A Phase 2 interventional study of Sotatercept and Placebo in Chemotherapy Induced Anemia, sponsored by Merck Sharp & Dohme LLC. Terminated at 39 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
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).
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This study's enrollment of 30 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
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Exclusion Criteria:
Participants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.
Biological: Sotatercept
Participants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.
Biological: Sotatercept
Participants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Biological: Sotatercept
Participants will receive placebo subcutaneously every 28 days up to 4 doses.
Drug: Placebo
up to 4 subcutaneous doses of sotatercept given once every 28 days
Also known as: ACE-011
up to 4 subcutaneous doses of placebo given once every 28 days
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.
Time frame: Baseline and Up to ~145 Days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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 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.
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 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.
Time frame: 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.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281
This study was terminated early after 30 participants were enrolled due to slower than expected rate of enrollment as a result of changes in guidance for the treatment of participants with breast cancer and chemotherapy induced anemia (CIA).
| Milestone | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Started | 8 | 10 | 7 | 5 |
| Completed | 3 | 1 | 1 | 2 |
| Not completed | 5 | 9 | 6 | 3 |
| Withdrew: Death | 1 | 3 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 3 | 0 |
| Withdrew: Sponsor decision | 1 | 4 | 0 | 2 |
| Withdrew: Withdrawal by subject | 3 | 1 | 1 | 1 |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | All Sotatercept-treated Participants |
|---|---|---|---|---|---|
| Overall | 0 (0 to 52.2) | 33.3 (7.5 to 70.1) | 50.0 (6.8 to 93.2) | 20.0 (0.5 to 71.6) | 27.8 (9.7 to 53.5) |
| Received weekly chemotherapy and showed a response | 0 (0 to 84.2) | 0 (0 to 84.2) | 25.0 (2.5 to 100.0) | 20 (2.5 to 100.0) | 5.6 (0.5 to 71.6) |
| Received less frequent chemotherapy and showed a response | 0 (0 to 70.8) | 33.3 (9.9 to 81.6) | 25.0 (0.8 to 90.6) | 0 (0 to 60.2) | 22.2 (9.1 to 61.4) |
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.
| Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 6 | 7 | 7 | 5 |
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.
| Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | 1 | 0 | 4 | 1 |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | All Sotatercept-treated Participants |
|---|---|---|---|---|---|
| Overall | 0 (0 to 52.2) | 11.1 (0.3 to 48.2) | 0 (0 to 60.2) | 0 (0 to 52.2) | 5.6 (0.1 to 27.3) |
| Received weekly chemotherapy and showed a response | 0 (0 to 84.2) | 0 (0 to 84.2) | 0 (0 to 97.5) | 0 (0 to 97.5) | 0 (0 to 52.2) |
| Received less frequent chemotherapy and showed a response | 0 (0 to 70.8) | 11.1 (0.4 to 57.9) | 0 (0 to 70.8) | 0 (0 to 60.2) | 5.6 (0.2 to 36.0) |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | All Sotatercept-treated Participants |
|---|---|---|---|---|---|
| Overall | 20.0 (0.5 to 71.6) | 22.2 (2.8 to 60.0) | 75.0 (19.4 to 99.4) | 20.0 (0.5 to 71.6) | 33.3 (13.3 to 59.0) |
| Received weekly chemotherapy and showed a response | 0 (0 to 84.2) | 11.1 (1.3 to 98.7) | 25.0 (2.5 to 100.0) | 20.0 (2.5 to 100.0) | 11.1 (5.3 to 85.3) |
| Received less frequent chemotherapy and showed a response | 20.0 (0.8 to 90.6) | 11.1 (0.4 to 57.9) | 50.0 (9.4 to 99.2) | 0 (0 to 60.2) | 22.2 (9.1 to 61.4) |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | All Sotatercept-treated Participants |
|---|---|---|---|---|---|
| Overall | 20.0 (0.5 to 71.6) | 22.2 (2.8 to 60.0) | 75.0 (19.4 to 99.4) | 20.0 (0.5 to 71.6) | 33.3 (13.3 to 59.0) |
| Received weekly chemotherapy and showed a response | 0 (0 to 84.2) | 11.1 (1.3 to 98.7) | 25.0 (2.5 to 100.0) | 20.0 (2.5 to 100.0) | 11.1 (5.3 to 85.3) |
| Received less frequent chemotherapy and showed a response | 20.0 (0.8 to 90.6) | 11.1 (0.4 to 57.9) | 50.0 (9.4 to 99.2) | 0 (0 to 60.2) | 22.2 (9.1 to 61.4) |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | — | 47.0 ± 20.30 | 46.5 ± 14.85 | 29.0 ± NA |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL | — | 69.0 ± NA | — | — |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | — | 41.0 ± NA | 50.0 ± 9.90 | 29.0 ± NA |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | — | 47.0 ± 20.30 | 50.0 ± 9.90 | 29.0 ± NA |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL | — | 69.0 ± NA | 50.0 ± 9.90 | 29.0 ± NA |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline | — | NA (72.0 to NA) | NA (6.0 to NA) | NA (112 to NA) |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline | — | NA (NA to NA) | — | — |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline | NA (28.0 to NA) | NA (100.0 to NA) | 56.0 (6.0 to NA) | NA (112.0 to NA) |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL | NA (28.0 to NA) | NA (21.0 to NA) | 56.0 (6.0 to NA) | NA (112.0 to NA) |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL | NA (28.0 to NA) | NA (NA to NA) | 56.0 (6.0 to NA) | NA (112.0 to NA) |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Overall RBC Transfusions | 0 | 33.3 | 25.0 | 0 |
| Overall ESAs | 0 | 11.1 | 0 | 0 |
| Overall Received RBC Transfusions or ESAs | 0 | 44.4 | 25.0 | 0 |
| Day 1 to Prior to Day 29 RBC Transfusions | 0 | 11.1 | 25.0 | 0 |
| Day 1 to Prior to Day 29 ESAs | 0 | 0 | 0 | 0 |
| Day 1 to Prior to Day 29 Received RBC Transfusions or ESAs | 0 | 11.1 | 25.0 | 0 |
| Day 29 to Prior to Day 57 RBC Transfusions | 0 | 22.2 | 0 | 0 |
| Day 29 to Prior to Day 57 ESAs | 0 | 0 | 0 | 0 |
| Day 29 to Prior to Day 57 Received RBC Transfusions or ESAs | 0 | 22.2 | 0 | 0 |
| Day 57 to Prior to Day 85 RBC Transfusions | 0 | 0 | 25.0 | 0 |
| Day 57 to Prior to Day 85 ESAs | 0 | 11.1 | 0 | 0 |
| Day 57 to Prior to Day 85 Received RBC Transfusions or ESAs | 0 | 11.1 | 25.0 | 0 |
| Day 85 to Prior to Day 141 RBC Transfusions | 0 | 11.1 | 25.0 | 0 |
| Day 85 to Prior to Day 141 ESAs | 0 | 0 | 0 | 0 |
| Day 85 to Prior to Day 141 Received RBC Transfusions or ESAs | 0 | 11.1 | 25.0 | 0 |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Complete Response | 0 | 33.3 | 0 | 0 |
| Partial Response | 0 | 16.7 | 0 | 0 |
| Stable Disease | 100.0 | 16.7 | 100.0 | 50.0 |
| Progressive Disease | 0 | 16.7 | 0 | 0 |
| Not Evaluable | 0 | 0 | 0 | 0 |
| Not Applicable | 0 | 16.7 | 0 | 50.0 |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Complete Response | 0 | 0 | 0 | 0 |
| Progressive Disease | 50.0 | 33.3 | 0 | 50.0 |
| Non-complete Response/Non-progressive disease | 50.0 | 50.0 | 100.0 | 25.0 |
| Not Evaluable | 0 | 0 | 0 | 0 |
| Not Applicable | 0 | 16.7 | 0 | 25.0 |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Complete Response | 0 | 0 | 0 | 0 |
| Partial Response | 0 | 0 | 0 | 0 |
| Stable Disease | 100.0 | 0 | 0 | 33.3 |
| Progressive Disease | 0 | 0 | 0 | 0 |
| Not Evaluable | 0 | 0 | 0 | 0 |
| Not Applicable | 0 | 100.0 | 100.0 | 66.7 |
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.
| Percentage of Participants | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo |
|---|---|---|---|---|
| Complete Response | 0 | 0 | 0 | 0 |
| Progressive Disease | 0 | 0 | 100.0 | 33.3 |
| Non-complete Response/Non-progressive disease | 100.0 | 50.0 | 0 | 33.3 |
| Not Evaluable | 0 | 50.0 | 0 | 0 |
| Not Applicable | 0 | 0 | 0 | 33.3 |
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.
| Days | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | All Sotatercept-treated Participants |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | 188.0 (64.0 to 188.0) | 196.0 (97.0 to 219.0) | 187.0 (134.0 to 1791.0) | 157.0 (84.0 to NA) | 169.0 (108.0 to 219.0) |
Collected over Up to Day 281. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | 1/8 (12.5%) | 0/8 (0%) | 6/8 (75%) |
| Sotatercept 0.3 mg/kg | 3/10 (30%) | 2/10 (20%) | 7/10 (70%) |
| Sotatercept 0.5 mg/kg | 3/7 (42.9%) | 3/7 (42.9%) | 7/7 (100%) |
| Placebo | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Total | 7/30 (23.3%) | 6/30 (20%) | 25/30 (83.3%) |
| Event | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 0/8 | 1/10 | 2/7 | 0/5 | 3/30 |
| VomitingGastrointestinal disorders | 0/8 | 1/10 | 2/7 | 0/5 | 3/30 |
| FatigueGeneral disorders | 0/8 | 0/10 | 0/7 | 1/5 | 1/30 |
| AnaemiaBlood and lymphatic system disorders | 0/8 | 0/10 | 1/7 | 0/5 | 1/30 |
| Gastric ulcer perforationGastrointestinal disorders | 0/8 | 0/10 | 1/7 | 0/5 | 1/30 |
| Peptic ulcerGastrointestinal disorders | 0/8 | 0/10 | 1/7 | 0/5 | 1/30 |
| AstheniaGeneral disorders | 0/8 | 0/10 | 1/7 | 0/5 | 1/30 |
| AnorexiaMetabolism and nutrition disorders | 0/8 | 0/10 | 1/7 | 0/5 | 1/30 |
| DehydrationMetabolism and nutrition disorders | 0/8 | 1/10 | 1/7 | 0/5 | 2/30 |
| Breast cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/8 | 1/10 | 1/7 | 0/5 | 2/30 |
| Event | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 4/8 | 0/10 | 2/7 | 3/5 | 9/30 |
| NauseaGastrointestinal disorders | 0/8 | 1/10 | 2/7 | 3/5 | 6/30 |
| VomitingGastrointestinal disorders | 1/8 | 0/10 | 3/7 | 1/5 | 5/30 |
| LeukopeniaBlood and lymphatic system disorders | 3/8 | 0/10 | 0/7 | 2/5 | 5/30 |
| DiarrhoeaGastrointestinal disorders | 0/8 | 1/10 | 1/7 | 2/5 | 4/30 |
| AstheniaGeneral disorders | 3/8 | 2/10 | 2/7 | 2/5 | 9/30 |
| FatigueGeneral disorders | 1/8 | 1/10 | 2/7 | 2/5 | 6/30 |
| HeadacheNervous system disorders | 1/8 | 0/10 | 2/7 | 2/5 | 5/30 |
| AnaemiaBlood and lymphatic system disorders | 1/8 | 3/10 | 2/7 | 1/5 | 7/30 |
| Musculoskeletal chest painMusculoskeletal and connective tissue disorders | 0/8 | 3/10 | 1/7 | 0/5 | 4/30 |
| Age, Continuous(Years) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 51.6 ± 9.38 | 50.8 ± 8.51 | 55.6 ± 12.53 | 49.2 ± 10.62 | 51.9 ± 9.83 |
| Sex: Female, Male(Participants) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 8 | 10 | 7 | 5 | 30 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 8 | 10 | 7 | 4 | 29 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Weight(Kilograms) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 67.38 ± 18.338 | 71.80 ± 9.500 | 69.94 ± 9.953 | 79.62 ± 9.926 | 71.49 ± 12.647 |
| Chemotherapy Frequency(Participants) | Sotatercept 0.1 mg/kg | Sotatercept 0.3 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Weekly | 2 | 2 | 1 | 1 | 6 |
| Less Frequently | 6 | 8 | 6 | 4 | 24 |
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