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Kinase Inhibitor
Pemigatinib for Advanced Cancer
Phase 2
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
Currently have no evidence of progressive disease, as determined by the investigator, following treatment with pemigatinib as monotherapy or combination therapy
Be older than 18 years old
Must not have
Able to access pemigatinib commercially or outside of a clinical trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to at least 30 days after the last dose of study treatment or until toxicities resolve, return to baseline, or are deemed irreversible, whichever was longer (up to 1010 days)
Awards & highlights
Summary
This trial is focused on the long-term safety and continued use of pemigatinib in patients with advanced cancers who have already been treated with this medication. Pemigatinib helps stop cancer cells from growing by blocking essential proteins.
Who is the study for?
This trial is for patients already in a study using Pemigatinib for advanced cancers, who are seeing benefits and can follow the study plan. They must not have worsening disease and agree to prevent pregnancy or fathering children during the trial.
What is being tested?
The focus is on continuing to provide Pemigatinib, alone or with other drugs like Pembrolizumab or Retifanlimab, to see how safe and tolerable it is for those already taking it in an ongoing Incyte-sponsored study.
What are the potential side effects?
Possible side effects include reactions at the injection site, fatigue, nausea, liver issues (like increased enzymes), blood count changes that could lead to infections or bleeding problems, rash, and muscle pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer hasn't worsened after treatment with pemigatinib alone or with other drugs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can get pemigatinib outside of a clinical trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to at least 30 days after the last dose of study treatment or until toxicities resolve, return to baseline, or are deemed irreversible, whichever was longer (up to 1010 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to at least 30 days after the last dose of study treatment or until toxicities resolve, return to baseline, or are deemed irreversible, whichever was longer (up to 1010 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Side effects data
From 2022 Phase 2 trial • 147 Patients • NCT0292437659%
Alopecia
56%
Hyperphosphataemia
54%
Diarrhoea
46%
Fatigue
43%
Stomatitis
43%
Constipation
42%
Nausea
42%
Dysgeusia
39%
Dry mouth
35%
Dry eye
34%
Arthralgia
32%
Vomiting
31%
Decreased appetite
28%
Dry skin
26%
Hypophosphataemia
25%
Back pain
24%
Pain in extremity
21%
Palmar-plantar erythrodysaesthesia syndrome
20%
Abdominal pain
19%
Headache
19%
Urinary tract infection
19%
Weight decreased
18%
Dizziness
18%
Epistaxis
15%
Oedema peripheral
15%
Hypercalcaemia
15%
Anaemia
15%
Dehydration
14%
Myalgia
14%
Asthenia
13%
Dyspepsia
12%
Gastrooesophageal reflux disease
12%
Insomnia
12%
Nasal dryness
12%
Pruritus
12%
Onychomadesis
11%
Blood alkaline phosphatase increased
11%
Rash
11%
Nail discolouration
11%
Alanine aminotransferase increased
10%
Muscle spasms
10%
Pyrexia
10%
Abdominal pain upper
10%
Nail dystrophy
10%
Oropharyngeal pain
10%
Trichiasis
9%
Dyspnoea
9%
Vitamin D deficiency
9%
Onycholysis
9%
Cough
8%
Abdominal distension
8%
Hyperbilirubinaemia
8%
Hypertension
8%
Hypokalaemia
8%
Paronychia
8%
Onychoclasis
8%
Blood creatinine increased
8%
Aspartate aminotransferase increased
7%
Growth of eyelashes
7%
Fall
7%
Punctate keratitis
7%
Erythema
7%
Nasal congestion
7%
Platelet count decreased
6%
Conjunctivitis
6%
Lacrimation increased
6%
Nail disorder
6%
Nasopharyngitis
6%
Neuropathy peripheral
6%
Skin exfoliation
6%
Taste disorder
6%
Upper respiratory tract infection
6%
Cataract
6%
Eye pain
6%
Chills
6%
Blood bilirubin increased
6%
Depression
6%
Hyponatraemia
6%
Ocular hyperaemia
6%
Influenza like illness
5%
Dysphagia
5%
Vitreous floaters
5%
Cystitis
5%
Cholangitis
5%
Flank pain
5%
Hypotension
5%
Acute kidney injury
5%
Muscular weakness
5%
Neck pain
5%
Oral candidiasis
4%
Hyperuricaemia
4%
Pain
4%
Weight increased
4%
Ascites
4%
Skin fissures
4%
Lymphocyte count decreased
4%
Keratitis
3%
Breast pain
3%
Activated partial thromboplastin time prolonged
3%
Dyspnoea exertional
3%
Tinnitus
3%
Blood parathyroid hormone decreased
3%
Pollakiuria
3%
Bronchitis
3%
Cholangitis infective
3%
Non-cardiac chest pain
2%
Decubitus ulcer
2%
Sepsis
2%
Blood 1,25-dihydroxycholecalciferol increased
2%
Electrocardiogram QT prolonged
2%
Hypoalbuminaemia
2%
Failure to thrive
2%
Bacteraemia
2%
Hypocalcaemia
2%
Palpitations
2%
Pharyngitis
2%
Rash maculo-papular
2%
Tachycardia
2%
Trichomegaly
2%
Dysuria
2%
Hyperglycaemia
2%
Dysphonia
2%
Device occlusion
2%
Small intestinal obstruction
2%
Blood 1,25-dihydroxycholecalciferol decreased
2%
Chronic kidney disease
2%
Biliary obstruction
2%
Pleural effusion
2%
Pneumonia
2%
Hypercholesterolaemia
1%
Prostate cancer
1%
Skin infection
1%
Retinal detachment
1%
Septic shock
1%
Thrombosis
1%
Biliary tract infection
1%
Complication associated with device
1%
Enterobacter bacteraemia
1%
Intestinal obstruction
1%
Hyperkalaemia
1%
Jaundice
1%
Kidney infection
1%
Oesophageal varices haemorrhage
1%
Micturition urgency
1%
Seizure
1%
Pseudomonal bacteraemia
1%
Varices oesophageal
1%
Oral herpes
1%
Clostridium difficile infection
1%
Device leakage
1%
Gynaecomastia
1%
Somnolence
1%
Catheter site infection
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Hydronephrosis
1%
Optic ischaemic neuropathy
1%
Pneumonitis
1%
Transaminases increased
1%
C-reactive protein increased
1%
Cancer pain
1%
Candida infection
1%
Confusional state
1%
Herpes zoster
1%
Musculoskeletal pain
1%
Psoriasis
1%
Blood chloride decreased
1%
Cerebrovascular accident
1%
Malignant biliary obstruction
1%
Melaena
1%
Paraplegia
1%
Pneumonia aspiration
1%
Pneumonia pneumococcal
1%
Syncope
1%
Haemorrhoids
1%
Sinus pain
1%
Urinary tract pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A: FGFR2 Rearrangements or Fusions
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Cohort C: Negative for FGF/FGFR Alterations
Other
Total
Trial Design
3Treatment groups
Experimental Treatment
Group I: Study Treatment 3: Pemigatininb + PembrolizumabExperimental Treatment2 Interventions
Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions.
Group II: Study Treatment 2: Pemigatininb+ RetifanlimabExperimental Treatment2 Interventions
Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks
Group III: Study Treatment 1: Pemigatinib (INCB054828)Experimental Treatment1 Intervention
Pemigatinib will be taken orally once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2850
Pemigatinib
2022
Completed Phase 2
~250
Retifanlimab
2018
Completed Phase 2
~320
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
Cancer treatments often target specific molecular pathways that are crucial for tumor growth and survival. FGFR inhibitors, such as Pemigatinib, block the fibroblast growth factor receptor (FGFR) pathway, which is involved in cell proliferation and survival.
By inhibiting this pathway, these drugs can reduce tumor growth and potentially lead to tumor regression. This targeted approach is important for cancer patients because it can provide more effective and personalized treatment options with potentially fewer side effects compared to traditional chemotherapy.
Understanding the specific mechanisms of action helps in selecting the most appropriate therapy based on the genetic profile of the tumor, thereby improving treatment outcomes.
The Mechanism of Action of Regorafenib in Colorectal Cancer: A Guide for the Community Physician.
The Mechanism of Action of Regorafenib in Colorectal Cancer: A Guide for the Community Physician.
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
386 Previous Clinical Trials
57,843 Total Patients Enrolled
Peter LangmuirStudy DirectorIncyte Corporation
2 Previous Clinical Trials
82 Total Patients Enrolled
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