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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Solid Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Red Blood Cell Mass

Outcome Time Frame:

Up to One Year

Safety Issue:

Yes

Principal Investigator

Abderrahmane Laadem, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

ACE-011-ST-001

NCT ID:

NCT01190644

Start Date:

June 2010

Completion Date:

August 2013

Related Keywords:

  • Solid Tumors
  • Red Blood Cell Mass
  • Plasma Volume
  • Solid Tumors
  • Neoplasms

Name

Location

Weinberg Cancer Institution at Franklin SquareBaltimore, Maryland  21237
Saint Agnes HealthcareBaltimore, Maryland  21229
Pennsylvania OncologyPhiladelphia, Pennsylvania  19106