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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 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 Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 30, 2019
Completion date March 31, 2024

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