NCT01190644 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2023-11-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Change From Baseline in Absolute Reticulocyte Count

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outcome · POSTED

Change From Baseline in Erythropoietin Levels

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outcome · POSTED

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

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outcome · POSTED

Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept

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outcome · POSTED

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

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outcome · POSTED

Number of Participants Who Experienced One or More Adverse Events (AEs)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants will receive a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85.
intervention Names
Drug: Sotatercept
label
Sotatercept
type
EXPERIMENTAL

interventions

arm Group Labels
Sotatercept
description
single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85
name
Sotatercept
other Names
ACE 011
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 5
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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

description
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.
measure
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
description
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.
measure
Change From Baseline in Absolute Reticulocyte Count
time Frame
Baseline (Day 1, pre-dose) and Day 211
description
Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels.
measure
Change From Baseline in Erythropoietin Levels
time Frame
Baseline (Day 1, pre-dose) and Day 211
description
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.
measure
Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept
time Frame
Baseline (Day 1, pre-dose) and Day 29
description
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 A2 following a single dose of sotatercept.
measure
Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept
time Frame
Baseline (Day 1, pre-dose) and Day 29
description
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 C following a single dose of sotatercept.
measure
Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept
time Frame
Baseline (Day 1, pre-dose) and Day 29
description
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
measure
Number of Participants Who Experienced One or More Adverse Events (AEs)
time Frame
Up to approximately 7 months

Full 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.

Source references

references

citation
Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galacteros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor beta ligand trap, improves anemia in beta-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18.
pmid
30337358
type
BACKGROUND