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Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00931606
Recruitment Status : Terminated (administrative reasons (slow patient enrollment))
First Posted : July 2, 2009
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
Anemia can be caused by the chemotherapy treatment that is used to treat metastatic breast cancer. This study will be used to find out if ACE-011 can help treat chemotherapy induced anemia in patients with metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Anemia Biological: Biological: ACE-011 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 1, 2009
Actual Primary Completion Date : November 18, 2010
Actual Study Completion Date : November 18, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
ACE-011 Treatment Group (Dose Level 1)
Biological: Biological: ACE-011
up to 4 subcutaneous doses of ACE-011 given once every 28 days
Other Name: ActRIIA-IgG1

Experimental: 2
ACE-011 Treatment Group (Dose Level 2)
Biological: Biological: ACE-011
up to 4 subcutaneous doses of ACE-011 given once every 28 days
Other Name: ActRIIA-IgG1

Experimental: 3
ACE-011 Treatment Group (Dose Level 3)
Biological: Biological: ACE-011
up to 4 subcutaneous doses of ACE-011 given once every 28 days
Other Name: ActRIIA-IgG1

Placebo Comparator: 4
Placebo
Drug: Placebo
up to 4 subcutaneous doses of placebo given once every 28 days




Primary Outcome Measures :
  1. 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 [ Time Frame: 1-6 months ]

Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of ACE-011 for the treatment of chemotherapy induced anemia in patients with metastatic breast cancer [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931606


Locations
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United States, Arizona
Investigative Site
Sedona, Arizona, United States
United States, Arkansas
Investigative Site
Hot Springs, Arkansas, United States
United States, California
Investigative Site
Beverly Hills, California, United States
Investigative Site
Corona, California, United States
Investigative Site
Fountain Valley, California, United States
Investigative Site
Montebello, California, United States
Investigative Site
Riverside, California, United States
United States, Colorado
Investigative Site
Denver, Colorado, United States
United States, Florida
Investigative Site
Boynton Beach, Florida, United States
United States, Illinois
Investigative Site
Hinsdale, Illinois, United States
United States, Indiana
Investigative Site
Evansville, Indiana, United States
United States, Kansas
Investigative Site
Wichita, Kansas, United States
United States, Maryland
Investigative Site
Baltimore, Maryland, United States
United States, Michigan
Investigative Site
Grand Rapids, Michigan, United States
United States, Mississippi
Investigative Site
Tupelo, Mississippi, United States
United States, Missouri
Investigative Site
Kansas City, Missouri, United States
United States, New York
Investigative Site
Nyack, New York, United States
United States, North Carolina
Investigative Site
Goldsboro, North Carolina, United States
Investigative Site
High Point, North Carolina, United States
Investigative Site
Winston-Salem, North Carolina, United States
United States, North Dakota
Investigative Site
Bismarck, North Dakota, United States
United States, Ohio
Investigative Site
Middletown, Ohio, United States
United States, Pennsylvania
Investigative Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
Investigative Site
Charleston, South Carolina, United States
United States, Texas
Investigative Site
Austin, Texas, United States
Investigative Site
Dallas, Texas, United States
Investigative Site
Tyler, Texas, United States
United States, Washington
Investigative Site
Lacey, Washington, United States
Russian Federation
Investigative Site
Krasnodar, Russian Federation
Investigative Site
Moscow (1), Russian Federation
Investigative Site
Moscow (2), Russian Federation
Investigative Site
Nizhny Novgorod, Russian Federation
Investigative Site
Nizhny Novograd (2), Russian Federation
Investigative Site
Pyatigorsk, Russian Federation
Investigative Site
St. Petersburg (1), Russian Federation
Investigative Site
St. Petersburg (2), Russian Federation
Investigative Site
St. Petersburg (3), Russian Federation
Investigative Site
St. Petersburg (4), Russian Federation
Investigative Site
Stavropol, Russian Federation
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Gary Renshaw, MD Celgene
Publications:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00931606    
Other Study ID Numbers: A011-08
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Celgene:
anemia
metastatic
breast
cancer
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases