ANTIBODY DETECTION; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BIOLOGICAL MONITORING; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DELIVERY DEVICE; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; FEVER; HEAD INJURY; HEART DISEASE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION; INJECTION SITE PAIN; INTERMETHOD COMPARISON; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SYRINGE; BLOOD; CHEMISTRY; CLINICAL TRIAL; COMPARATIVE STUDY; DEVICES; DISPOSABLE EQUIPMENT; DRUG DELIVERY SYSTEM; DRUG SELF ADMINISTRATION; HALF LIFE TIME; IMMUNOLOGY; MATERIALS TESTING; METABOLISM; MULTICENTER STUDY; NEW ZEALAND; SUBCUTANEOUS DRUG ADMINISTRATION; YOUNG ADULT;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; CELL ADHESION MOLECULES; DISPOSABLE EQUIPMENT; DRUG DELIVERY SYSTEMS; DRUG HYPERSENSITIVITY; EXCIPIENTS; HALF-LIFE; HUMANS; HYALURONOGLUCOSAMINIDASE; INJECTIONS, SUBCUTANEOUS; MALE; MATERIALS TESTING; NEW ZEALAND; RECOMBINANT PROTEINS; SELF ADMINISTRATION; SYRINGES; YOUNG ADULT;

EID: 84887152731     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2273-z     Document Type: Article

References (12)

1. Aebi S, Davidson T, Gruber G, Cardoso F, ESMO Guidelines Working Group (2011) Primary breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 22:vi12-vi24
2. Cardoso F, Harbeck N, Fallowfield L, Kyriakides S, Senkus E, ESMO Guidelines Working Group (2012) Locally recurrent or metastatic breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 23:vii11-vii19
3. National Comprehensive Cancer Network (2013) NCCN clinical practice guidelines in oncology: Breast cancer V1
4. Herceptin: Summary of Product Characteristics (2011) available at http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000278/WC500074922.pdf. Accessed 24 June 2013
5. Bittner B, Richter WF, Hourcade-Potelleret F, McIntyre C, Herting F, Zepeda ML, Schmidt J (2012) Development of a subcutaneous formulation for trastuzumab - nonclinical and clinical bridging approach to the approved intravenous dosing regimen. Arzneimittelforschung 62:401-409
6. Bookbinder LH, Hofer A, Haller MF, Zepeda ML, Keller GA, Lim JE, Edgington TS, Shepard HM, Patton JS, Frost GI (2006) A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release 114:230-241 (Pubitemid 44291844)
7. Wynne C, Harvey V, Schwabe C, Waaka D, McIntyre C, Bittner B (2013) Comparison of subcutaneous and intravenous administration of trastuzumab: a phase I/Ib trial in healthy male volunteers and patients with HER2-positive breast cancer. J Clin Pharmacol 53:192-201
8. Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, Pienkowski T, Lichinitser M, Semiglazov V, Melichar B, Jackisch C (2012) Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol 13:869-878
9. Huskisson EC (1974) Measurement of pain. Lancet 2:1127-1131
10. Singer AJ, Thode HC Jr (1998) Determination of the minimal clinically significant difference on a patient visual analog satisfaction scale. Acad Emerg Med 5:1007-1111
11. European Medicines Agency Committee for Medicinal Products for Human Use (2010) Guideline on the investigation of bioequivalence. EMA, London
12. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (2001) Guidance for industry: statistical approaches to establishing bioequivalence. FDA, Rockville