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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:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01190644
First received: July 21, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Solid Tumors
 Drug: ACE 011
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Red Blood Cell Mass [ Time Frame: Up to One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma Volume [ Time Frame: Up to One Year ] [ Designated as safety issue: No ]
  • Absolute Reticulocyte Increase [ Time Frame: Up to One Year ] [ Designated as safety issue: No ]
  • Changes in Hemoglobin [ Time Frame: Up to One Year ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: Up to One Year ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190644

Locations
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
Investigators
Study Director: Abderrahmane Laadem, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01190644     History of Changes
Other Study ID Numbers: ACE-011-ST-001
Study First Received: July 21, 2010
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013