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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last dose
Awards & highlights

Study Summary

This trial looks at the safety and tolerability of pemigatinib in patients with advanced malignancies who have participated in a previous study.

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.Check my eligibility
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.See study design
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 below
Select...
My cancer hasn't worsened after treatment with pemigatinib alone or with other drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Treatment Emergent Adverse Events (TEAEs)

Side effects data

From 2022 Phase 2 trial • 147 Patients • NCT02924376
59%
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%
Insomnia
12%
Nasal dryness
12%
Gastrooesophageal reflux disease
12%
Pruritus
12%
Onychomadesis
11%
Rash
11%
Blood alkaline phosphatase increased
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%
Hyperbilirubinaemia
8%
Hypertension
8%
Abdominal distension
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%
Lacrimation increased
6%
Conjunctivitis
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%
Weight increased
4%
Pain
4%
Ascites
4%
Skin fissures
4%
Lymphocyte count decreased
4%
Keratitis
3%
Activated partial thromboplastin time prolonged
3%
Breast pain
3%
Dyspnoea exertional
3%
Tinnitus
3%
Blood parathyroid hormone decreased
3%
Pollakiuria
3%
Bronchitis
3%
Cholangitis infective
3%
Non-cardiac chest pain
2%
Hypoalbuminaemia
2%
Rash maculo-papular
2%
Sepsis
2%
Electrocardiogram QT prolonged
2%
Hypocalcaemia
2%
Blood 1,25-dihydroxycholecalciferol increased
2%
Bacteraemia
2%
Failure to thrive
2%
Decubitus ulcer
2%
Pharyngitis
2%
Trichomegaly
2%
Palpitations
2%
Tachycardia
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%
Seizure
1%
Micturition urgency
1%
Hyperkalaemia
1%
Oesophageal varices haemorrhage
1%
Skin infection
1%
Biliary tract infection
1%
Intestinal obstruction
1%
Jaundice
1%
Thrombosis
1%
Septic shock
1%
Retinal detachment
1%
Enterobacter bacteraemia
1%
Complication associated with device
1%
Prostate cancer
1%
Kidney infection
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 2
~2010
Pemigatinib
2022
Completed Phase 2
~220
Retifanlimab
2018
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
367 Previous Clinical Trials
55,418 Total Patients Enrolled
Peter LangmuirStudy DirectorIncyte Corporation
2 Previous Clinical Trials
82 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research include elderly individuals?

"This trial is recruiting individuals aged 18 and up to 90 years old."

Answered by AI

Is my profile compatible with the requirements of this experiment?

"This clinical trial has capacity for 10 candidates with advanced malignancies between 18 and 90 years old. Eligibility is contingent on the patient's willingness to cooperate, avoid pregnancy or fathering children, and having no evidence of progressive disease following treatment with pemigatinib as monotherapy or combination therapy."

Answered by AI

How widespread is this clinical trial across various centers?

"This medical trial is taking place at Virginia Cancer Specialists, PC located in Fairfax, VA and MD Anderson Cancer Center situated in Charlotte, NC as well as Oncology Specialists of Charlotte based out of Santa Monica, CA with an additional 6 sites."

Answered by AI

Is enrollment still open for this research endeavor?

"Unfortunately, this medical trial is not currently accepting new candidates. Posted on July 12th 2021 and last updated June 27th 2022, the study remains on hold. Alternately, there are 2376 clinical trials for advanced malignancies enrolling patients and 997 studies involving Pemigatinib actively recruiting participants."

Answered by AI

For what maladies is Pemigatinib typically prescribed?

"Pemigatinib is a viable therapeutic option for patients suffering from malignant neoplasms, invasive melanoma, and microsatellite instability high."

Answered by AI

How have the safety profiles of Pemigatinib been appraised?

"Our team at Power has assigned a score of two to Pemigatinib, as clinical data exists in support of its safety but efficacy remains unproven."

Answered by AI

Are there any precedents to using Pemigatinib for research purposes?

"Pemigatinib was initially studied at City of Hope in 2010. Since then, the drug has been tested in 260 completed clinical trials and is now under investigation for 997 separate studies across a variety of locations including Fairfax, Virginia."

Answered by AI

How many individuals are currently participating in this clinical research?

"As of the latest update on June 27th 2022, this clinical trial is not accepting new participants. If you are seeking alternative studies, there are 2376 trials recruiting participants with advanced cancer and 997 for Pemigatinib specifically in progress."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.
2021. "The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04949191.
~3 spots leftby May 2025
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