Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors

Phase 2TerminatedNCT01190644

Merck Sharp & Dohme LLC5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Solid Tumors

Interventions

SotaterceptDRUG

single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 red blood cell mass / plasma volume test) since previous treatment with erythropoiesis-stimulating agent (including concurrent treatment with intravenous \[IV\] iron). * ≥28 days must have elapsed (prior to Day 1) since the last red blood cell 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, participants 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

Locations (3)

Saint Agnes Healthcare

Baltimore, Maryland, United States

Weinberg Cancer Institution at Franklin Square

Baltimore, Maryland, United States

Pennsylvania Oncology

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept

Blood samples were to be collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in red blood cell mass following a single dose of sotatercept.

Time frame: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28

Secondary Outcomes

Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept

Blood samples were collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in plasma volume following a single dose of sotatercept.

Time frame: Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28

Change From Baseline in Absolute Reticulocyte Count

Blood samples were to be collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in absolute reticulocyte count.

Time frame: Baseline (Day 1, pre-dose) and Day 211

Change From Baseline in Erythropoietin Levels

Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels.

Time frame: Baseline (Day 1, pre-dose) and Day 211

Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept

Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A following a single dose of sotatercept.

Time frame: Baseline (Day 1, pre-dose) and Day 29

Data from ClinicalTrials.gov

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