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

PHASE2CompletedINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

March 25, 2013

Primary Completion Date

August 12, 2014

Study Completion Date

August 12, 2014

Conditions
Neutropenia
Interventions
DRUG

SPI-2012

SPI-2012 SC injection.

DRUG

Pegfilgrastim

Pegfilgrastim SC injection, per manufacturer's Prescribing Information.

DRUG

Docetaxel

Docetaxel given based on standard dose for chemotherapy.

DRUG

Cyclophosphamide

Cyclophosphamide given based on standard dose for chemotherapy.

Trial Locations (27)

1062

State Health Center, Budapest

1122

National Institute of Oncology, Budapest

1146

Uzsoki Hospital, Budapest

3199

Frankston Hospital, Frankston

3355

Ballarat Oncology & Haematology, Wendouree

4032

University Debrecen, Oncology Clinic, Debrecen

5037

Ashford Cancer Center Research, Kurralta Park

6000

Breast Cancer Research Center, WA, Perth

"LTD Cancer Center of Adjara Autonomic Republic", Batumi

7000

Royal Hobart, Brisbane

11733

North Shore Hematology/Oncology Associates, Setauket

12206

New York Oncology Hematology, PC, Albany

13100

Ziv Medical Center, Safed

41701

Kentucky Cancer Clinic, Hazard

85255

Desert Springs Cancer Care, Scottsdale

85306

Arizona Center for Cancer Care, Glendale

90603

Innovative Clinical Research Institute, Whittier

92025

California Cancer Associates for Research and Excellence, Los Angeles

92346

Beaver Medical Group, Highland

93720

California Cancer Associates for Research and Excellence, Fresno

97330

Good Samaritan Hospital, Corvallis, Corvallis

0186

Ltd ' Medulla - Chemotherapy and Immunotherapy Clinic, Tbilisi

Unknown

Szabolcs - Szatmár - Bereg megyei Kórházak és Egyetemi Oktatókórház, Nyíregyháza

86-300

Regionalny Szpital Specjalistyczny, Grudziądz

31-501

Szpital Uniwersytecki w Krakowie, Krakow

47-400

Dzienny Oddział Chemioterapii, Racibórz

02-106

MTZ Clinical Research Sp. z o.o., Warsaw

All Listed Sponsors
lead

Spectrum Pharmaceuticals, Inc

INDUSTRY

NCT01724866 - Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer | Biotech Hunter | Biotech Hunter