Study Stopped
administrative reasons (slow patient enrollment)
Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
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
3 other identifiers
interventional
30
2 countries
35
Brief Summary
The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with metastatic breast cancer. Hematopoietic response was defined as an increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of sotatercept in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2009
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2010
CompletedResults Posted
Study results publicly available
September 13, 2023
CompletedSeptember 13, 2023
August 1, 2023
1.5 years
May 22, 2009
May 22, 2023
August 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved a Hematopoietic Response
Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.
Baseline and Up to ~145 Days
Secondary Outcomes (21)
Number of Participants Who Experienced an Adverse Event (AE)
Up to ~175 Days
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event
Up to ~85 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL
Baseline and Up to ~145 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL
Baseline and Up to ~145 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL
Baseline and Up to ~145 Days
- +16 more secondary outcomes
Study Arms (4)
Sotatercept 0.1 mg/kg
EXPERIMENTALParticipants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
Sotatercept 0.3 mg/kg
EXPERIMENTALParticipants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
Sotatercept 0.5 mg/kg
EXPERIMENTALParticipants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Placebo
PLACEBO COMPARATORParticipants will receive placebo subcutaneously every 28 days up to 4 doses.
Interventions
up to 4 subcutaneous doses of sotatercept given once every 28 days
Eligibility Criteria
You may qualify if:
- Has a histologically confirmed diagnosis of breast cancer documented by cytology or biopsy.
- Has evidence of metastatic breast cancer with a minimum of one lesion per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v 1.1) criteria.
- Is receiving a chemotherapy regimen including one of the following: anthracycline, taxane, gemcitabine, vinorelbine or capecitabine.
- Has planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after Day 1 of study intervention administration.
- ≥ 30 days elapsed (from Day 1) since previous treatment with an erythropoiesis stimulating agent (ESA) (including treatment with intravenous (IV) iron) for chemotherapy induced anemia.
- ≥ 7 days elapsed (from Day 1) since the last red blood cell (RBC) transfusion and receipt of ≤ 2 units of blood in the past 30 days.
- Life expectancy of ≥ 6 months.
You may not qualify if:
- Has had prior radiation therapy to \> 20% of the whole skeleton.
- Has had \> 5 prior chemotherapy treatment regimens for metastatic breast cancer.
- Has a history of autoimmune or hereditary hemolysis or gastrointestinal bleeding.
- Has clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic or genitourinary disease unrelated to underlying hematologic disorder.
- Has heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher.
- Has a recent history of thrombosis, deep vein thrombosis (DVT), pulmonary emboli, or embolic stroke, occurring within the last 6 months.
- Has untreated central nervous system (CNS) metastases or CNS metastases treated with whole brain radiotherapy \< 6 months prior to Day 1.
- Has a diagnosis of a myeloid malignancy or known history of myelodysplasia.
- Has a history of second malignancy within 5 years (except excised and cured basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ).
- Has had administration of IV antibiotics or febrile (temperature elevation \> 38 ° C) within 14 days of Day 1.
- Has uncontrolled hypertension.
- Has known history of hepatitis B surface antigen (HBsAg and HB core antibody (Ab)), human immunodeficiency virus (HIV) antibody or active hepatitis C.
- Has clinically significant iron (transferrin saturation \< 20%), vitamin B12, or folate deficiency.
- Has a history of anemia as a result of inherited hemoglobinopathy such as sickle cell anemia or thalassemia.
- Has a history of autoimmune or hereditary hemolysis; active gastrointestinal bleeding (within the last 6 months as compared to Day 1).
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Investigative Site
Sedona, Arizona, United States
Investigative Site
Hot Springs, Arkansas, United States
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
Investigative Site
Denver, Colorado, United States
Investigative Site
Boynton Beach, Florida, United States
Investigative Site
Hinsdale, Illinois, United States
Investigative Site
Evansville, Indiana, United States
Investigative Site
Wichita, Kansas, United States
Investigative Site
Baltimore, Maryland, United States
Investigative Site
Grand Rapids, Michigan, United States
Investigative Site
Tupelo, Mississippi, United States
Investigative Site
Kansas City, Missouri, United States
Investigative Site
Nyack, New York, United States
Investigative Site
Goldsboro, North Carolina, United States
Investigative Site
High Point, North Carolina, United States
Investigative Site
Winston-Salem, North Carolina, United States
Investigative Site
Bismarck, North Dakota, United States
Investigative Site
Middletown, Ohio, United States
Investigative Site
Philadelphia, Pennsylvania, United States
Investigative Site
Charleston, South Carolina, United States
Investigative Site
Austin, Texas, United States
Investigative Site
Dallas, Texas, United States
Investigative Site
Tyler, Texas, United States
Investigative Site
Lacey, Washington, United States
Investigative Site
Krasnodar, Russia
Investigative Site
Moscow, Russia
Investigative Site
Nizhny Novgorod, Russia
Investigative Site
Nizhny Novograd (2), Russia
Investigative Site
Pyatigorsk, Russia
Investigative Site
Saint Petersburg, Russia
Investigative Site
Stavropol, Russia
Related Publications (1)
Raftopoulos H, Laadem A, Hesketh PJ, Goldschmidt J, Gabrail N, Osborne C, Ali M, Sherman ML, Wang D, Glaspy JA, Puccio-Pick M, Zou J, Crawford J. Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies. Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 2015 Sep 14.
PMID: 26370220BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This is an acquired study. No restrictions were imposed on time on current chemotherapy prior to study entry, therefore PFS could have gone beyond the study duration. The time from start of current chemotherapy could have occurred prior to study start and collected as prior anticancer therapy, therefore the upper limit of the confidence interval in the "Sotatercept 0.5 mg/kg" arm, "1791.0 days", didn't exceed the timeframe of 281 days after study start.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp and Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2009
First Posted
July 2, 2009
Study Start
June 1, 2009
Primary Completion
November 18, 2010
Study Completion
November 18, 2010
Last Updated
September 13, 2023
Results First Posted
September 13, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf