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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

This study has been terminated.
(Isotope needed to conduct RBC/PV analysis (primary endpoint) no longer available from manufacturer. No alternatives available for use.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01190644
First Posted: August 27, 2010
Last Update Posted: June 6, 2016
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.
Information provided by (Responsible Party):
Celgene Corporation
July 21, 2010
August 27, 2010
June 6, 2016
June 2010
September 2012   (Final data collection date for primary outcome measure)
Red Blood Cell Mass [ Time Frame: Up to One Year ]
Same as current
Complete list of historical versions of study NCT01190644 on ClinicalTrials.gov Archive Site
  • Plasma Volume [ Time Frame: Up to One Year ]
  • Absolute Reticulocyte Increase [ Time Frame: Up to One Year ]
  • Changes in Hemoglobin [ Time Frame: Up to One Year ]
  • Number of patients with adverse events [ Time Frame: Up to One Year ]
Same as current
Not Provided
Not Provided
 
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
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 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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Solid Tumors
Drug: ACE 011
35 mg subcutaneous (SC) dose on study Day 1, Day 43, Day 85
Other Name: Sotatercept
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)
Intervention: Drug: ACE 011
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01190644
ACE-011-ST-001
No
Not Provided
Not Provided
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Abderrahmane Laadem, MD Celgene
Celgene Corporation
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP