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Inhibitor

Pemigatinib for Bladder Cancer

Phase 2
Recruiting
Led By Noah M Hahn, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Prior histologically confirmed low- or intermediate-risk non-muscle invasive urothelial carcinoma of the bladder (NMIBC) defined according to specific characteristics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a drug called Pemigatinib to see if it can treat patients with a history of low- or intermediate-risk non-muscle invasive bladder cancer who have recurrent tumors. If the drug is effective, it will be given to patients 4-6 weeks before they undergo a standard treatment called transurethral resection of bladder tumor.

Who is the study for?
This trial is for adults over 18 with recurrent non-muscle invasive bladder cancer that was previously low- or intermediate-risk. They must be able to perform daily activities with little to no assistance (ECOG status 0-2) and have certain lab values within specific ranges. People can't join if they've had recent radiotherapy, surgery, or other cancer treatments, have high-grade urothelial carcinoma in their latest urine test, another active cancer besides some exceptions, or previous treatment with similar drugs.Check my eligibility
What is being tested?
The study tests Pemigatinib's effectiveness on patients with recurring bladder tumors who've had prior low- or intermediate-risk cancers. It's taken orally for 4-6 weeks before the standard tumor removal surgery (TURBT).See study design
What are the potential side effects?
While not explicitly listed here, side effects of Pemigatinib may include diarrhea, dry mouth, changes in hair color, nail problems and fatigue based on its action as a fibroblast growth factor receptor inhibitor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My bladder cancer is confirmed to be at a low or intermediate risk and has not invaded the muscle.
Select...
I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response rate of pemigatinib therapy
Secondary outcome measures
Characterize the safety profile of pemigatinib therapy
Maximal concentration (Cmax, nmol/L) of pemigatinib in urothelial tissue at post-treatment TURBT
Number of Participants with Complete Response and FGFR3 Mutational Status
+4 more

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%
Gastrooesophageal reflux disease
12%
Pruritus
12%
Nasal dryness
12%
Onychomadesis
11%
Rash
11%
Blood alkaline phosphatase increased
11%
Nail discolouration
11%
Alanine aminotransferase increased
10%
Pyrexia
10%
Abdominal pain upper
10%
Muscle spasms
10%
Nail dystrophy
10%
Oropharyngeal pain
10%
Trichiasis
9%
Dyspnoea
9%
Vitamin D deficiency
9%
Onycholysis
9%
Cough
8%
Hypertension
8%
Hyperbilirubinaemia
8%
Hypokalaemia
8%
Abdominal distension
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%
Weight increased
4%
Pain
4%
Ascites
4%
Skin fissures
4%
Lymphocyte count decreased
4%
Keratitis
3%
Breast pain
3%
Dyspnoea exertional
3%
Tinnitus
3%
Blood parathyroid hormone decreased
3%
Pollakiuria
3%
Bronchitis
3%
Activated partial thromboplastin time prolonged
3%
Cholangitis infective
3%
Non-cardiac chest pain
2%
Hypoalbuminaemia
2%
Rash maculo-papular
2%
Pharyngitis
2%
Hypocalcaemia
2%
Trichomegaly
2%
Sepsis
2%
Electrocardiogram QT prolonged
2%
Bacteraemia
2%
Failure to thrive
2%
Decubitus ulcer
2%
Blood 1,25-dihydroxycholecalciferol increased
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%
Prostate cancer
1%
Skin infection
1%
Retinal detachment
1%
Septic shock
1%
Biliary tract infection
1%
Enterobacter bacteraemia
1%
Jaundice
1%
Intestinal obstruction
1%
Micturition urgency
1%
Complication associated with device
1%
Kidney infection
1%
Oesophageal varices haemorrhage
1%
Thrombosis
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%
Hyperkalaemia
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
1%
Seizure
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

1Treatment groups
Experimental Treatment
Group I: Treatment: PemigatinibExperimental Treatment1 Intervention
Patients will receive pemigatinib for 4 to 6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemigatinib
FDA approved

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,837 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
362 Previous Clinical Trials
55,040 Total Patients Enrolled
Noah M Hahn, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Media Library

Pemigatinib (Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03914794 — Phase 2
Bladder Cancer Research Study Groups: Treatment: Pemigatinib
Bladder Cancer Clinical Trial 2023: Pemigatinib Highlights & Side Effects. Trial Name: NCT03914794 — Phase 2
Pemigatinib (Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03914794 — Phase 2

Frequently Asked Questions

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

What other exploratory investigations have been conducted on Pemigatinib?

"Presently, 13 medical trials are exploring the use of pemigatinib; one is in phase 3. In addition to Aachen, California, 644 other sites offer clinical trials incorporating this medication."

Answered by AI

How many participants are currently involved in this medical experiment?

"Affirmative. The details on clinicaltrials.gov clearly show that this research project, which was initially posted in October 2020 is currently recruiting individuals for the trial. 43 participants are needed from 1 site."

Answered by AI

Is this the inaugural instance of this kind of medical research?

"Since the inaugural study sponsored by Incyte Corporation in 2017, which included 47 participants, Pemigatinib has been under intense investigation. After receiving positive results from its Phase 2 trial approval, there are now 13 active studies occuring at 98 cities and 41 countries worldwide."

Answered by AI

Is it possible to still join this experiment?

"As per the details on clinicaltrials.gov, this research is actively recruiting patients since its initial posting date of October 2nd 2020 and most recently updated on October 31st 2022."

Answered by AI

What maladies has Pemigatinib been demonstrated to improve?

"Patients with unresectable, metastatic cholangiocarcinomas can implement pemigatinib as part of their advance directive to target the fgfr2 protein in humans."

Answered by AI

Has Pemigatinib been sanctioned by the FDA?

"Based on our analysis, Pemigatinib has been assigned a score of 2 which reflects the fact that there is limited data surrounding its efficacy and some clinical evidence for safety due to this being a phase 2 trial."

Answered by AI
~1 spots leftby May 2024