Trial · NCT01712308
Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia
NCT01712308, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2023-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia. Trials, record NCT01712308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01712308
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia
- NCT number
- NCT01712308
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Anemia, Myelodysplastic/Myeloproliferative Neoplasm, Myelofibrosis
- Interventions
- Sotatercept, Ruxolitinib
- First posted
- 2012-10-23
- Last updated
- 2023-10-10
- Results first posted
- 2023-06-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anemia-response | Up to 84 days | Defined as an increase in hemoglobin level equal to or greater than 1.5 g/L without red blood cell-transfusion OR becoming red blood cell-transfusion-independent in a patient who is red blood cell-transfusion-dependent. Will be based on the intent-to-treat principle. |
| Primary | Duration of Response | Up to 9 years | Response date to loss of response or last follow up. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Anemia-response | Up to 84 days | Of the 35 participants on the monotherapy arm, 27 were evaluable for response. Of the 21 participants on the Combination Therapy arm, 19 were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Duration of Response | Up to 9 years | Of the 35 participants on the monotherapy arm, 27 were evaluable for response. Of the 21 participants on the Combination Therapy arm, 19 were evaluable for response. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Anemia-response | Treatment Monotherapy (Sotatercept) | 8 | Participants | ||
| Anemia-response | Treatment Combination (Ruxolitinib + Sotatercept) | 6 | Participants | ||
| Duration of Response | Treatment Monotherapy (Sotatercept) | 23.3 | Full Range 3.9 to 68.4 | Months | |
| Duration of Response | Treatment Combination (Ruxolitinib + Sotatercept) | 19.9 | Full Range 3.7 to 56.8 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Monotherapy (Sotatercept) | 35 | |
| Overall Study | STARTED | Treatment Combination (Ruxolitinib + Sotatercept) | 21 | |
| Overall Study | COMPLETED | Treatment Monotherapy (Sotatercept) | 35 | |
| Overall Study | COMPLETED | Treatment Combination (Ruxolitinib + Sotatercept) | 21 | |
| Overall Study | NOT COMPLETED | Treatment Monotherapy (Sotatercept) | 0 | |
| Overall Study | NOT COMPLETED | Treatment Combination (Ruxolitinib + Sotatercept) | 0 |
Source ClinicalTrials.gov
Adverse events134
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 | Allergic reaction | Immune system disorders | Treatment Monotherapy (Sotatercept) | 0 | 35 | 0 |
| other | Allergic reaction | Immune system disorders | Treatment Combination (Ruxolitinib + Sotatercept) | 1 | 21 | 1 |
| other | Cardiac disorders | Cardiac disorders | Treatment Monotherapy (Sotatercept) | 5 | 35 | 7 |
| other | Cardiac disorders | Cardiac disorders | Treatment Combination (Ruxolitinib + Sotatercept) | 5 | 21 | 5 |
| other | Constipation | Gastrointestinal disorders | Treatment Monotherapy (Sotatercept) | 5 | 35 | 5 |
| other | Constipation | Gastrointestinal disorders | Treatment Combination (Ruxolitinib + Sotatercept) | 5 | 21 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Treatment Monotherapy (Sotatercept) | 9 | 35 | 9 |
| other | Diarrhea | Gastrointestinal disorders | Treatment Combination (Ruxolitinib + Sotatercept) | 8 | 21 | 8 |
| other | Dizziness | Nervous system disorders | Treatment Monotherapy (Sotatercept) | 6 | 35 | 8 |
| other | Dizziness | Nervous system disorders | Treatment Combination (Ruxolitinib + Sotatercept) | 4 | 21 | 5 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Monotherapy (Sotatercept) | 0 | 35 |
| Total, all-cause mortality | Treatment Combination (Ruxolitinib + Sotatercept) | 0 | 21 |
| Total, other adverse events | Treatment Monotherapy (Sotatercept) | 30 | 35 |
| Total, other adverse events | Treatment Combination (Ruxolitinib + Sotatercept) | 19 | 21 |
| Total, serious adverse events | Treatment Monotherapy (Sotatercept) | 11 | 35 |
| Total, serious adverse events | Treatment Combination (Ruxolitinib + Sotatercept) | 10 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Monotherapy (Sotatercept) vs Treatment Combination (Ruxolitinib + Sotatercept): Anemia-response | Trial comparisons |
| Treatment Monotherapy (Sotatercept) vs Treatment Combination (Ruxolitinib + Sotatercept): deaths from any cause | Trial comparisons |
| Treatment Monotherapy (Sotatercept) vs Treatment Combination (Ruxolitinib + Sotatercept): serious adverse events | Trial comparisons |
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/NCT01712308
GET https://conductscience.org/api/trials/v1/NCT01712308/events?page=2