Actively Recruiting
Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells
Led by UNICANCER · Updated on 2025-06-05
40
Participants Needed
6
Research Sites
170 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Alterations in the fibroblast growth factor receptor (FGFR) gene are involved in the development of cancer. These anomalies are found at very variable frequencies (from less than 1% to around 10%) in cancers of the bile ducts, bladder, uterus, brain, ovary, lung, airways, digestive tract, breast, etc. Pemigatinib is an anti-cancer drug that acts on cells with alterations in the FGFR gene. It is used in Europe to treat people with biliary tract cancer who carry a specific FGFR alteration. However, in various clinical trials, pemigatinib has shown interesting activity in a number of patients with different cancers presenting with an alteration in the FGFR gene. This treatment could therefore be effective in several types of cancer where an alteration in the FGFR gene is detected. The aim of this clinical trial is to learn if pemigatinib works to treat patients with recurrent and/or metastatic cancer (whatever the type of cancer excluding blood cancers and those already treated with pemigatinib) presenting an alteration in the FGFR gene. Patients will: * Take oral pemigatinig in 3-week cycles (every day for 2 weeks followed by one week without pemigatinib) as long as they benefit from it. * Visit the clinic once every 3 weeks for checkups and tests during the treatment period * Visit the clinic once every 3 months for checkups after stopping treatment for at least 12 months.
CONDITIONS
Official Title
Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed solid tumor
- Locally recurrent unresectable and/or advanced or metastatic disease with FGFR1, 2, or 3 fusion/rearrangement or mutation
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- No appropriate therapeutic alternative and FGFR inhibitor indicated by physician
- Estimated life expectancy greater than 3 months
- Measurable disease by RECIST 1.1 criteria
- Availability of 2 pre-treatment tumor evaluations 4 weeks to 3 months apart with no treatment in between
- Minimal tumor growth increase of 0.1 mm/day between pre-treatment and baseline scan
- Adequate blood cell counts (ANC > 1.5 x 10^9/L; platelets > 75 x 10^9/L; hemoglobin > 9.0 g/dL)
- Adequate liver function (ALT and AST < 2.5x ULN or < 5x ULN if liver metastasis; bilirubin < 1.5x ULN or < 2.5x ULN with Gilbert's syndrome or liver metastasis; ALP < 3x ULN)
- Adequate kidney function (creatinine clearance > 30 mL/min)
- Serum phosphate at or below upper limit of normal
- Potassium levels within normal range (supplementation allowed during screening)
- Men and women of childbearing potential agreeing to use contraception during trial and for one week after last dose
- Negative pregnancy test for women of childbearing potential within 14 days before treatment
- Affiliated with a social security system
- Signed informed consent form or consent confirmed by trusted person if unable
You will not qualify if you...
- Hematologic malignancies
- Known severe allergy to pemigatinib or its components
- Disease with FGFR alteration already covered by an approved FGFR inhibitor (e.g., cholangiocarcinoma with FGFR2 fusion)
- Prior treatment with selective FGFR inhibitors
- Participation in another clinical trial assessing FGFR inhibitors
- Significant corneal or retinal disorders
- Current other active malignancies except certain treated skin or cervical carcinomas
- History of disorders causing abnormal calcium/phosphate balance with ectopic soft tissue calcification
- Significant gastrointestinal disorders affecting drug absorption
- Inability to swallow or retain oral medication
- Uncontrolled or significant cardiac diseases including recent heart attack or severe heart failure
- Abnormal ECG considered clinically significant, including QTcF interval > 480 ms
- Active hepatitis B or C with elevated liver enzymes or cirrhosis
- Known HIV infection unless viral load undetectable
- Active infections requiring systemic treatment within 2 weeks before enrollment
- Recent anticancer therapies within 4 to 6 weeks depending on treatment type
- Use of potent or moderate CYP3A4 inhibitors or inducers shortly before treatment
- Conditions making participation undesirable or compliance unlikely
- Pregnant or breastfeeding women
- History of severe vitamin D deficiency requiring high-dose supplementation
- Participation in another therapeutic trial within 30 days prior
- Individuals under legal custody or guardianship
AI-Screening
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Trial Site Locations
Total: 6 locations
1
CHU de BREST
Brest, France
Actively Recruiting
2
Centre Antoine Lacassagne
Nice, France
Active, Not Recruiting
3
Institut Curie
Paris, France
Not Yet Recruiting
4
CHU Poitiers
Poitiers, France
Active, Not Recruiting
5
CHU Saint Etienne
Saint-Priest-en-Jarez, France
Active, Not Recruiting
6
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France, 54500
Active, Not Recruiting
Research Team
C
Céline MAHIER AIT OUKHATAR
CONTACT
M
Marta JIMENEZ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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