What side effects are associated with this type of intervention?

Common treatments for cancer, including targeted therapies like FGFR inhibitors, often have a range of side effects. For instance, treatments such as afatinib, fruquintinib, and ramucirumab have been associated with gastrointestinal issues like diarrhea and nausea, hematologic toxicities such as neutropenia and anemia, and other effects like fatigue and hypertension. Specifically, FGFR inhibitors like Pemigatinib can cause hyperphosphatemia, dry mouth, and nail toxicity. It is crucial for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for cancer treatment, including FGFR inhibitors like Pemigatinib. Pemigatinib is specifically approved for the treatment of cholangiocarcinoma with FGFR2 fusions or rearrangements. Other similar targeted therapies include Erdafitinib, an FGFR inhibitor approved for metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations. These approvals are part of a broader trend towards precision medicine, where treatments are tailored based on specific genetic mutations within tumors.

What other types of research exist?

Promising novel alternatives to Pemigatinib for cancer patients include: 1) Atezolizumab plus Bevacizumab, which has shown efficacy in renal cell carcinoma and non-small cell lung cancer. 2) Pembrolizumab, an anti-PD-1 antibody, which has demonstrated effectiveness in various cancers including non-small cell lung cancer and head and neck cancer. 3) Enfortumab Vedotin, an antibody-drug conjugate, which has shown promise in urothelial carcinoma. 4) Ramucirumab, a VEGFR2 antagonist, which is being used in combination therapies for gastric and esophageal cancers.

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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

No Placebo-Only Group

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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

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 • 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%

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

Dyspnoea

Vitamin D deficiency

Onycholysis

Cough

Abdominal distension

Hyperbilirubinaemia

Hypertension

Hypokalaemia

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

Pain

Weight increased

Ascites

Skin fissures

Lymphocyte count decreased

Keratitis

Activated partial thromboplastin time prolonged

Breast pain

Dyspnoea exertional

Tinnitus

Blood parathyroid hormone decreased

Pollakiuria

Bronchitis

Cholangitis infective

Non-cardiac chest pain

Decubitus ulcer

Sepsis

Blood 1,25-dihydroxycholecalciferol increased

Electrocardiogram QT prolonged

Hypoalbuminaemia

Failure to thrive

Bacteraemia

Hypocalcaemia

Palpitations

Pharyngitis

Rash maculo-papular

Tachycardia

Trichomegaly

Dysuria

Hyperglycaemia

Dysphonia

Device occlusion

Small intestinal obstruction

Blood 1,25-dihydroxycholecalciferol decreased

Chronic kidney disease

Biliary obstruction

Pleural effusion

Pneumonia

Hypercholesterolaemia

Prostate cancer

Skin infection

Retinal detachment

Septic shock

Thrombosis

Biliary tract infection

Complication associated with device

Enterobacter bacteraemia

Intestinal obstruction

Hyperkalaemia

Jaundice

Kidney infection

Oesophageal varices haemorrhage

Micturition urgency

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2810

Pemigatinib

2022

Completed Phase 2

~250

Retifanlimab

2018

Completed Phase 2

~430

0 / 2Eligibility criteria met

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.