A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID).
Phase of Trial: Phase I
Latest Information Update: 15 Sep 2015
At a glance
- Drugs Trastuzumab (Primary)
- Indications Breast cancer; Gastric cancer
- Focus Pharmacokinetics
- Sponsors Roche
- 23 May 2013 Actual initiation date changed from Mar 2012 to Jan 2012 as reported by ClinicalTrials.gov.
- 18 Apr 2012 Actual end date (Mar 2012) added as reported by ClinicalTrials.gov.
- 15 Feb 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.