What side effects are associated with this type of intervention?

Common treatments for pleomorphic sarcoma, particularly those involving kinase inhibitors like Itacitinib, often include drugs such as pazopanib and sunitinib. Known side effects of these treatments can include hypertension, fatigue, diarrhea, and hand-foot syndrome. Additionally, pazopanib has been associated with liver toxicity, while sunitinib can cause thyroid dysfunction and cardiovascular issues. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Pleomorphic Sarcoma in the provided context. However, kinase inhibitors like Itacitinib, which block enzymes needed for cell growth, are a class of drugs being explored for various cancers. For instance, the context mentions the use of farnesyltransferase inhibitors and other kinase inhibitors in different types of cancers, indicating a broader interest in targeting kinase pathways for cancer treatment.

What other types of research exist?

Promising alternatives to Itacitinib for Pleomorphic Sarcoma patients include regorafenib, cabozantinib, sorafenib, and lenvatinib. These agents have shown some activity in treating sarcomas and may be considered as potential treatment options.

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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

No Placebo-Only Group

Summary

This trial is testing itacitinib, a daily oral medication, in patients with advanced sarcomas that haven't responded to other treatments. Itacitinib works by blocking enzymes that cancer cells need to grow. It has been studied for its effectiveness and safety in treating inflammatory and autoimmune diseases, as well as in combination with other treatments for advanced solid tumors.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in the percentage of cells which are immune inhibitory (CD11B+, CD163+) macrophages from pre-treatment to first post-treatment biopsy

Secondary study objectives

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

Fall

Headache

Upper respiratory tract infection

Dry eye

Dysuria

Anxiety

Back pain

Blood cholesterol increased

Hypotension

Hyponatraemia

Hypophosphataemia

Pain in extremity

Urinary tract infection

Hypocalcaemia

Neutrophil count decreased

Dry mouth

Cytomegalovirus infection

Hypoalbuminaemia

Pruritus

White blood cell count decreased

Asthenia

Blood alkaline phosphatase increased

Acute kidney injury

Pneumonia

Gamma-glutamyltransferase increased

Oral candidiasis

Rash

Weight decreased

Pancytopenia

Dysgeusia

Dyspepsia

Epstein-Barr virus infection reactivation

Hyperkalaemia

Epistaxis

Febrile neutropenia

Oedema

Rhinorrhoea

Dry skin

Leukopenia

Nasopharyngitis

Neuropathy peripheral

Vision blurred

Cystitis haemorrhagic

Syncope

Sepsis

Graft versus host disease in gastrointestinal tract

Thrombotic microangiopathy

Viral haemorrhagic cystitis

Bronchopulmonary aspergillosis

Adenovirus infection

Escherichia sepsis

Failure to thrive

Malignant neoplasm progression

Ophthalmic herpes zoster

Oral herpes

Pulmonary embolism

Septic shock

Pneumonia influenzal

Myopathy

Steroid diabetes

Pseudomonal sepsis

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Itacitinib Plus Corticosteroids

Placebo Plus Corticosteroids

Total

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~980

0 / 14Eligibility criteria met

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.