Chemotherapy Induced AnemiaPhase 2NCT00931606
Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
A Phase 2 study testing Sotatercept in people with Chemotherapy Induced Anemia, run by Merck Sharp & Dohme LLC at 35 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy Induced Anemia
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 1 Jun 2009to 18 Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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).
- Has received treatment with another investigational drug or device within 1 month prior to Day 1.
- Is pregnant or lactating.
- Has a history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product.
- Has had major surgery within 30 days prior to Day 1 (patients must have completely recovered from any previous surgery prior to Day 1).
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States28 sites
Investigative Site
Austin, Texas
Investigative Site
Baltimore, Maryland
Investigative Site
Beverly Hills, California
Investigative Site
Bismarck, North Dakota
Investigative Site
Boynton Beach, Florida
Investigative Site
Charleston, South Carolina
Investigative Site
Corona, California
Investigative Site
Dallas, Texas
Investigative Site
Denver, Colorado
Investigative Site
Evansville, Indiana
Investigative Site
Fountain Valley, California
Investigative Site
Goldsboro, North Carolina
Investigative Site
Grand Rapids, Michigan
Investigative Site
High Point, North Carolina
Investigative Site
Hinsdale, Illinois
Investigative Site
Hot Springs, Arkansas
Investigative Site
Kansas City, Missouri
Investigative Site
Lacey, Washington
Investigative Site
Middletown, Ohio
Investigative Site
Montebello, California
Investigative Site
Nyack, New York
Investigative Site
Philadelphia, Pennsylvania
Investigative Site
Riverside, California
Investigative Site
Sedona, Arizona
Investigative Site
Tupelo, Mississippi
Investigative Site
Tyler, Texas
Investigative Site
Wichita, Kansas
Investigative Site
Winston-Salem, North Carolina
Russia7 sites
Investigative Site
Krasnodar
Investigative Site
Moscow
Investigative Site
Nizhny Novgorod
Investigative Site
Nizhny Novograd (2)
Investigative Site
Pyatigorsk
Investigative Site
Saint Petersburg
Investigative Site
Stavropol
About this study
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
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).
- Conditions
- Chemotherapy Induced Anemia
- Being tested
- Sotatercept, Placebo
- Keywords
- anemia, metastatic, breast, cancer
- Medical subject headings
- Anemia, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called ACE-011
up to 4 subcutaneous doses of sotatercept given once every 28 days
PlaceboDrug
up to 4 subcutaneous doses of placebo given once every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept 0.1 mg/kg | Experimental | Participants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses. Receives: Biological: Sotatercept |
| Sotatercept 0.3 mg/kg | Experimental | Participants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses. Receives: Biological: Sotatercept |
| Sotatercept 0.5 mg/kg | Experimental | Participants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses. Receives: Biological: Sotatercept |
| Placebo | Placebo comparator | Participants will receive placebo subcutaneously every 28 days up to 4 doses. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Up to ~145 Days
Secondary outcomes (21)
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported.
Measured: Up to ~175 Days
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study intervention due to AEs is reported.
Measured: Up to ~85 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL
Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented.
Measured: Baseline and Up to ~145 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL
Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented.
Measured: 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
Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented.
Measured: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline
Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline
Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline
Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL
Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL
Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented.
Measured: Baseline and Up to ~145 Days
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA
The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented.
Measured: Up to Day 141
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1).
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented.
Measured: Baseline and Day 64
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 64 is presented.
Measured: Day 64
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 113 is presented.
Measured: Day 113
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 113 is presented.
Measured: Day 113
Progression-free Survival (PFS)
PFS was defined as the time from start of the chemotherapy regimen (which could have occurred prior to study start and collected as prior anticancer therapy) to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 is presented.
Measured: From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study start1 Jun 2009
- Primary completion18 Nov 2010
- Study completion18 Nov 2010
Why it stopped: administrative reasons (slow patient enrollment)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced AnemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp and Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931606
- Sponsor's protocol ID
- 7962-012
- Other IDs
- A011-08, MK-7962-012
- Status last verified
- Aug 2023
- First submitted
- 22 May 2009
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 26370220
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00931606
- Acronym / sponsor ID
- 7962-012
- Conditions
- Chemotherapy Induced Anemia
- Keywords
- anemia, metastatic, breast, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: administrative reasons (slow patient enrollment)
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 18 Nov 2010 (actual)
- Study completion
- 18 Nov 2010 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sotatercept 0.1 mg/kg | Experimental | Biological: SotaterceptParticipants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses. |
| Sotatercept 0.3 mg/kg | Experimental | Biological: SotaterceptParticipants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses. |
| Sotatercept 0.5 mg/kg | Experimental | Biological: SotaterceptParticipants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo subcutaneously every 28 days up to 4 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotaterceptAlso: ACE-011up to 4 subcutaneous doses of sotatercept given once every 28 days | Biological | Sotatercept 0.1 mg/kg, Sotatercept 0.3 mg/kg, Sotatercept 0.5 mg/kg |
| Placeboup to 4 subcutaneous doses of placebo given once every 28 days | Drug | Placebo |
Primary outcome
Percentage of Participants Who Achieved a Hematopoietic Response
Time frame: Baseline and Up to ~145 Days
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.
21 secondary outcomes
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to ~175 Days
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event
Time frame: Up to ~85 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL
Time frame: Baseline and Up to ~145 Days
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL
Time frame: 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
Time frame: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL
Time frame: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL
Time frame: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL
Time frame: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL
Time frame: Baseline and Up to ~145 Days
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL
Time frame: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline
Time frame: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline
Time frame: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline
Time frame: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL
Time frame: Baseline and Up to ~145 Days
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL
Time frame: Baseline and Up to ~145 Days
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA
Time frame: Up to Day 141
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1).
Time frame: Baseline and Day 64
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1.
Time frame: Day 64
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1.
Time frame: Day 113
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1.
Time frame: Day 113
Progression-free Survival (PFS)
Time frame: From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26370220Raftopoulos 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.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp and Dohme LLC
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sotatercept in people with Chemotherapy Induced Anemia, run by Merck Sharp & Dohme LLC at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved a Hematopoietic Response (time frame: Baseline and Up to ~145 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00931606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.