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
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|