Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas

  • End date
    Jun 1, 2024
  • participants needed
  • sponsor
    Fred Hutchinson Cancer Research Center
Updated on 7 March 2022


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 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.



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.

Condition 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
Treatment laboratory biomarker analysis, itacitinib
Clinical Study IdentifierNCT03670069
SponsorFred Hutchinson Cancer Research Center
Last Modified on7 March 2022


Yes No Not Sure

Inclusion Criteria

Must have a histologically confirmed diagnosis of sarcoma with one of the following
Cohort 1: Leiomyosarcoma
Cohort 2: Undifferentiated pleiomorphic sarcoma
Cohort 3: Synovial sarcoma or myxoid/round cell liposarcoma
Subjects must have received at least two prior lines of systemic therapy
All ongoing toxicities related to prior therapies must be resolved to grade 1 or better (except alopecia)
Cohort 4: Chondrosarcoma (all subtypes of chondrosarcoma are allowed)
Subjects must have one or more measurable lesions, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 assessed by computed tomography (CT) or magnetic resonance imaging (MRI)
Subjects must have at least one superficial lesion accessible for multiple biopsies; the tumor being biopsied cannot have been previously targeted for radiation therapy or have previously received intra-lesional treatment
NOTE: Superficial lesions previously targeted with radiation therapy that have demonstrated significant new growth via radiological imaging may be targeted for biopsy, with sponsor-investigator approval
Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range mg/dL
Aspartate aminotransferase (AST) =< 2.5 x ULN and alanine aminotransferase (ALT) levels =< 2.5 x ULN
Alkaline phosphatase < 2.5 x ULN
Serum creatinine =< 1.5 x ULN
Calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault formula may be included
Platelet count >= 100 x 10^9/L; transfusion is permitted as clinically indicated
Absolute neutrophil count (ANC) >= 1.5 × 10^9/L
Hemoglobin >= 9 g/dL
Transfusion is permitted as clinically indicated
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofksy performance status >= 60
Male or non-pregnant and non-breast feeding female
Subjects must have a life expectancy >= 6 months, as determined by the treating
Females of child-bearing potential must agree to use highly effective contraception without interruption from initiation of therapy and while on study medication and have a negative serum pregnancy test (beta - human chorionic gonadotropin [hCG]) result at screening and agree to ongoing pregnancy testing during the course of the study, and at the end of study treatment; a highly effective method of contraception is defined as one that results in a low failure rate (that is, < 1% per year), when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner
Male subjects must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study
Ability to understand and sign informed consent document
Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures

Exclusion Criteria

Known active, uncontrolled, or symptomatic central nervous system (CNS) metastases; a subject with controlled and asymptomatic CNS metastases may participate in this study; as such, the subject must have completed any prior treatment for CNS metastases >= 28 days (including radiotherapy and/or surgery) prior to the start of treatment in this study and should not be receiving chronic corticosteroid therapy for CNS metastases; subjects with known CNS metastases must be confirmed radiographically stable by at least one imaging study, at least 28 days from last treatment
Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 2 weeks of enrollment
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, sunitinib, sorafenib)
Known, active drug or alcohol abuse
Pregnant or lactating females
Active or recent infection requiring systemic anti-infective treatment that was completed =<14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory infection)
Uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Oral steroid usage within =< 14 days prior to enrollment
Known inflammatory or autoimmune disease which requires patient to occasionally require high dose oral steroids
Subjects with known, active human immunodeficiency virus (HIV) infection (subjects with undetectable viral load and normal CD4+ 1-cell count are permitted)
Inability to swallow food or tablets, 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 itacitinib or known hypersensitivity to the active substance or any of the excipients
Subjects with a sarcoma which has other, defined treatments or biology distinctly different from those of soft tissue sarcomas in general; including, but not limited to, Ewing's sarcoma, rhabdomyosarcoma, gastrointestinal stromal tumors, Kaposi's sarcoma, Wilm's tumor
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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