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Trial record 1 of 1 for:    sotatercept (ACE-011) myelofibrosis
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Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01712308
Recruitment Status : Recruiting
First Posted : October 23, 2012
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE October 18, 2012
First Posted Date  ICMJE October 23, 2012
Last Update Posted Date August 12, 2019
Actual Study Start Date  ICMJE February 21, 2013
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Incidence of toxicities [ Time Frame: Up to 28 days after the last dose of study drug ]
    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.
  • Anemia-response [ Time Frame: Up to 84 days ]
    Defined as an increase in hemoglobin level equal to or greater than 1.5 g/L without red blood cell-transfusion OR becoming red blood cell-transfusion-independent in a patient who is red blood cell-transfusion-dependent. Will be based on the intent-to-treat principle.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
Anemia-response [ Time Frame: 15 weeks ]
Primary analysis of response for each dose cohort performed once all 20 patients have been accrued to that dose cohort and treated for at least 5 cycles. Clinical efficacy assessed as anemia response with a target rate of greater than or equal to 30% at either dose level. Anemia response is a composite endpoint defined as an increase in hemoglobin in a subject with anemia or becoming RBC-transfusion-independent in a subject who is RBC-transfusion-dependent.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
Duration of Response [ Time Frame: 15 weeks ]
Duration of response defined as date at which subject's objective status is first noted to be a response, to date progression is documented (if one has occurred) or to date of last follow-up (for those subjects who have not progressed).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia
Official Title  ICMJE 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
Brief 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelofibrosis
Intervention  ICMJE
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Biological: Sotatercept
    Given SC
    Other Names:
    • ACE-011
    • Decoy Activin Receptor ACE-011
Study Arms  ICMJE Experimental: Treatment (sotatercept)
Patients 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.
Interventions:
  • Other: Laboratory Biomarker Analysis
  • Biological: Sotatercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2012)
40
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Prithviraj Bose, MD 713-792-7305 pbose@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01712308
Other Study ID Numbers  ICMJE 2012-0534
NCI-2012-03139 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012-0534 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Prithviraj Bose M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP