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

NCT01190644 | Terminated Phase 2 Results

• 2 other identifiers: 7962-016ACE-011-ST-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Solid Tumors

Keywords

Red Blood Cell Mass; Plasma Volume; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (7)

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

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

• Change From Baseline in Absolute Reticulocyte Count

  Baseline (Day 1, pre-dose) and Day 211

• Change From Baseline in Erythropoietin Levels

  Baseline (Day 1, pre-dose) and Day 211

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

  Baseline (Day 1, pre-dose) and Day 29

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

  Baseline (Day 1, pre-dose) and Day 29

Study Arms (1)

Sotatercept

EXPERIMENTAL

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

Drug: Sotatercept

Interventions

Sotatercept DRUG

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

Also known as: ACE 011

Sotatercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

Saint Agnes Healthcare

Baltimore, Maryland, 21229, United States

Location

Weinberg Cancer Institution at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Pennsylvania Oncology

Philadelphia, Pennsylvania, 19106, United States

Location

Related Publications (1)

• 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 BACKGROUND

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

ACE-011

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: August 27, 2010
• Study Start: June 1, 2010
• Primary Completion: September 18, 2012
• Study Completion: October 29, 2012
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (3)