Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-27 @ 2:42 AM
Study NCT ID:
NCT02541903
Status:
TERMINATED
Last Update Posted:
2020-04-14
First Post:
2015-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor overall accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC. The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.
Detailed Description:
This is a non-randomized trial phase 2 trial in which the drug Gilotrif will be administered at an oral dosage of 40 mg daily. This will continue until there is disease progression or severe toxicities. Patients will undergo a clinical exam every 4 weeks as well as have blood collected. Radiographic scans will be done every 8 weeks.
Study Oversight
Has Oversight DMC:
True
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?: