Neugranin in Breast Cancer Patients Receiving Doxorubicin/Docetaxel (NEUGR-003)

Condition(s) targeted: Chemotherapy-Induced Neutropenia

Intervention: Neugranin (Biological); Pegfilgrastim (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Teva Pharmaceutical Industries

Official(s) and/or principal investigator(s):
Andrew Rankin, PhD, Study Director, Affiliation: Teva Pharmaceutical Industries

Overall contact:
Please provide NCT#, Email: ustevatrials@teva.co.il

Determination of the effect of Neugranin on the duration and severity of severe neutropenia in subjects receiving doxorubicin in combination with docetaxel.

Official title: A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Duration of severe neutropenia

Secondary outcome: Incidence of febrile neutropenia

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Breast cancer patients scheduled to receive the AT regimen (doxorubicin/ docetaxel)

Exclusion Criteria:

- Subjects may have received no more than 1 prior chemotherapy regimen (including

adjuvant therapy if given within the last 12 months)

Please provide NCT#, Email: ustevatrials@teva.co.il

Teva Investigational Site, Gabrovo, Bulgaria; Recruiting

Teva Investigational Site, Plovdiv, Bulgaria; Recruiting

Teva Investigational Site, Ruse, Bulgaria; Recruiting

Teva Investigational Site, Shumen, Bulgaria; Recruiting

Teva Investigational Site, Sofia, Bulgaria; Recruiting

Teva Investigational Site, Stara Zagora, Bulgaria; Recruiting

Teva Investigational Site, Varna, Bulgaria; Recruiting

Teva Investigational Site, Veliko Tarnovo, Bulgaria; Recruiting

Teva Investigational Site, Baia Mare, Romania; Recruiting

Teva Investigational Site, Brasov, Romania; Recruiting

Teva Investigational Site, Bucharest, Romania; Recruiting

Teva Investigational Site, Cluj Napoca, Romania; Recruiting

Teva Investigational Site, Craiova, Romania; Recruiting

Teva Investigational Site, Lasi, Romania; Recruiting

Teva Investigational Site, Timisoara, Romania; Recruiting

Teva Investigational Site, Arkhangelsk, Russian Federation; Not yet recruiting

Teva Investigational Site, Chelyabinsk, Russian Federation; Not yet recruiting

Teva Investigational Site, Ekaterinburg, Russian Federation; Not yet recruiting

Teva Investigational Site, Ivanovo, Russian Federation; Not yet recruiting

Teva Investigational Site, Kazan, Russian Federation; Not yet recruiting

Teva Investigational Site, Krasnodar, Russian Federation; Not yet recruiting

Teva Investigational Site, Kursk, Russian Federation; Not yet recruiting

Teva Investigational Site, Moscow, Russian Federation; Not yet recruiting

Teva Investigational Site, Nizhny Novgorod, Russian Federation; Not yet recruiting

Teva Investigational Site, Orel, Russian Federation; Not yet recruiting

Teva Investigational Site, Pyatigorsk, Russian Federation; Not yet recruiting

Teva Investigational Site, Rostov-on-Don, Russian Federation; Not yet recruiting

Teva Investigational Site, Saint Petersburg, Russian Federation; Not yet recruiting

Teva Investigational Site, Samara, Russian Federation; Not yet recruiting

Teva Investigational Site, Sochi, Russian Federation; Not yet recruiting

Teva Investigational Site, Tambov, Russian Federation; Not yet recruiting

Teva Investigational Site, Ufa, Russian Federation; Not yet recruiting

Teva Investigational Site, Yaroslavl, Russian Federation; Not yet recruiting

Teva Investigational Site, Belgrade, Serbia; Recruiting

Teva Investigational Site, Kragujevac, Serbia; Recruiting

Teva Investigational Site, Nis, Serbia; Recruiting

Teva Investigational Site, Chernihiv, Ukraine; Recruiting

Teva Investigational Site, Chernivtsi, Ukraine; Recruiting

Teva Investigational Site, Dnipropetrovsk, Ukraine; Recruiting

Teva Investigational Site, Donetsk, Ukraine; Recruiting

Teva Investigational Site, Ivano-Frankivsk, Ukraine; Recruiting

Teva Investigational Site, Kharkiv, Ukraine; Recruiting

Teva Investigational Site, Khmelnytsky, Ukraine; Recruiting

Teva Investigational Site, Kyiv, Ukraine; Recruiting

Teva Investigational Site, Lviv, Ukraine; Recruiting

Teva Investigational Site, Mariupol, Ukraine; Recruiting

Teva Investigational Site, Odesa, Ukraine; Recruiting

Teva Investigational Site, Sumy, Ukraine; Recruiting

Teva Investigational Site, Uzhhorod, Ukraine; Recruiting

Starting date: June 2010
Last updated: August 24, 2010