Last reviewed · How we verify
Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia
Phase 2 trial testing Sotatercept in Anemia in 56 participants. Completed in 24 May 2022.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 21 February 2013 |
| Primary completion | 24 May 2022 |
| Estimated completion | 24 May 2022 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Anemia or Myelodysplastic/Myeloproliferative Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Monotherapy (Sotatercept) | 8 | |
| Treatment Combination (Ruxolitinib + Sotatercept) | 6 |
Response date to loss of response or last follow up.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Monotherapy (Sotatercept) | 23.3 | 3.9 – 68.4 |
| Treatment Combination (Ruxolitinib + Sotatercept) | 19.9 | 3.7 – 56.8 |
Time frame: Up to 9 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment Monotherapy (Sot… | Treatment Combination (Rux… |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Fever | General disorders | — | — |
| Infections and infestations | Infections and infestations | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Chest wall pain | General disorders | — | — |
| Chills | General disorders | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Enterocolitis | Gastrointestinal disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Headache | Nervous system disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Non cardiac chest pain | General disorders | — | — |
| Pain in extremity | General disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Skin infection | Infections and infestations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Wound infection | Infections and infestations | — | — |
| Reaction | System | Treatment Monotherapy (Sot… | Treatment Combination (Rux… |
|---|---|---|---|
| Pain | General disorders | — | — |
| Flu like symptoms | General disorders | — | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — | — |
| Renal and urinary disorders | Renal and urinary disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | — | — |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — | — |
| Bleeding Hemorrhage | General disorders | — | — |
| Psychiatric Disorders | Psychiatric disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Cardiac disorders | Cardiac disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Elevated Albumin/Creatinine Ratio | Investigations | — | — |
| Infection | Infections and infestations | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Peripheral neuropathy | Nervous system disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Rash maculo papular | Skin and subcutaneous tissue disorders | — | — |
| elevated transaminase levels | Investigations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Fever | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Flushing | Vascular disorders | — | — |
| Headache | General disorders | — | — |
| Hot flashes | Vascular disorders | — | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — | — |
| Iron overload | Metabolism and nutrition disorders | — | — |
| Paresthesia | Nervous system disorders | — | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — | — |
| Sinusitis | Infections and infestations | — | — |
| Tinnitus | Ear and labyrinth disorders | — | — |
| Weight loss | Investigations | — | — |
| Allergic reaction | Immune system disorders | — | — |
Most-reported serious reactions: Anemia, Lung infection, Dyspnea, Fever, Infections and infestations, Neoplasms benign, malignant and unspecified (incl cysts and polyps), Acute kidney injury, Chest wall pain.
Data from ClinicalTrials.gov NCT01712308 adverse events section.
This phase II trial studies the side effects of and how well sotatercept works in treating patients with myeloproliferative neoplasm-associated myelofibrosis or anemia. Sotatercept may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01712308.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing