Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia
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|ClinicalTrials.gov Identifier: NCT01712308|
Recruitment Status : Recruiting
First Posted : October 23, 2012
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anemia Myelodysplastic/Myeloproliferative Neoplasm Myelofibrosis||Other: Laboratory Biomarker Analysis Biological: Sotatercept||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 21, 2013|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2021|
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.
Other: Laboratory Biomarker Analysis
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712308
|Contact: Prithviraj Bose, MDfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Prithviraj Bose 713-792-7305|
|Principal Investigator: Prithviraj Bose|
|Principal Investigator:||Prithviraj Bose||M.D. Anderson Cancer Center|