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.
Eligible Conditions
- Refractory Undifferentiated Pleomorphic Sarcoma
- Leiomyosarcoma
- Metastatic Chondrosarcoma
- Soft Tissue Sarcoma
- Advanced Undifferentiated Pleomorphic Sarcoma
- Metastatic Synovial Sarcoma
- Metastatic Soft Tissue Sarcoma
- Metastatic Myxoid Liposarcoma
- Myxoid Liposarcoma
- Refractory Round Cell Liposarcoma
- Refractory Soft Tissue Sarcomas
- Metastatic Undifferentiated Pleomorphic Sarcoma
- Refractory Leiomyosarcoma
- Metastatic Leiomyosarcoma
- Metastatic Round Cell Liposarcoma
- Refractory Synovial Sarcoma
- Advanced Synovial Sarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to 2 years
At 12 months
Median overall survival
At 12 weeks
Clinical benefit rate (complete response [CR]+ partial response [PR]+stable disease [SD])
At 6 months
Progression-free survival rate
Year 2
Difference in the percentage of cells which are immune inhibitory (CD11B+, CD163+) macrophages from pre-treatment to first post-treatment biopsy
Up to 2 years
Incidence of adverse events
Trial Safety
Safety Progress
Side Effects for
Total
33%Thrombocytopenia
27%Anaemia
25%Oedema peripheral
23%Hyperglycaemia
20%Diarrhoea
18%Hypertension
18%Neutropenia
17%Hypokalaemia
17%Cough
16%Nausea
15%Pyrexia
15%Fatigue
14%Cytomegalovirus viraemia
14%Platelet count decreased
13%Hypertriglyceridaemia
12%Alanine aminotransferase increased
12%Cytomegalovirus infection reactivation
12%Abdominal pain
12%Headache
11%Constipation
11%Vomiting
11%Decreased appetite
11%Insomnia
11%Hypomagnesaemia
11%Tremor
10%Blood creatinine increased
10%Muscular weakness
10%Arthralgia
10%Dyspnoea
10%Fall
9%Back pain
9%Dizziness
9%Hyponatraemia
8%Dry eye
8%Hypoalbuminaemia
8%Hypocalcaemia
8%Upper respiratory tract infection
8%Aspartate aminotransferase increased
7%Asthenia
7%Urinary tract infection
7%Anxiety
7%Pruritus
7%Dry mouth
7%Acute kidney injury
6%Pain in extremity
6%Dysuria
6%Hypophosphataemia
6%Neutrophil count decreased
6%Pneumonia
6%Blood cholesterol increased
6%Blood alkaline phosphatase increased
6%Cytomegalovirus infection
6%Hyperkalaemia
6%Hypotension
5%Dyspepsia
5%Oral candidiasis
5%Oedema
5%White blood cell count decreased
5%Rhinorrhoea
5%Epistaxis
4%Nasopharyngitis
4%Epstein-Barr virus infection reactivation
4%Neuropathy peripheral
4%Vision blurred
4%Weight decreased
4%Gamma-glutamyltransferase increased
4%Dry skin
4%Leukopenia
4%Pancytopenia
3%Sepsis
3%Rash
3%Febrile neutropenia
3%Dysgeusia
2%Septic shock
2%Graft versus host disease in gastrointestinal tract
2%Respiratory failure
1%Dehydration
1%Bronchitis
1%Bacteraemia
1%Bronchopulmonary aspergillosis
1%Confusional state
1%Failure to thrive
1%Graft versus host disease
1%Malignant neoplasm progression
1%Myopathy
1%Pulmonary embolism
1%Adenovirus infection
1%Staphylococcal bacteraemia
1%Thrombotic microangiopathy
1%Viral haemorrhagic cystitis
1%Enterococcal bacteraemia
1%Escherichia sepsis
1%Influenza
1%Multiple organ dysfunction syndrome
1%Presyncope
1%Syncope
1%Acute graft versus host disease
1%Cystitis haemorrhagic
Trial Design
1 Treatment Group
Treatment (itacitinib)
1 of 1
Experimental Treatment
28 Total Participants · 1 Treatment Group
Primary Treatment: Itacitinib · No Placebo Group · Phase 1
Treatment (itacitinib)Experimental Group · 2 Interventions: Itacitinib, Laboratory Biomarker Analysis · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,113 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
530 Previous Clinical Trials
1,303,789 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
315 Previous Clinical Trials
46,492 Total Patients Enrolled
Michael WagnerPrincipal InvestigatorFred Hutchinson Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a histologic diagnosis of leiomyosarcoma.
Subjects must have received at least two prior lines of systemic therapy.
Subjects must have 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.
You have previously had a superficial lesion that has demonstrated significant new growth via radiological imaging
You have a diagnosis of undifferentiated pleiomorphic sarcoma.
You have synovial sarcoma or myxoid/round cell liposarcoma.
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Conditions
Cancer Related
Treatments