Persistent low enrollment made study continuation no longer feasible
An Open-Label Randomized, Phase 2A, Dose-Ranging Study of Sotatercept (ACE-011) for Chemotherapy-Induced Anemia in Subjects With Advanced or Metastatic Solid Tumors Treated With Platinum-Based Chemotherapeutic Regimens
Sponsor study identifier
Secondary identifiers
OTHER · Celgene
EUDRACT_NUMBER
interventional
26
0 countries
N/A
Study Start
March 25, 2011
Actual (reported)Primary Completion
September 21, 2012
Actual (reported)Study Completion
September 21, 2012
Actual (reported)The purpose of this study was to determine an effective and safe dose of sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia (CIA) in participants with metastatic non-small cell lung cancer (NSCLC) who are being treated with first-line platinum based chemotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 21, 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 17, 2010
Actual (reported)January 27, 2011
Actual (reported)March 25, 2011
Actual (reported)September 21, 2012
Actual (reported)September 21, 2012
Actual (reported)October 31, 2023
Actual (reported)Number of Participants Who Experienced a Hematopoietic Response
A hematopoietic response was defined as an increase in a participant's hemoglobin (Hgb) of ≥1.0 g/dL above the study baseline value for 4 consecutive weeks, in the absence of red blood cell transfusion and/or erythropoiesis-stimulating agents.
Up to Day 28
Number of Participants Who Experienced One or More Adverse Events (AEs)
Up to approximately 6 months
Time to Progression (TTP)
Up to 6 months
Participants will receive sotatercept 15 mg by subcutaneous (SC) injection once every 42 days, up to four doses.
Participants will receive sotatercept 30 mg by SC injection once every 42 days, up to four doses.
Sotatercept 15 mg SC injection once every 42 days, up to four doses
Sotatercept 30 mg SC injection once every 42 days, up to four doses
Raftopoulos H, Laadem A, Hesketh PJ, Goldschmidt J, Gabrail N, Osborne C, Ali M, Sherman ML, Wang D, Glaspy JA, Puccio-Pick M, Zou J, Crawford J. Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies. Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 2015 Sep 14.
Medical Director
Merck Sharp & Dohme LLC
26 participants (actual enrollment reported by the registry).
First Submitted
December 17, 2010
First Posted
January 27, 2011
Study Start
March 25, 2011
Actual (reported)Progression Free Survival (PFS)
Up to 12 months
Overall Survival (OS)
Up to 24 months
Overall Response Rate (ORR)
Up to 12 months
Contact the study team to confirm eligibility.
Primary Completion
September 21, 2012
Actual (reported)Study Completion
September 21, 2012
Actual (reported)Last Updated
August 29, 2024
Results First Posted
October 31, 2023
Record last verified: 2024-07
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Source: ClinicalTrials.gov.
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