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
  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:


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 April 16, 2014