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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:
ClinicalTrials.gov Identifier:
NCT00931606
First Posted: July 2, 2009
Last Update Posted: November 17, 2017
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.
Information provided by (Responsible Party):
Celgene
  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
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

Resource links provided by NLM:


Further study details as provided by Celgene:

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 ]

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 ]

Enrollment: 30
Actual Study Start Date: June 1, 2009
Study Completion Date: November 18, 2010
Primary Completion Date: November 18, 2010 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


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

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00931606     History of Changes
Other Study ID Numbers: A011-08
First Submitted: May 22, 2009
First Posted: July 2, 2009
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Celgene:
anemia
metastatic
breast
cancer

Additional relevant MeSH terms:
Anemia
Hematologic Diseases