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
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Men and women ≥18 years of age.
- Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology or biopsy.
- Presence of metastatic disease.
- Hemoglobin value between ≥8.0 to <11.0 g/dL (≥80 to <110 g/L).
- ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume test) since previous treatment with erythropoiesis-stimulating agent (including concurrent treatment with intravenous [IV] iron).
- ≥28 days must have elapsed (prior to Day 1) since the last red blood cell transfusion and receipt of ≤2 units of blood in the past 56 days (prior to Day 1).
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 1.
Exclusion criteria
At the time of screening, participants who have any grade ≥3 toxicity (according to the currently active minor version of NCI CTCAE v4.0) except for the following disease-related toxicities:
- Hematological events - anemia, thrombocytopenia, neutropenia
- Non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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