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Janus Kinase (JAK) Inhibitor

Itacitinib for Sarcomas

Phase 1
Waitlist Available
Led By Lee Cranmer
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All ongoing toxicities related to prior therapies must be resolved to grade 1 or better (except alopecia)
Subjects must have at least one superficial lesion accessible for multiple biopsies
Must not have
Uncontrolled or concurrent illnesses
Subjects with sarcomas distinct from soft tissue sarcomas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial looks at whether itacitinib can help treat patients with sarcomas that haven't responded to other treatments and have spread to other parts of the body. Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?
Adults (18+) with advanced or metastatic sarcomas that haven't responded to treatment can join this trial. They must have tried at least two systemic therapies for certain sarcoma subtypes, or be treatment-naive for chondrosarcoma. Participants need a life expectancy of 6+ months, manageable side effects from past treatments, and meet specific health criteria like organ function tests.Check my eligibility
What is being tested?
The trial is testing Itacitinib's effectiveness on various sarcoma types resistant to previous treatments. It's a phase I pilot study aiming to see if the drug can halt tumor growth by inhibiting enzymes needed for cell proliferation. Patients will also undergo laboratory biomarker analysis.See study design
What are the potential side effects?
Itacitinib may cause immune system effects, potential liver enzyme changes, gastrointestinal symptoms, blood count variations which could lead to increased infection risk or bleeding problems. Specific side effect profiles will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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All my side effects from previous treatments are mild, except for hair loss.
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I have a visible tumor that can be easily biopsied.
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My sarcoma diagnosis is confirmed and falls into one of the specific subtypes.
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I have had at least two treatments for my condition before.
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I am a man or a woman not pregnant or breastfeeding.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any uncontrolled illnesses.
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My cancer is not a soft tissue sarcoma.
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I have active brain metastases that are not under control or causing symptoms.
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I am taking high dose oral steroids for an autoimmune or inflammatory disease.
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I have an active HIV infection.
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I have been treated with specific inhibitors before.
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I am currently on or recently finished medication for an infection.
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I cannot swallow pills or have a major stomach problem.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in the percentage of cells which are immune inhibitory (CD11B+, CD163+) macrophages from pre-treatment to first post-treatment biopsy
Secondary outcome measures
Clinical benefit rate (complete response [CR]+ partial response [PR]+stable disease [SD])
Incidence of adverse events
Median overall survival
+1 more

Side effects data

From 2020 Phase 3 trial • 439 Patients • NCT03139604
34%
Thrombocytopenia
29%
Anaemia
25%
Oedema peripheral
22%
Hyperglycaemia
21%
Hypertension
20%
Diarrhoea
19%
Hypokalaemia
18%
Platelet count decreased
18%
Nausea
17%
Neutropenia
16%
Cytomegalovirus viraemia
16%
Pyrexia
15%
Cough
14%
Alanine aminotransferase increased
14%
Hypertriglyceridaemia
13%
Dyspnoea
13%
Fatigue
13%
Hypomagnesaemia
13%
Tremor
12%
Cytomegalovirus infection reactivation
12%
Abdominal pain
12%
Blood creatinine increased
12%
Constipation
11%
Decreased appetite
11%
Arthralgia
11%
Aspartate aminotransferase increased
11%
Dizziness
11%
Muscular weakness
11%
Vomiting
10%
Insomnia
9%
Fall
9%
Headache
8%
Upper respiratory tract infection
8%
Dry eye
8%
Dysuria
8%
Anxiety
8%
Back pain
7%
Blood cholesterol increased
7%
Hypotension
7%
Hyponatraemia
7%
Hypophosphataemia
7%
Pain in extremity
7%
Urinary tract infection
7%
Hypocalcaemia
7%
Neutrophil count decreased
7%
Dry mouth
7%
Cytomegalovirus infection
6%
Hypoalbuminaemia
6%
Pruritus
6%
White blood cell count decreased
6%
Asthenia
6%
Blood alkaline phosphatase increased
5%
Acute kidney injury
5%
Pneumonia
5%
Gamma-glutamyltransferase increased
5%
Oral candidiasis
5%
Rash
5%
Weight decreased
5%
Pancytopenia
5%
Dysgeusia
5%
Dyspepsia
5%
Epstein-Barr virus infection reactivation
4%
Hyperkalaemia
4%
Epistaxis
3%
Febrile neutropenia
3%
Oedema
3%
Rhinorrhoea
3%
Dry skin
3%
Leukopenia
3%
Nasopharyngitis
3%
Neuropathy peripheral
3%
Vision blurred
2%
Cystitis haemorrhagic
2%
Syncope
2%
Sepsis
1%
Thrombotic microangiopathy
1%
Graft versus host disease in gastrointestinal tract
1%
Viral haemorrhagic cystitis
1%
Bronchopulmonary aspergillosis
1%
Adenovirus infection
1%
Escherichia sepsis
1%
Failure to thrive
1%
Malignant neoplasm progression
1%
Ophthalmic herpes zoster
1%
Oral herpes
1%
Pulmonary embolism
1%
Septic shock
1%
Pneumonia influenzal
1%
Myopathy
1%
Steroid diabetes
1%
Pseudomonal sepsis
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Itacitinib Plus Corticosteroids
Placebo Plus Corticosteroids
Total

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (itacitinib)Experimental Treatment2 Interventions
Patients receive itacitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~910

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pleomorphic Sarcoma treatments often involve kinase inhibitors like Itacitinib, which block specific enzymes necessary for tumor cell growth and proliferation. These inhibitors target pathways such as the PI3K/AKT/mTOR and MAPK/ERK pathways, which are crucial for cell survival and division. By inhibiting these pathways, the drugs can reduce tumor growth and potentially lead to tumor shrinkage. This is particularly important for Pleomorphic Sarcoma patients as these tumors are typically aggressive and resistant to conventional therapies. Targeted treatments offer a more precise approach, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.
Near Complete Response to Trametinib Treatment in Histiocytic Sarcoma Harboring a Somatic KRAS Mutation.Assessment of Predictive Biomarkers of the Response to Pazopanib Based on an Integrative Analysis of High-grade Soft-tissue Sarcomas: Analysis of a Tumor Sample from a Responder and Patients with Other Soft-tissue Sarcomas.Differences in the responses to pazopanib and the prognoses of soft tissue sarcomas by their histological eligibility for the PALETTE study.

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,302 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
558 Previous Clinical Trials
1,345,558 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
373 Previous Clinical Trials
55,752 Total Patients Enrolled

Media Library

Itacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03670069 — Phase 1
Pleomorphic Sarcoma Research Study Groups: Treatment (itacitinib)
Pleomorphic Sarcoma Clinical Trial 2023: Itacitinib Highlights & Side Effects. Trial Name: NCT03670069 — Phase 1
Itacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03670069 — Phase 1
Pleomorphic Sarcoma Patient Testimony for trial: Trial Name: NCT03670069 — Phase 1
~5 spots leftby Jul 2025