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Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors
Phase 2 trial testing Sotatercept in Solid Tumors in 5 participants. Terminated before completion.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 5 |
| Start date | 1 June 2010 |
| Primary completion | 18 September 2012 |
| Estimated completion | 29 October 2012 |
| Sites | 3 locations across United States |
Merck Sharp & Dohme LLC — full company profile →
18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Blood samples were collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in plasma volume following a single dose of sotatercept.
| Group | Value | 95% CI |
|---|---|---|
| Sotatercept | -239.50 | ± 219.91 |
Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels.
| Group | Value | 95% CI |
|---|---|---|
| Sotatercept | 11.30 | 11.3 – 11.3 |
Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A following a single dose of sotatercept.
| Group | Value | 95% CI |
|---|---|---|
| Sotatercept | 0.0 | 0.0 – 0.0 |
Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A2 following a single dose of sotatercept.
| Group | Value | 95% CI |
|---|---|---|
| Sotatercept | 0.0 | 0.0 – 0.0 |
Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype C following a single dose of sotatercept.
| Group | Value | 95% CI |
|---|---|---|
| Sotatercept | 0.0 | 0.0 – 0.0 |
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
| Group | Value | 95% CI |
|---|---|---|
| Sotatercept | 4 |
Time frame: Up to approximately 7 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Sotatercept 35 mg |
|---|---|---|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | — |
| CARDIOGENIC SHOCK | Cardiac disorders | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — |
| PNEUMOPERITONEUM | Gastrointestinal disorders | — |
| DEVICE DISLOCATION | General disorders | — |
| INFECTED SKIN ULCER | Infections and infestations | — |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | — |
| DEHYDRATION | Metabolism and nutrition disorders | — |
| HYPONATRAEMIA | Metabolism and nutrition disorders | — |
| Reaction | System | Sotatercept 35 mg |
|---|---|---|
| VOMITING | Gastrointestinal disorders | — |
| OEDEMA PERIPHERAL | General disorders | — |
| ANAEMIA | Blood and lymphatic system disorders | — |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | — |
| MYOCARDIAL INFARCTION | Cardiac disorders | — |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | — |
| ASCITES | Gastrointestinal disorders | — |
| CONSTIPATION | Gastrointestinal disorders | — |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | — |
| NAUSEA | Gastrointestinal disorders | — |
| DEVICE RELATED INFECTION | Infections and infestations | — |
| ESCHERICHIA INFECTION | Infections and infestations | — |
| NASOPHARYNGITIS | Infections and infestations | — |
| ORAL CANDIDIASIS | Infections and infestations | — |
| WOUND INFECTION STAPHYLOCOCCAL | Infections and infestations | — |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | — |
| DEHYDRATION | Metabolism and nutrition disorders | — |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | — |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | — |
| HYPOKALAEMIA | Metabolism and nutrition disorders | — |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | — |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | — |
| HEADACHE | Nervous system disorders | — |
| ANXIETY | Psychiatric disorders | — |
| INSOMNIA | Psychiatric disorders | — |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | — |
| ERYTHEMA | Skin and subcutaneous tissue disorders | — |
| SKIN ULCER | Skin and subcutaneous tissue disorders | — |
| HYPERTENSION | Vascular disorders | — |
| HYPOTENSION | Vascular disorders | — |
Most-reported serious reactions: CARDIO-RESPIRATORY ARREST, CARDIOGENIC SHOCK, ABDOMINAL PAIN, PNEUMOPERITONEUM, DEVICE DISLOCATION, INFECTED SKIN ULCER, PROCEDURAL PAIN, DEHYDRATION.
Data from ClinicalTrials.gov NCT01190644 adverse events section.
What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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