NCT06653777

Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells

Phase II Trial Evaluating the Efficacy of Pemigatinib in Patients With Recurrent and/or Metastatic Solid Tumor Harboring a FGFR Alteration

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Anti-cancer treatments targeting abnormalities in the FGFR gene are currently marketed for biliary tract and bladder cancers, having demonstrated a certain degree of efficacy. In clinical trials, these drugs have shown promising signs of efficacy in other types of cancer with the same FGFR gene alterations. All the patients included in this clinical trial will receive pemigatinib. The expected benefit for patient is the control of the disease through stabilization, reduction or even disappearance of the cancer and related symptoms. The risks are mainly related to the adverse effects of the drug. The regular monitoring offered by the hospital and the additional examinations (such as more regular X-ray examinations, eye tests and blood tests) may constitute constraints. However, this monitoring and these examinations are carried out in order to better monitor and treat the effects of pemigatinib for both patient safety and the course of the disease.

Conditions

• Solid Tumor, Miscellaneous

Interventions

Type	Name	Description
DRUG	Pemigatinib	Pemigatinib will be administered orally once daily for 2 weeks followed by a 1-week off (intermittent schedule 2/1).

Timeline

• Start date: 2025-03-27
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2024-10-22
• Last updated: 2025-06-05

Locations

6 sites across 1 country: France