Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT01056757
Status:
TERMINATED
Last Update Posted:
2015-11-04
First Post:
2010-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Ribavirin for Patients With Metastatic Breast Cancer
Sponsor:
Jewish General Hospital
Organization:
Study Overview
Official Title:
A Phase I/II Exploratory Study of Ribavirin in Metastatic Breast Cancer Expressing Elevated eIF4E
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed because of new overlapping study with ribavirin.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn whether oral Ribavirin is safe and effective in treating patients with metastatic breast cancer, that have high levels of eIF4E.
Detailed Description:
Overexpression of eIF4E occurs in greater than 50% of BC, where it has been associated with clinical progression, angiogenesis and chemoresistance. eIF4E protein expression is not elevated in stroma or in benign tissue. A major focus in the future management of BC is to develop novel targeted therapeutics, with associated biomarkers of clinical value. It is possible that targeting a central regulator that can control multiple pathways might be more effective than targeting a single downstream molecule. In our preclinical studies, we have demonstrated that ribavirin inhibits proliferation of BC cell lines at clinically achievable concentrations by inhibiting its target, eIF4E. This trial addresses the important clinical issue of the lack of treatment for poor prognosis BC, characterized by overexpression of eIF4E. We will explore the use of eIF4E as therapeutic target and a predictive marker. We will determine whether targeting eIF4E with ribavirin, a commercially approved, inexpensive, oral therapeutic compound with a favourable toxicity profile, may present a novel treatment option for patients with aggressive, metastatic disease.
Study Oversight
Has Oversight DMC:
False
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?: