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

We found this trial at

sites

University of Maryland

Baltimore, Maryland 20742

(301) 405-1000