NCT04972253

Phase I BLASST-3 Trial

Biomarker-directed Neoadjuvant Therapy for Cisplatin-ineligible or Cisplatin-refusing Muscle-invasive Bladder Cancer: Phase I Bladder Cancer Signal Seeking Trial

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Guru P. Sonpavde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a single-center (DF/HCC) 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 U.S. Food and Drug Administration (FDA) has not approved infigratinib as a treatment for any disease.

Conditions

• Bladder Transitional Cell Carcinoma
• Bladder Cancer
• Fibroblast Growth Factor Receptor

Interventions

Type	Name	Description
DRUG	Infigratinib	Oral, dosage per protocol

Timeline

• Start date: 2021-12-23
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2021-07-22
• Last updated: 2022-08-10

Regulatory

• FDA-regulated drug study