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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01190644
Recruitment Status : Terminated (Isotope needed to conduct RBC/PV analysis (primary endpoint) no longer available from manufacturer. No alternatives available for use.)
First Posted : August 27, 2010
Last Update Posted : June 6, 2016
Information provided by (Responsible Party):
Celgene Corporation

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 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: ACE 011 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : June 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: ACE 011 (Sotatercept)
35mg dose of ACE 011 will be given by subcutaneous injection on Day 1. Up to two additional doses of ACE 011 will be given every 42 days during the treatment period (Day 43 and Day 85)
Drug: ACE 011
35 mg subcutaneous (SC) dose on study Day 1, Day 43, Day 85
Other Name: Sotatercept

Primary Outcome Measures :
  1. Red Blood Cell Mass [ Time Frame: Up to One Year ]

Secondary Outcome Measures :
  1. Plasma Volume [ Time Frame: Up to One Year ]
  2. Absolute Reticulocyte Increase [ Time Frame: Up to One Year ]
  3. Changes in Hemoglobin [ Time Frame: Up to One Year ]
  4. Number of patients with adverse events [ Time Frame: Up to One Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01190644

United States, Maryland
Saint Agnes Healthcare
Baltimore, Maryland, United States, 21229
Weinberg Cancer Institution at Franklin Square
Baltimore, Maryland, United States, 21237
United States, Pennsylvania
Pennsylvania Oncology
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Celgene Corporation
Study Director: Abderrahmane Laadem, MD Celgene

Responsible Party: Celgene Corporation Identifier: NCT01190644     History of Changes
Other Study ID Numbers: ACE-011-ST-001
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: May 2016

Keywords provided by Celgene Corporation:
Red Blood Cell Mass
Plasma Volume
Solid Tumors