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Alkylating agents

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

Phase 3
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

FIGHT-302 Trial Summary

This trial will compare the effectiveness of pemigatinib versus gemcitabine plus cisplatin chemotherapy as first-line treatment for people with cholangiocarcinoma that cannot be removed by surgery or has spread to other parts of the body.

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.Check my eligibility
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.See study design
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.

FIGHT-302 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has a specific genetic change known as FGFR2 rearrangement.
Select...
My cholangiocarcinoma is in stage IV and has not been treated.
Select...
My cancer can be measured or seen on a scan.
Select...
I am fully active or can carry out light work.

FIGHT-302 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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
Progression-free survival
Secondary outcome measures
Disease control rate
Duration of response
Therapeutic procedure
+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
9%
Dyspnoea
9%
Vitamin D deficiency
9%
Onycholysis
9%
Cough
8%
Hypokalaemia
8%
Hyperbilirubinaemia
8%
Hypertension
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%
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%
Breast pain
3%
Activated partial thromboplastin time prolonged
3%
Dyspnoea exertional
3%
Tinnitus
3%
Blood parathyroid hormone decreased
3%
Pollakiuria
3%
Bronchitis
3%
Cholangitis infective
3%
Non-cardiac chest pain
2%
Rash maculo-papular
2%
Hypoalbuminaemia
2%
Sepsis
2%
Hypocalcaemia
2%
Blood 1,25-dihydroxycholecalciferol increased
2%
Bacteraemia
2%
Failure to thrive
2%
Pharyngitis
2%
Electrocardiogram QT prolonged
2%
Decubitus ulcer
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%
Hyperkalaemia
1%
Complication associated with device
1%
Prostate cancer
1%
Oesophageal varices haemorrhage
1%
Intestinal obstruction
1%
Jaundice
1%
Septic shock
1%
Thrombosis
1%
Micturition urgency
1%
Retinal detachment
1%
Enterobacter bacteraemia
1%
Kidney infection
1%
Biliary tract infection
1%
Seizure
1%
Skin 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

FIGHT-302 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

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.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
369 Previous Clinical Trials
55,050 Total Patients Enrolled
5 Trials studying Cholangiocarcinoma
468 Patients Enrolled for Cholangiocarcinoma
Peter Langmuir, MDStudy DirectorIncyte Corporation
10 Previous Clinical Trials
595 Total Patients Enrolled

Media Library

Cholangiocarcinoma Research Study Groups: Pemigatinib, Gemcitabine + Cisplatin
~174 spots leftby Oct 2027
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