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Clinical Trial Summary

This pilot phase I trial studies how well itacitinib works in treating patients with sarcomas that do not respond to treatment (refractory) and have spread to other parts of the body (advanced/metastatic). Itacitinib may cause changes in the immune system and the body's immune response to cancer, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Clinical Trial Description

OUTLINE: Patients receive itacitinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 7 and 30 days, every 12 weeks from baseline for up to 1 year, and then every 6 months thereafter. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Leiomyosarcoma
  • Advanced Myxoid Liposarcoma
  • Advanced Soft Tissue Sarcoma
  • Advanced Synovial Sarcoma
  • Advanced Undifferentiated Pleomorphic Sarcoma
  • Chondrosarcoma
  • Histiocytoma, Malignant Fibrous
  • Leiomyosarcoma
  • Liposarcoma
  • Liposarcoma, Myxoid
  • Metastatic Chondrosarcoma
  • Metastatic Leiomyosarcoma
  • Metastatic Myxoid Liposarcoma
  • Metastatic Round Cell Liposarcoma
  • Metastatic Soft Tissue Sarcoma
  • Metastatic Synovial Sarcoma
  • Metastatic Undifferentiated Pleomorphic Sarcoma
  • Refractory Leiomyosarcoma
  • Refractory Myxoid Liposarcoma
  • Refractory Round Cell Liposarcoma
  • Refractory Soft Tissue Sarcoma
  • Refractory Synovial Sarcoma
  • Refractory Undifferentiated Pleomorphic Sarcoma
  • Sarcoma
  • Sarcoma, Synovial

NCT number NCT03670069
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact Roxanne Moore
Phone 206-606-6425
Email [email protected]
Status Recruiting
Phase Phase 1
Start date September 30, 2019
Completion date June 1, 2024

See also
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