Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT03670069
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Leiomyosarcoma
  • Advanced Myxoid Liposarcoma
  • Advanced Soft Tissue Sarcoma
  • Advanced Synovial Sarcoma
  • Advanced Undifferentiated Pleomorphic Sarcoma
  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Sep 30, 2019
Status verified
May 2024
Primary completion
Mar 4, 2023
Completion
May 6, 2024

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (itacitinib)
    Patients receive itacitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Difference in the percentage of cells which are immune inhibitory (CD11B+, CD163+) macrophages from pre-treatment to first post-treatment biopsy [ Time Frame: From baseline to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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