Trial · NCT00931606
Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
NCT00931606, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2023-09-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012). Trials, record NCT00931606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00931606
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
- NCT number
- NCT00931606
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chemotherapy Induced Anemia
- Interventions
- Sotatercept, Placebo
- First posted
- 2009-07-02
- Last updated
- 2023-09-13
- Results first posted
- 2023-09-13
- 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.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Hematopoietic Response | 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. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~175 Days | 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. |
| Secondary | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | Up to ~85 Days | 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. |
| Secondary | 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 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. |
| Secondary | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | 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. |
| Secondary | 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 | 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. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | Baseline and Up to ~145 Days | 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. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL | Baseline and Up to ~145 Days | 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. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | 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. |
| Secondary | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | Baseline and Up to ~145 Days | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved a Hematopoietic Response | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~175 Days | All participants who received at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | Up to ~85 Days | All participants who received at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study treatment for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| SECONDARY | 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 | All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days). | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥1 g/dL and less than 2 g/dL increase from baseline. | Days | MEAN |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥2 g/dL and less than 11 g/dL increase from baseline. | Days | MEAN |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥11 g/dL increase from baseline. | Days | MEAN |
| SECONDARY | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | Baseline and Up to ~145 Days | All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline. | Days | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group250
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved a Hematopoietic Response | Sotatercept 0.1 mg/kg | Overall | 0 | 95% Confidence Interval 0 to 52.2 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | Sotatercept 0.3 mg/kg | Overall | 33.3 | 95% Confidence Interval 7.5 to 70.1 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | Sotatercept 0.5 mg/kg | Overall | 50.0 | 95% Confidence Interval 6.8 to 93.2 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | Placebo | Overall | 20.0 | 95% Confidence Interval 0.5 to 71.6 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | All Sotatercept-treated Participants | Overall | 27.8 | 95% Confidence Interval 9.7 to 53.5 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | Sotatercept 0.1 mg/kg | Received weekly chemotherapy and showed a response | 0 | 95% Confidence Interval 0 to 84.2 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | Sotatercept 0.3 mg/kg | Received weekly chemotherapy and showed a response | 0 | 95% Confidence Interval 0 to 84.2 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | Sotatercept 0.5 mg/kg | Received weekly chemotherapy and showed a response | 25.0 | 95% Confidence Interval 2.5 to 100.0 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | Placebo | Received weekly chemotherapy and showed a response | 20 | 95% Confidence Interval 2.5 to 100.0 | Percentage of Participants |
| Percentage of Participants Who Achieved a Hematopoietic Response | All Sotatercept-treated Participants | Received weekly chemotherapy and showed a response | 5.6 | 95% Confidence Interval 0.5 to 71.6 | Percentage of Participants |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sotatercept 0.1 mg/kg | 8 | |
| Overall Study | STARTED | Sotatercept 0.3 mg/kg | 10 | |
| Overall Study | STARTED | Sotatercept 0.5 mg/kg | 7 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Sotatercept 0.1 mg/kg | 3 | |
| Overall Study | COMPLETED | Sotatercept 0.3 mg/kg | 1 | |
| Overall Study | COMPLETED | Sotatercept 0.5 mg/kg | 1 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Sotatercept 0.1 mg/kg | 5 | |
| Overall Study | NOT COMPLETED | Sotatercept 0.3 mg/kg | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events750
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sotatercept 0.1 mg/kg | 1 | 8 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Sotatercept 0.3 mg/kg | 3 | 10 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Sotatercept 0.5 mg/kg | 2 | 7 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 5 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Total | 7 | 30 | 7 |
| other | Leukocytosis | Blood and lymphatic system disorders | Sotatercept 0.1 mg/kg | 0 | 8 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Sotatercept 0.3 mg/kg | 0 | 10 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Sotatercept 0.5 mg/kg | 1 | 7 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 0 | 5 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Total | 1 | 30 | 1 |
1 to 10 of 750Source ClinicalTrials.gov
See all 750 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sotatercept 0.1 mg/kg | 1 | 8 |
| Total, all-cause mortality | Sotatercept 0.3 mg/kg | 3 | 10 |
| Total, all-cause mortality | Sotatercept 0.5 mg/kg | 3 | 7 |
| Total, all-cause mortality | Placebo | 0 | 5 |
| Total, all-cause mortality | Total | 7 | 30 |
| Total, other adverse events | Sotatercept 0.1 mg/kg | 6 | 8 |
| Total, other adverse events | Sotatercept 0.3 mg/kg | 7 | 10 |
| Total, other adverse events | Sotatercept 0.5 mg/kg | 7 | 7 |
| Total, other adverse events | Placebo | 5 | 5 |
| Total, other adverse events | Total | 25 | 30 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26370220 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00931606
GET https://conductscience.org/api/trials/v1/NCT00931606/registered?page=2