Trials / Terminated
TerminatedNCT03670069
Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas
A Pilot Study Examining the Impact of the Jak1 Inhibitor Itacitinib on the Sarcoma Tumor Immune Microenvironment
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Metastatic Leiomyosarcoma
- Metastatic Synovial Sarcoma
- Metastatic Undifferentiated Pleomorphic Sarcoma
- Advanced Myxoid Liposarcoma
- Advanced Soft Tissue Sarcoma
- Metastatic Myxoid Liposarcoma
- Metastatic Round Cell Liposarcoma
- Metastatic Soft Tissue Sarcoma
- Refractory Leiomyosarcoma
- Refractory Myxoid Liposarcoma
- Refractory Round Cell Liposarcoma
- Refractory Soft Tissue Sarcoma
- Refractory Synovial Sarcoma
- Refractory Undifferentiated Pleomorphic Sarcoma
- Advanced Leiomyosarcoma
- Advanced Synovial Sarcoma
- Advanced Undifferentiated Pleomorphic Sarcoma
- Metastatic Chondrosarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Itacitinib | Given PO |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2019-09-30
- Primary completion
- 2023-03-04
- Completion
- 2024-05-06
- First posted
- 2018-09-13
- Last updated
- 2024-05-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03670069. Inclusion in this directory is not an endorsement.