NCT01712308

Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia

A Phase-2, Prospective, Open-Label Study to Determine the Safety and Efficacy of Sotatercept (ACE-011) in Subjects With Myeloproliferative Neoplasm (MPN) -Associated Myelofibrosis and Anemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of and how well sotatercept works in treating patients with myeloproliferative neoplasm-associated myelofibrosis or anemia. Sotatercept may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

The goal of this clinical research study is to learn if sotatercept can help to control MPN-associated myelofibrosis and anemia. The safety of this drug will also be studied. OUTLINE: This is a dose-escalation study. Patients receive sotatercept subcutaneously (SC) once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study. After completion of study treatment, patients are followed up at 1 month.

Conditions

• Anemia
• Myelodysplastic/Myeloproliferative Neoplasm
• Myelofibrosis

Interventions

Type	Name	Description
BIOLOGICAL	Sotatercept	Given SC
DRUG	Ruxolitinib

Timeline

• Start date: 2013-02-21
• Primary completion: 2022-05-24
• Completion: 2022-05-24
• First posted: 2012-10-23
• Last updated: 2023-10-10
• Results posted: 2023-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study