Itacitinib in Treating Participants With Refractory Metastatic/Advanced Soft Tissue Sarcomas
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|ClinicalTrials.gov Identifier: NCT03670069|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Leiomyosarcoma Metastatic Synovial Sarcoma Metastatic Undifferentiated Pleomorphic Sarcoma Round Cell Liposarcoma||Drug: Itacitinib Other: Laboratory Biomarker Analysis||Phase 1|
Participants receive itacitinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up between 7-30 days and then every 12 weeks for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Examining the Impact of the Jak1 Inhibitor INCB39110 On the Sarcoma Tumor Immune Microenvironment|
|Estimated Study Start Date :||November 12, 2018|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Treatment (itacitinib)
Participants receive itacitinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable. Laboratory Biomarker Analysis will be performed.
Other: Laboratory Biomarker Analysis
- Difference in the percentage of cells which are immune inhibitory (CD11B+, CD163+) macrophages from pre-treatment to first post-treatment biopsy [ Time Frame: 2 Years ]Evaluation of the change in percentages of cells against the null hypothesis of no difference will be performed using a 1-sided t-test at the 0.05 level.
- Progression-free survival (PFS) [ Time Frame: Up to 2 Years ]Estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the method of Brookmeyer-Crowley
- Incidence of adverse events [ Time Frame: Up to 2 years ]The frequency and severity of toxicities will be evaluated by proportions and associated 95% confidence interval; (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03)
- Clinical Benefit Rate [ Time Frame: At 12 weeks ]Complete Response [CR]+ Partial Response [PR]+Stable Disease [SD]); CR and PR will be defined as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Overall survival [ Time Frame: Up to 2 years ]Distributions and percentages at landmark times for time to event outcomes will be estimated using the method of Kaplan-Meier
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670069
|Contact: Seth Pollack, MDemail@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Seth Pollack|
|Principal Investigator:||Seth Pollack||Fred Hutchinson Cancer Research Center|