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

Sponsor

Celgene (Industry)

Overall Status

Terminated

CT.gov ID

NCT00931606

Collaborator

(none)

Enrollment

Locations

Arms

17.6

Actual Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jun 1, 2009

Actual Primary Completion Date :

Nov 18, 2010

Actual Study Completion Date :

Nov 18, 2010

Arms and Interventions

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 Names: 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 Names: 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 Names: ActRIIA-IgG1
Placebo Comparator: 4 Placebo	Drug: Placebo up to 4 subcutaneous doses of placebo given once every 28 days

Outcome Measures

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 [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 [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Investigative Site	Sedona	Arizona	United States
2	Investigative Site	Hot Springs	Arkansas	United States
3	Investigative Site	Beverly Hills	California	United States
4	Investigative Site	Corona	California	United States
5	Investigative Site	Fountain Valley	California	United States
6	Investigative Site	Montebello	California	United States
7	Investigative Site	Riverside	California	United States
8	Investigative Site	Denver	Colorado	United States
9	Investigative Site	Boynton Beach	Florida	United States
10	Investigative Site	Hinsdale	Illinois	United States
11	Investigative Site	Evansville	Indiana	United States
12	Investigative Site	Wichita	Kansas	United States
13	Investigative Site	Baltimore	Maryland	United States
14	Investigative Site	Grand Rapids	Michigan	United States
15	Investigative Site	Tupelo	Mississippi	United States
16	Investigative Site	Kansas City	Missouri	United States
17	Investigative Site	Nyack	New York	United States
18	Investigative Site	Goldsboro	North Carolina	United States
19	Investigative Site	High Point	North Carolina	United States
20	Investigative Site	Winston-Salem	North Carolina	United States
21	Investigative Site	Bismarck	North Dakota	United States
22	Investigative Site	Middletown	Ohio	United States
23	Investigative Site	Philadelphia	Pennsylvania	United States
24	Investigative Site	Charleston	South Carolina	United States
25	Investigative Site	Austin	Texas	United States
26	Investigative Site	Dallas	Texas	United States
27	Investigative Site	Tyler	Texas	United States
28	Investigative Site	Lacey	Washington	United States
29	Investigative Site	Krasnodar		Russian Federation
30	Investigative Site	Moscow (1)		Russian Federation
31	Investigative Site	Moscow (2)		Russian Federation
32	Investigative Site	Nizhny Novgorod		Russian Federation
33	Investigative Site	Nizhny Novograd (2)		Russian Federation
34	Investigative Site	Pyatigorsk		Russian Federation
35	Investigative Site	St. Petersburg (1)		Russian Federation
36	Investigative Site	St. Petersburg (2)		Russian Federation
37	Investigative Site	St. Petersburg (3)		Russian Federation
38	Investigative Site	St. Petersburg (4)		Russian Federation
39	Investigative Site	Stavropol		Russian Federation