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

Sponsor

Celgene (Industry)

Overall Status

Terminated

CT.gov ID

NCT01190644

Collaborator

(none)

Enrollment

Locations

Arm

27.6

Actual Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

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

Actual Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Sep 18, 2012

Actual Study Completion Date :

Sep 18, 2012

Arms and Interventions

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 Names: Sotatercept

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 Names:

Sotatercept

Outcome Measures

Primary Outcome Measures

Red Blood Cell Mass [Up to One Year]

Secondary Outcome Measures

Plasma Volume [Up to One Year]
Absolute Reticulocyte Increase [Up to One Year]
Changes in Hemoglobin [Up to One Year]
Number of patients with adverse events [Up to One Year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women ≥ 18 years of age.
Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology or biopsy.
Presence of metastatic disease.
Hemoglobin value between ≥ 8.0 to < 11.0 g/dL (≥ 80 to < 110 g/L).
≥ 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).
≥ 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).
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

Locations

	Site	City	State	Country	Postal Code
1	Saint Agnes Healthcare	Baltimore	Maryland	United States	21229
2	Weinberg Cancer Institution at Franklin Square	Baltimore	Maryland	United States	21237
3	Pennsylvania Oncology	Philadelphia	Pennsylvania	United States	19106