A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe

Phase 1 Completed 119 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.

Timeline

Start: 2011-04
Primary completion: 2012-01
Completion: 2012-01

Publications

Wynne CJ, Ellis-Pegler RB, Waaka DS, Schwabe C, Lehle M, Heinzmann D, Mangat R, Li C, Dick AE, Cranshaw NA, Lum BL. Comparative pharmacokinetics of subcutaneous trastuzumab administered via handheld syringe or proprietary single-use injection device in healthy males. Cancer Chemother Pharmacol. 2013 Nov;72(5):1079-87. doi: 10.1007/s00280-013-2273-z. Epub 2013 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Trastuzumab	Monoclonal antibody	600 mg	Subcutaneous

Indications

No indication recorded.