Clinical Trials Logo

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
  Status Clinical Trial Phase
Recruiting NCT03793361 - Phase II Study of Regorafenib as Maintenance Therapy Phase 2
Active, not recruiting NCT03009201 - Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery Phase 1
Withdrawn NCT03397186 - Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma Phase 2
Active, not recruiting NCT02500797 - Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery Phase 2
Recruiting NCT03965234 - Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Soft Tissue or Bone Sarcoma Metastatic to the Lungs Phase 1/Phase 2
Recruiting NCT04028063 - Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas Phase 2
Recruiting NCT04200443 - Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma Phase 2
Active, not recruiting NCT01514188 - Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma Phase 2
Completed NCT01574716 - Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation Phase 2
Recruiting NCT03138161 - SAINT:Trabectedin, Ipilimumab and Nivolumab as First Line Treatment for Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Recruiting NCT03660930 - Nanoparticle Albumin-Bound Rapamycin and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas Phase 1/Phase 2