Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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 belowSelect...
All my side effects from previous treatments are mild, except for hair loss.
Select...
I have a visible tumor that can be easily biopsied.
Select...
My sarcoma diagnosis is confirmed and falls into one of the specific subtypes.
Select...
I have had at least two treatments for my condition before.
Select...
I am a man or a woman not pregnant or breastfeeding.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreSide effects data
From 2020 Phase 3 trial • 439 Patients • NCT0313960434%
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
Placebo Plus Corticosteroids
Itacitinib 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
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,218 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,241 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- All my side effects from previous treatments are mild, except for hair loss.I have a visible tumor that can be easily biopsied.I have a lesion that grew after radiation, pending approval for biopsy.My sarcoma diagnosis is confirmed and falls into one of the specific subtypes.I have had at least two treatments for my condition before.I am a man or a woman not pregnant or breastfeeding.I am 18 years old or older.I do not have any uncontrolled illnesses.My cancer is not a soft tissue sarcoma.I have active brain metastases that are not under control or causing symptoms.I am taking high dose oral steroids for an autoimmune or inflammatory disease.I have an active HIV infection.I have been treated with specific inhibitors before.I have recently received treatment for cancer.I am currently on or recently finished medication for an infection.I have recently taken oral steroids.I cannot swallow pills or have a major stomach problem.I can receive blood transfusions if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (itacitinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pleomorphic Sarcoma Patient Testimony for trial: Trial Name: NCT03670069 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots remaining for this research project?
"That is accurate. The listing on clinicaltrials.gov notes that the trial is open for 28 patients at a single site. The listing was created on September 30th, 2019 and was last updated on October 13th, 2020."
Answered by AI
Does the medical literature contain other research on Itacitinib?
"Currently, there are 23 on-going clinical trials investigating Itacitinib with 1 trials in the final Phase 3. The majority of these are taking place in Houston, Texas, but Itacitinib trials are being conducted at 380 locations globally."
Answered by AI
What is the most pressing concern with Itacitinib?
"Since this is a Phase 1 trial, there is limited data supporting both the safety and efficacy of Itacitinib. Our team has estimated a score of 1."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
Fred Hutch/University of Washington Cancer Consortium
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
my husband received radiation in June but Kaiser says they cant remove tumor and were looking for alternative treatment or second opinion.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger