A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)

Phase 1 Completed 88 enrolled Hoffmann-La Roche

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be compared using a compilation of pharmacokinetic (PK) parameters such as area under the concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm the dosing regimen in women with EBC on the basis of safety, tolerability, and PK assessments.

Timeline

Start: 2016-06-23
Primary completion: 2018-05-31
Completion: 2018-05-31

Outcome

Met primary endpoint

paper A maintenance dose of 600 mg for SC pertuzumab resulted in an equivalent exposure to that of IV pertuzumab PMID 30570763 ↗

Publications

Kirschbrown WP, Wynne C, Kagedal M, Wada R, Li H, Wang B, Nijem I, Badovinac Crnjevic T, Gasser H, Heeson S, Eng-Wong J, Garg A. Development of a Subcutaneous Fixed-Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose-Finding Study. J Clin Pharmacol. 2019 May;59(5):702-716. doi: 10.1002/jcph.1362. Epub 2018 Dec 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pertuzumab	Monoclonal antibody	400 mg	Intravenous
Subject	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Subject	Pertuzumab	Monoclonal antibody	600 mg	Intravenous
Subject	Pertuzumab	Monoclonal antibody	1200 mg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	600 mg	Subcutaneous