Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04972253
Status:
WITHDRAWN
Last Update Posted:
2022-08-10
First Post:
2021-07-15
Brief Title:
Phase I BLASST-3 Trial
Sponsor:
Guru P Sonpavde
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Biomarker-directed Neoadjuvant Therapy for Cisplatin-ineligible or Cisplatin-refusing Muscle-invasive Bladder Cancer Phase I Bladder Cancer Signal Seeking Trial
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLASST-3
Brief Summary:
The aim of this research is to see whether using a drug that blocks a protein called FGFR fibroblast growth factor receptor prior to surgery is safe and effective in patients with bladder cancer that have mutations in FGFR3 or FGFR2 and who cannot receive chemotherapy with cisplatin prior to surgery
The name of the study drug involved in this study is
- Infigratinib
The name of the study drug involved in this study is
- Infigratinib
Detailed Description:
This is a single-center DFHCC prospective feasibility study to assess biomarker-directed neoadjuvant therapy in patients with cT2-T4aN0 MIBC who are candidates for radical cystectomy RC and ineligible for or refuse cisplatin-based neoadjuvant chemotherapy NAC
This research study involves using a drug that inhibits FGFR in patients with bladder cancer that have mutations in FGFR prior to surgery
The name of the study drug involved in this study is
- Infigratinib
The research study procedures include pre-screening for eligibility and study treatment including evaluations and follow up visits This pre-screening is already done as clinical care Study participants will receive study treatment for 2 months prior to surgery and will be followed for at least 1 year after undergoing surgery
It is expected that about 12 people will take part in this research study
This research study is a Phase I clinical trial which tests the safety of an investigational drug infigratinib and also tries to define the appropriate dose of the investigational drug to use for further studies Investigational means that the drug is being studied
This research study is also a Feasibility Study which is the first time investigators are examining this drug in patients with bladder cancer that has not spread to other organs The US Food and Drug Administration FDA has not approved infigratinib as a treatment for any disease
This research study involves using a drug that inhibits FGFR in patients with bladder cancer that have mutations in FGFR prior to surgery
The name of the study drug involved in this study is
- Infigratinib
The research study procedures include pre-screening for eligibility and study treatment including evaluations and follow up visits This pre-screening is already done as clinical care Study participants will receive study treatment for 2 months prior to surgery and will be followed for at least 1 year after undergoing surgery
It is expected that about 12 people will take part in this research study
This research study is a Phase I clinical trial which tests the safety of an investigational drug infigratinib and also tries to define the appropriate dose of the investigational drug to use for further studies Investigational means that the drug is being studied
This research study is also a Feasibility Study which is the first time investigators are examining this drug in patients with bladder cancer that has not spread to other organs The US Food and Drug Administration FDA has not approved infigratinib as a treatment for any disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None