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

Phase 2 Completed 148 enrolled Spectrum Pharmaceuticals, Inc

RandomizedParallel-groupOpen-labelTreatment

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

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	Eflapegrastim	Protein / enzyme biologic	45 ug/kg	Subcutaneous
Subject	Eflapegrastim	Protein / enzyme biologic	135 ug/kg	Subcutaneous
Subject	Eflapegrastim	Protein / enzyme biologic	270 ug/kg	Subcutaneous
Subject	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications