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A Phase 2, Double-blind, Randomized, Placebo-Controlled Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Chemotherapy Induced Anemia

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Trial Information

A Phase 2, Double-blind, Randomized, Placebo-Controlled Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer


Inclusion Criteria:



- Histologically confirmed diagnosis of breast cancer documented by cytology or biopsy

- Evidence of metastatic breast cancer with a minimum of one lesion per RECIST criteria

- Receiving a chemotherapy regimen including one of the following: anthracycline,
taxane, gemcitabine or vinorelbine

- Planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after
Day 1 of study drug administration

- Hemoglobin value between ≥ 6.5 to < 11.0 g/dL

- Life expectancy of ≥ 6 months

Exclusion Criteria:

- Prior radiation therapy to > 20% of the whole skeleton

- > 5 prior chemotherapy treatment regimens for metastatic breast cancer

- Untreated CNS metastases (exception: CNS metastases treated with whole brain
radiotherapy > 6 months prior to randomization)

- Uncontrolled hypertension

- History of anemia as a result of inherited hemoglobinopathy

- History of autoimmune or hereditary hemolysis or gastrointestinal bleeding

- Pregnant or lactating

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To evaluate the proportion of patients that have a hematopoietic response when ACE-011 is administered for the treatment of chemotherapy induced anemia in patients with metastatic breast cancer

Outcome Time Frame:

1-6 months

Safety Issue:

No

Principal Investigator

Gary Renshaw, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

A011-08

NCT ID:

NCT00931606

Start Date:

June 2009

Completion Date:

April 2011

Related Keywords:

  • Chemotherapy Induced Anemia
  • anemia
  • metastatic
  • breast
  • cancer
  • Anemia
  • Breast Neoplasms

Name

Location

Investigative SiteSedona, Arizona  
Investigative SiteHot Springs, Arkansas  
Investigative SiteBeverly Hills, California  
Investigative SiteDenver, Colorado  
Investigative SiteBoynton Beach, Florida  
Investigative SiteHinsdale, Illinois  
Investigative SiteEvansville, Indiana  
Investigative SiteWichita, Kansas  
Investigative SiteBaltimore, Maryland  
Investigative SiteGrand Rapids, Michigan  
Investigative SiteTupelo, Mississippi  
Investigative SiteKansas City, Missouri  
Investigative SiteNyack, New York  
Investigative SiteGoldsboro, North Carolina  
Investigative SiteBismarck, North Dakota  
Investigative SiteMiddletown, Ohio  
Investigative SitePhiladelphia, Pennsylvania  
Investigative SiteCharleston, South Carolina  
Investigative SiteAustin, Texas  
Investigative SiteLacey, Washington