Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Completed · Phase 2
Conditions studied: Neutropenia
In brief
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.
Key facts
- Study ID
- NCT01724866
- Run by
- Spectrum Pharmaceuticals, Inc
- People needed
- 148
- Starts
- 2013-03-25
- Expected to finish
- 2014-08-12
- Last updated by the study team
- 2022-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy
- Candidate for docetaxel and cyclophosphamide chemotherapy
- Female or male at least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Absolute neutrophil count (ANC) ≥ 1.5×109/L
- Platelet count ≥ 100 x 10\^9/L
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L).
- Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN
- Hemoglobin > 9 g/dL
- Alkaline phosphatase ≤ 1.5 x ULN
You may not qualify if…
- Known sensitivity to E. coli-derived products or known sensitivity to any of the products to be administered
- Known Human Immunodeficiency Virus (HIV) infection
- Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease
- Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment
- Prior bone marrow or stem cell transplant
- Prolonged exposure to glucocorticosteroids and immunosuppressive agents
Where it is running
- Arizona Center for Cancer Care — Glendale, Arizona, United States
- Desert Springs Cancer Care — Scottsdale, Arizona, United States
- California Cancer Associates for Research and Excellence — Fresno, California, United States
- Beaver Medical Group — Highland, California, United States
- California Cancer Associates for Research and Excellence — Los Angeles, California, United States
- Innovative Clinical Research Institute — Whittier, California, United States
- Kentucky Cancer Clinic — Hazard, Kentucky, United States
- New York Oncology Hematology, PC — Albany, New York, United States
- North Shore Hematology/Oncology Associates — Setauket, New York, United States
- Good Samaritan Hospital, Corvallis — Corvallis, Oregon, United States
- Frankston Hospital — Frankston, Victoria, Australia
- Royal Hobart — Brisbane, Australia
- Ashford Cancer Center Research — Kurralta Park, Australia
- Breast Cancer Research Center, WA — Perth, Australia
- Ballarat Oncology & Haematology — Wendouree, Australia
- LTD " Cancer Center of Adjara Autonomic Republic" — Batumi, Georgia
- Ltd ' Medulla - Chemotherapy and Immunotherapy Clinic — Tbilisi, Georgia
- State Health Center — Budapest, Hungary
- National Institute of Oncology — Budapest, Hungary
- Uzsoki Hospital — Budapest, Hungary
- University Debrecen, Oncology Clinic — Debrecen, Hungary
- Szabolcs - Szatmár - Bereg megyei Kórházak és Egyetemi Oktatókórház — Nyíregyháza, Hungary
- Ziv Medical Center — Safed, Israel
- Regionalny Szpital Specjalistyczny — Grudziądz, Poland
- Szpital Uniwersytecki w Krakowie — Krakow, Poland
Full record on ClinicalTrials.gov
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