Clinical Trials /

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

NCT01712308

Description:

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.

Related Conditions:
  • Myelofibrosis
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 2012-0534
  • SECONDARY ID: NCI-2012-03139
  • SECONDARY ID: 2012-0534
  • SECONDARY ID: P30CA016672
  • NCT ID: NCT01712308

Conditions

  • Anemia
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelofibrosis

Interventions

DrugSynonymsArms
SotaterceptACE-011, Decoy Activin Receptor ACE-011Treatment (sotatercept)

Purpose

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

      PRIMARY OBJECTIVES:

      I. Determine safety and efficacy of sotatercept as therapy for persons with
      myeloproliferative neoplasm (MPN)-associated myelofibrosis and anemia.

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (sotatercept)ExperimentalPatients receive sotatercept 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.
  • Sotatercept

Eligibility Criteria

        Inclusion Criteria:

          -  MPN-associated myelofibrosis

          -  Anemic patient OR red blood cell (RBC)-transfusion-dependent patient

          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and
             aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])
             equal to or less than 2.5 x upper limit of normal (ULN), or equal to or less than 4 x
             ULN (if upon judgment of the treating physician, it is believed to be due to
             extramedullary hematopoiesis [EMH] related to myelofibrosis [MF])

          -  Direct bilirubin equal to or less than 1.5 x ULN; or equal to or less than 2 x ULN (if
             upon judgment of the treating physician, it is believed to be due to extramedullary
             hematopoiesis related to MF)

          -  Creatinine clearance equal to or more than 50 mL/min

          -  Treatment-related toxicities from prior therapies must have resolved to grade equal to
             or less than 1

          -  Women of childbearing potential and men must agree to using medically approved (i.e.,
             mechanical or pharmacological) contraceptive measure for at least 112 days following
             the last dose of sotatercept (ACE-011); males must agree to use a latex condom or
             non-latex condom NOT made of natural (animal) membrane during any sexual contact with
             females of childbearing potential or a pregnant female while participating in the
             study and for at least 112 days following the last dose of sotatercept (ACE-011), even
             if he has a vasectomy

          -  For cohort of patients that are already on ruxolitinib therapy: on therapy with
             ruxolitinib for at least for 6 months, and on stable dose for last 2 months, before
             starting therapy with sotatercept

        Exclusion Criteria:

          -  Serious medical condition or psychiatric illness that would prevent, (as judged by the
             treating physician) the subject from signing the informed consent form or any
             condition including the presence of laboratory abnormalities, which places the subject
             at unacceptable risk if he/she were to participate in the study or confounds the
             ability to interpret data from the study

          -  Pregnant or lactating female

          -  Known positive for human immunodeficiency virus-1 (HIV-1), or active infection with
             hepatitis-B or -C

          -  Use of any MPN-associated myelofibrosis-directed therapy within 2 weeks prior to study
             day 1 (other than ruxolitinib at a stable dose for patients in the combination cohort
             as stated in inclusion criteria)

          -  Symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia

          -  Prior sotatercept

          -  Major surgery within 4 weeks prior to day 1

          -  Severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins
             or excipients in the investigational product

          -  Uncontrolled hypertension (systolic blood pressure [SBP] equal to or more than 140 or
             diastolic blood pressure [DBP] equal to or more than 90)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of toxicities
Time Frame:Up to 28 days after the last dose of study drug
Safety Issue:
Description:Severity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity is defined as an adverse event and classified as possibly, probably, or definitely related to study drug. Such adverse events will be recorded by the principal investigator in a database. The maximum grade for each type of toxicity will be recorded for each patient, including start/stop dates, and frequency tables for each group will be reviewed to determine toxicity patterns.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Last Updated

August 8, 2019