Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

Summary

The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.

Timeline

Start

2013-03-25

Primary completion

2014-08-12

Completion

2014-08-12

Outcome

Met primary endpoint

paper Noninferiority to pegfilgrastim was demonstrated at 135 μg/kg (P = 0.002) and 270 μg/kg (P < .001), with superiority demonstrated at 270 μg/kg PMID 29573207 ↗

release “SPI-2012 met the primary endpoint in a multicenter Phase 2 study” hanmipharm.com ↗

Publications

• Vacirca JL, Chan A, Mezei K, Adoo CS, Papai Z, McGregor K, Okera M, Horvath Z, Landherr L, Hanslik J, Hager SJ, Ibrahim EN, Rostom M, Bhat G, Choi MR, Reddy G, Tedesco KL, Agajanian R, Lang I, Schwartzberg LS. An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer. Cancer Med. 2018 May;7(5):1660-1669. doi: 10.1002/cam4.1388. Epub 2018 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous
Subject	SPI-2012	Protein / enzyme biologic	45 ug/kg	Subcutaneous
Subject	SPI-2012	Protein / enzyme biologic	135 ug/kg	Subcutaneous
Subject	SPI-2012	Protein / enzyme biologic	270 ug/kg	Subcutaneous
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous

Indications