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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Dyspnoea

Vitamin D deficiency

Onycholysis

Cough

Hyperbilirubinaemia

Hypertension

Abdominal distension

Hypokalaemia

Paronychia

Onychoclasis

Blood creatinine increased

Aspartate aminotransferase increased

Growth of eyelashes

Fall

Punctate keratitis

Erythema

Nasal congestion

Platelet count decreased

Lacrimation increased

Conjunctivitis

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

Activated partial thromboplastin time prolonged

Breast pain

Dyspnoea exertional

Tinnitus

Blood parathyroid hormone decreased

Pollakiuria

Bronchitis

Cholangitis infective

Non-cardiac chest pain

Hypoalbuminaemia

Rash maculo-papular

Sepsis

Electrocardiogram QT prolonged

Hypocalcaemia

Blood 1,25-dihydroxycholecalciferol increased

Bacteraemia

Failure to thrive

Decubitus ulcer

Pharyngitis

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

Seizure

Micturition urgency

Hyperkalaemia

Oesophageal varices haemorrhage

Skin infection

Biliary tract infection

Intestinal obstruction

Jaundice

Thrombosis

Septic shock

Enterobacter bacteraemia

Complication associated with device

Prostate cancer

Kidney infection

Retinal detachment

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

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

~220

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

365 Previous Clinical Trials

54,861 Total Patients Enrolled

4 Trials studying Cholangiocarcinoma

443 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

Frequently Asked Questions

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

Has Pemigatinib been okayed by the FDA for medicinal use?

"Pemigatinib Phase 3 trial data suggest that the medication is safe and effective. Our team at Power gave it a rating of 3."

Answered by AI

Are there any other notable instances of Pemigatinib being used in a medical context?

"Pemigatinib is being studied in 1019 different clinical trials, with 346 of those being in Phase 3. The largest number of these trials are based in Shanghai, but Pemigatinib is being studied in 52540 locations around the world."

Answered by AI

What is Pemigatinib most commonly used to treat?

"Pemigatinib is typically used to treat patients who have undergone anthracycline-based therapy. Additionally, this medication can help those struggling with neoplasm metastasis, advance directives, and urinary bladder issues."

Answered by AI

Are people with the disease still able to enroll in this experiment?

"The listed dates on clinicaltrials.gov show that this clinical trial is currently looking for patients; the trial was first posted on 6/3/2019 and was last edited on 11/7/2022."

Answered by AI