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

This study has been terminated.
(administrative reasons (slow patient enrollment))
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00931606
First received: May 22, 2009
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Chemotherapy Induced Anemia
 Biological: Biological: ACE-011
Drug: Placebo
 Phase 2

Study Type: 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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931606

  Show 39 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Gary Renshaw, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Gary Renshaw, MD, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00931606     History of Changes
Other Study ID Numbers: A011-08
Study First Received: May 22, 2009
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
anemia
metastatic
breast
cancer

Additional relevant MeSH terms:
Anemia
Breast Neoplasms
Hematologic Diseases
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013