Status:
TERMINATED
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
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01190644
Start Date
June 1 2010
End Date
October 29 2012
Last Update
November 29 2023
Active Locations (3)
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1
Saint Agnes Healthcare
Baltimore, Maryland, United States, 21229
2
Weinberg Cancer Institution at Franklin Square
Baltimore, Maryland, United States, 21237
3
Pennsylvania Oncology
Philadelphia, Pennsylvania, United States, 19106