Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Subjects With Solid Tumors
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2013 |
Start Date: | June 2010 |
End Date: | June 2013 |
Contact: | Abderrahmane Laadem, MD |
Email: | alaadem@celgene.com |
Phone: | 908-673-9068 |
A Phase 2, Open-Label, Pharmacodynamic Study to Evaluate the Effect of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Subjects With Solid Tumors
What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by
dosing with 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, ACE-011 pharmacodynamic
study, completed by two well known experts in the red cell production field.
Inclusion Criteria:
1. Men and women ≥ 18 years of age.
2. Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology
or biopsy.
3. Presence of metastatic disease.
4. Hemoglobin value between ≥ 8.0 to < 11.0 g/dL (≥ 80 to < 110 g/L).
5. ≥ 28 days must have elapsed (prior to pre-dose RBC mass / PV test) since previous
treatment with erythropoiesis-stimulating agent (including concurrent treatment with
IV iron).
6. ≥ 28 days must have elapsed (prior to Day 1) since the last RBC blood transfusion and
receipt of ≤ 2 units of blood in the past 56 days (prior to Day 1).
7. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 1.
Exclusion Criteria:
At the time of screening, subjects 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
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