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Tyrosine Kinase Inhibitor

Pemigatinib for Myeloproliferative Disorders

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

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

Awards & highlights

Study Summary

This trial will test if a new drug, pemigatinib, is effective and safe in treating subjects with a specific type of cancer that has rearranged FGFR1.

Who is the study for?

This trial is for people with a specific blood disorder involving FGFR1 rearrangement. Participants must have relapsed or be unsuitable for stem cell transplantation, have an ECOG performance status of 0-2, and expect to live at least 12 weeks. They can't join if they've taken selective FGFR inhibitors before or have certain mineralization conditions or eye disorders.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of Pemigatinib in treating myeloid/lymphoid neoplasms with FGFR1 rearrangement. It's designed to see how well this drug works on patients who've had previous treatments fail or aren't eligible for other therapies.See study design

What are the potential side effects?

Possible side effects of Pemigatinib may include issues related to abnormal mineral buildup in the body, changes affecting eyesight like corneal disorders, and interactions with drugs that affect liver enzymes responsible for breaking down substances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My cancer involves a specific genetic change (8p11 rearrangement) that activates FGFR1.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at protocol-defined timepoints through end of study, up to approximately 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at protocol-defined timepoints through end of study, up to approximately 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of participants who achieve Complete Response (CR) based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement

Secondary outcome measures

Duration of CR, defined as the time from first assessment of CR to the earlier of disease progression or death due to any cause

Duration of response, defined as the time from first assessment of CR or PR to the earlier of disease progression or death due to any cause

Overall survival

+5 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%

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

Dyspnoea

Vitamin D deficiency

Onycholysis

Cough

Hyperbilirubinaemia

Abdominal distension

Hypokalaemia

Hypertension

Paronychia

Onychoclasis

Blood creatinine increased

Aspartate aminotransferase increased

Growth of eyelashes

Fall

Punctate keratitis

Erythema

Nasal congestion

Platelet count decreased

Conjunctivitis

Lacrimation increased

Nail disorder

Nasopharyngitis

Neuropathy peripheral

Skin exfoliation

Taste disorder

Upper respiratory tract infection

Cataract

Eye pain

Chills

Blood bilirubin increased

Depression

Hyponatraemia

Ocular hyperaemia

Influenza like illness

Dysphagia

Vitreous floaters

Cystitis

Cholangitis

Flank pain

Hypotension

Acute kidney injury

Muscular weakness

Neck pain

Oral candidiasis

Hyperuricaemia

Weight increased

Pain

Ascites

Skin fissures

Lymphocyte count decreased

Keratitis

Breast pain

Activated partial thromboplastin time prolonged

Dyspnoea exertional

Tinnitus

Blood parathyroid hormone decreased

Pollakiuria

Bronchitis

Cholangitis infective

Non-cardiac chest pain

Hypoalbuminaemia

Rash maculo-papular

Blood 1,25-dihydroxycholecalciferol increased

Bacteraemia

Failure to thrive

Hypocalcaemia

Sepsis

Decubitus ulcer

Pharyngitis

Electrocardiogram QT prolonged

Trichomegaly

Palpitations

Tachycardia

Dysuria

Hyperglycaemia

Dysphonia

Device occlusion

Small intestinal obstruction

Blood 1,25-dihydroxycholecalciferol decreased

Chronic kidney disease

Biliary obstruction

Pleural effusion

Pneumonia

Hypercholesterolaemia

Micturition urgency

Biliary tract infection

Enterobacter bacteraemia

Hyperkalaemia

Jaundice

Oesophageal varices haemorrhage

Skin infection

Thrombosis

Kidney infection

Retinal detachment

Septic shock

Complication associated with device

Intestinal obstruction

Prostate cancer

Seizure

Pseudomonal bacteraemia

Varices oesophageal

Oral herpes

Clostridium difficile infection

Device leakage

Gynaecomastia

Somnolence

Catheter site infection

Gastrointestinal haemorrhage

Haematemesis

Hydronephrosis

Optic ischaemic neuropathy

Pneumonitis

Transaminases increased

C-reactive protein increased

Cancer pain

Candida infection

Confusional state

Herpes zoster

Musculoskeletal pain

Psoriasis

Blood chloride decreased

Cerebrovascular accident

Malignant biliary obstruction

Melaena

Paraplegia

Pneumonia aspiration

Pneumonia pneumococcal

Syncope

Haemorrhoids

Sinus pain

Urinary tract pain

100%

80%

60%

40%

20%

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: PemigatinibExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemigatinib

2022

Completed Phase 2

~220

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,118 Total Patients Enrolled

Philomena Collucci, MDStudy DirectorIncyte Corporation

Media Library

Myeloproliferative Neoplasms Clinical Trial 2023: Pemigatinib Highlights & Side Effects. Trial Name: NCT03011372 — Phase 2

Pemigatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03011372 — Phase 2

Frequently Asked Questions

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

What are the conditions that pemigatinib is most often used to treat?

"Pemigatinib is an effective treatment for human patients with unresectable, metastatic cholangiocarcinomas. This includes those with the fgfr2 protein mutation and advance directives in place."

Answered by AI

What other research has Pemigatinib been a part of in the past?

"There are 1,257 clinical trials registered on ClinicalTrials.gov for Pemigatinib with 13 of them being active as of now. Phase 3 trials represent the most advanced category of these investigations. Out of the 644 locations running Pemigatinib studies, some are in Petach Tikva and Manitoba."

Answered by AI

Are there any available openings for participants in this trial?

"This cancer clinical trial is no longer recruiting patients. The original post date was 4/25/2017, with the most recent edit on 6/24/2022. However, there are presently 2523 other cancer trials actively admitting participants and 13 trials for Pemigatinib that are still searching for patients."

Answered by AI

How many subjects are being tested in this clinical trial?

"Unfortunately, this clinical trial is no longer looking for patients that meet the requirements. The study was initially posted on April 25th, 2017 and updated for the last time on June 24th, 2022. However, there are presently 2523 trials actively enrolling cancer patients and 13 studies for Pemigatinib with open enrolment."

Answered by AI

Please tell us how many research hospitals are a part of this experiment?

"In total, 11 clinical trial sites are enrolling patients for this study. These include City of Hope National Medical Center in Duarte, California, Md Anderson Cancer Center in Houston, Texas, and Washington University School of Medicine in Saint Louis, Missouri as well as 8 other locations."

Answered by AI

Has Pemigatinib been deemed safe by the FDA for mass consumption?

"Pemigatinib's efficacy is yet to be proven, however, it has received a score of 2 due to the fact that there is some data supporting its safety."

Answered by AI

Has this type of trial been done before?

"Pemigatinib has been researched since 2017, when the first 47-person study was conducted by Incyte Corporation. After successful completion of the Phase 2 trial, there are now 13 active clinical trials involving Pemigatinib being carried out in 98 different cities spanning 41 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

2017. "A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03011372.

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