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Trial record 6 of 43 for:    synovial | "Dermatofibroma"

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
Sponsor:
Collaborators:
Incyte Corporation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief Summary:
This pilot phase I trial studies how well itacitinib works in treating participants with soft tissue sarcomas that do not respond to treatment and have spread to other parts of the body. 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.

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

Detailed Description:

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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Drug: Itacitinib
Given PO
Other Names:
  • 1334298-90-6
  • 3-Azetidineacetonitrile
  • JAK1 Inhibitor INCB039110
  • INCB039110

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with soft tissue sarcoma of appropriate subtype (reviewed either at our center or a bone and soft tissue pathologist at a major academic center): either leiomyosarcoma (LMS), pleomorphic undifferentiated sarcoma, synovial sarcoma, or myxoid/round cell liposarcoma
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Ability to provide informed consent
  • At least two prior lines of therapy
  • Superficial lesion accessible for multiple biopsies; lesions should be accessible with ultrasound at time of study entry; the tumor being biopsied cannot have been targeted for radiation or have received prior intra-lesional treatment
  • Life expectancy over 6 months in the opinion of treating physician
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 or Karnofksy PS ≥ 60
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
  • Platelet count ≥ 100 × 10^9/L
  • Hemoglobin ≥ 9 g/dL (may have been transfused)
  • Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all subjects
  • Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
  • Negative serum pregnancy test at screening for women of childbearing potential
  • Highly effective contraception for both male and female subjects if the risk of conception exists; * NOTE: women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1% per year; highly effective contraception is required at least 28 days prior, throughout treatment

Exclusion Criteria:

  • Known untreated brain metastasis; treated brain metastasis must have been confirmed stable by at least one scan
  • Subjects may not be receiving other investigational agents
  • Prior anti-cancer therapy within 2 weeks of starting treatment
  • Prior treatment with a drug targeting JAK1, JAK1/2 or STAT3 inhibitor; Food and Drug Administration (FDA) approved small molecule tyrosine kinase inhibitors (TKIs) not specifically designed to target this pathway are okay (e.g. pazopanib, Sutent, sorafenib are okay)
  • Known, active drug or alcohol abuse
  • Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Current oral steroid usage
  • Known inflammatory or autoimmune disease which requires patient to occasionally require high dose oral steroids
  • Patients with known human immunodeficiency virus (HIV) infection must have undetectable viral load and normal CD4 count
  • Inability to swallow food, or significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of the study drug
  • Previous reaction to any component of INCB039110 or known hypersensitivity to the active substance or any of the excipients

Information from the National Library of Medicine

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


Contacts
Contact: Seth Pollack, MD 206-667-6629 spollack@fredhutch.org

Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Seth Pollack         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Incyte Corporation
National Cancer Institute (NCI)
Investigators
Principal Investigator: Seth Pollack Fred Hutchinson Cancer Research Center

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03670069     History of Changes
Other Study ID Numbers: RG1001680
NCI-2018-00615 ( Registry Identifier: CTRP )
9715 ( Other Identifier: FHCRC )
5P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sarcoma, Synovial
Histiocytoma, Malignant Fibrous
Histiocytoma
Sarcoma
Leiomyosarcoma
Liposarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue