Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

January 31, 2013

Study Completion Date

February 28, 2013

Conditions
Chemotherapy-induced Neutropenia
Interventions
BIOLOGICAL

empegfilrastim

Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.

BIOLOGICAL

filgrastim

Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.

Trial Locations (5)

163045

Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk

197758

N.N.Petrov Oncology Research Center, Saint Petersburg

400138

Volgograd District Oncology Dispensary №1, Volgograd

614066

Perm Region Oncology Dispensary, Perm

Unknown

Russian scientific center of radiology and surgery technologies, Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

NCT01569087 - Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer | Biotech Hunter | Biotech Hunter