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: Terminated
• Trial end date: 2012-09-18
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

Criteria

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