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INCB024360 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects. An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.

Eligible Conditions
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 1 & 2 trial • 444 Patients • NCT02178722
100%
Arthralgia
75%
Pruritus
75%
Nausea
75%
Cough
75%
Fatigue
75%
Diarrhoea
75%
Pain in extremity
75%
Constipation
50%
Dyspnoea
50%
Headache
50%
Rash generalised
50%
Rash
50%
Stomatitis
50%
Depression
50%
Insomnia
50%
Muscle spasms
25%
Procedural pain
25%
Cheilitis
25%
Bronchitis
25%
Jugular vein thrombosis
25%
Anxiety
25%
Chest discomfort
25%
Gastrooesophageal reflux disease
25%
Urinary tract infection
25%
Epistaxis
25%
Glossodynia
25%
Influenza
25%
Xeroderma
25%
Dehydration
25%
Pruritus generalised
25%
Chromaturia
25%
Vitiligo
25%
Amylase increased
25%
Tinnitus
25%
Musculoskeletal pain
25%
Asthenia
25%
Wheezing
25%
Abdominal pain
25%
Asthma
25%
Back pain
25%
Dry mouth
25%
Dry skin
25%
Ear discomfort
25%
Ecchymosis
25%
Fungal infection
25%
Oropharyngeal pain
25%
Skin disorder
25%
Skin lesion
25%
Trismus
25%
Stoma site haemorrhage
25%
Alopecia
25%
Face oedema
25%
Hypoalbuminaemia
25%
Hypothyroidism
25%
Mouth haemorrhage
25%
Rash pruritic
25%
Rhinorrhoea
25%
Taste disorder
25%
Vomiting
25%
Disturbance in attention
25%
Eczema
25%
Erythema
25%
Flatulence
25%
Gastroenteritis
25%
Nasopharyngitis
25%
Neutropenia
25%
Oedema peripheral
25%
Skin ulcer
25%
Wrist fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Epacadostat 25 mg BID
Total
Phase 1: Epacadostat 50 MG BID
Phase 2: Epacadostat 100 MG BID
Phase 1: Epacadostat 300 MG BID
Phase 1: Epacadostat 100 MG BID

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: INCB024360Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epacadostat
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
392 Previous Clinical Trials
63,889 Total Patients Enrolled
Lance Leopold, MDStudy DirectorIncyte Corporation
14 Previous Clinical Trials
1,423 Total Patients Enrolled
~3 spots leftby Dec 2025