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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 Participants With Solid Tumors

NCT ID: NCT01190644

Last Updated: 2023-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-01

Study Completion Date

2012-10-29

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sotatercept

Participants will receive a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85.

Group Type EXPERIMENTAL

Sotatercept

Intervention Type DRUG

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

Interventions

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Sotatercept

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

Intervention Type DRUG

Other Intervention Names

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ACE 011

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Saint Agnes Healthcare

Baltimore, Maryland, United States

Site Status

Weinberg Cancer Institution at Franklin Square

Baltimore, Maryland, United States

Site Status

Pennsylvania Oncology

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30337358 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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ACE-011-ST-001

Identifier Type: OTHER

Identifier Source: secondary_id

7962-016

Identifier Type: -

Identifier Source: org_study_id