Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653777
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Trial Evaluating the Efficacy of Pemigatinib in Patients With Recurrent andor Metastatic Solid Tumor Harboring a FGFR Alteration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AcSé PEMI
Brief 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 andor 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
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None