What side effects are associated with this type of intervention?

Pemigatinib, an FGFR2 inhibitor, commonly causes hyperphosphatemia, alopecia, diarrhea, fatigue, and stomatitis. Serious side effects can include retinal detachment and elevated liver enzymes. The chemotherapy regimen of gemcitabine plus cisplatin is associated with side effects such as neutropenia, thrombocytopenia, anemia, nausea, vomiting, and fatigue. Both treatments can lead to significant toxicity, and patients should be closely monitored for adverse effects.

What prior FDA approvals exist?

Pemigatinib is an FGFR2 inhibitor that has been studied for the treatment of unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement. Prior to Pemigatinib, the FDA approved other treatments for cholangiocarcinoma, including chemotherapy regimens such as gemcitabine and cisplatin. These treatments, however, do not specifically target FGFR2. The approval of Pemigatinib represents a move towards more targeted therapies in cholangiocarcinoma, focusing on specific genetic alterations like FGFR2 rearrangements.

What other types of research exist?

Promising novel alternatives to Pemigatinib for cholangiocarcinoma patients include: 1) Durvalumab (an immune checkpoint inhibitor) in combination with gemcitabine and cisplatin, which has shown efficacy in advanced biliary tract cancer. 2) Dabrafenib plus Trametinib for patients with BRAFV600E mutations, as demonstrated in the ROAR and NCI-MATCH trials. These treatments represent emerging options that could be considered in 2024.

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Alkylating agents

Pemigatinib vs Chemotherapy for Bile Duct Cancer (FIGHT-302 Trial)

Phase 3

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

Documented FGFR2 rearrangement

Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual)

Must not have

Received prior anticancer systemic therapy for unresectable and/or metastatic disease

Known additional malignancy that is progressing or requires active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug called pemigatinib against the usual cancer treatment. It focuses on patients with advanced bile duct cancer who have a specific change in their genes. The goal is to see if pemigatinib is more effective and safer than the usual treatment. Pemigatinib is the first of its kind approved in the US, receiving approval recently.

Who is the study for?

Adults with previously untreated, inoperable or metastatic cholangiocarcinoma (bile duct cancer) and confirmed FGFR2 rearrangement can join. They must have a good performance status, meaning they're relatively active and able to care for themselves. Participants should be willing to prevent pregnancy.

What is being tested?

The trial is testing the effectiveness and safety of pemigatinib compared to standard chemotherapy (gemcitabine plus cisplatin). It's for first-line treatment, which means it's the first therapy given after diagnosis.

What are the potential side effects?

Pemigatinib may cause side effects like hair loss, nail changes, fatigue, taste changes, dry skin or mouth sores. Chemotherapy with gemcitabine and cisplatin can lead to nausea, vomiting, low blood cell counts increasing infection risk, kidney damage and hearing problems.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a specific genetic change known as FGFR2 rearrangement.

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My cholangiocarcinoma is in stage IV and has not been treated.

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My cancer can be measured or seen on a scan.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for cancer that couldn't be removed by surgery.

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I have another cancer that is getting worse or needs treatment.

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I have a history of calcium or phosphate balance issues leading to soft tissue calcification.

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I haven't taken strong medication that affects liver enzymes in the last 14 days.

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I am allergic to pemigatinib, gemcitabine, cisplatin, or their ingredients.

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My liver disease is moderately to severely advanced.

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I do not have severe stomach or bowel problems that could affect drug absorption.

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I do not have serious or unmanaged heart problems.

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I haven't needed antibiotics or antiviral drugs for an infection in the last 2 weeks.

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My side effects from previous treatments are mild.

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I am not on any cancer treatments other than what this study offers.

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I have brain metastases or a history of uncontrolled seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival

Secondary study objectives

Disease control rate

Duration of response

Therapeutic procedure

+2 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%

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PemigatinibExperimental Treatment1 Intervention

Group II: Gemcitabine + CisplatinActive Control2 Interventions

Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible to cross over and receive pemigatinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemigatinib

2022

Completed Phase 2

~250

0 / 16Eligibility 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

Cholangiocarcinoma treatments often target specific genetic mutations or use chemotherapy to inhibit cancer growth. Pemigatinib, an FGFR2 inhibitor, works by blocking the fibroblast growth factor receptor 2 pathway, which is often altered in cholangiocarcinoma, thereby inhibiting tumor growth and proliferation. This targeted approach is crucial for patients with FGFR2 rearrangements as it offers a more personalized and potentially effective treatment. On the other hand, traditional chemotherapy agents like gemcitabine and cisplatin work by damaging the DNA of rapidly dividing cells, leading to cell death. These treatments are essential for managing cholangiocarcinoma, especially in cases where specific genetic targets are not identified.

Role of adjuvant and neoadjuvant therapy for resectable biliary tract cancer.Biliary tract cancers: understudied and poorly understood.Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study.