Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511485
Status:
COMPLETED
Last Update Posted:
2015-02-27
First Post:
2007-08-02
Brief Title:
Study of Vintafolide MK-8109 EC145 in Participants With Progressive Adenocarcinoma of the Lung MK-8109-008 EC-FV-03
Sponsor:
Endocyte
Organization:
Endocyte
Study Overview
Official Title:
Protocol EC-FV-03 A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with progressive adenocarcinoma of the lung
Detailed Description:
This is a Phase II clinical trial of vintafolide administered to participants with progressive adenocarcinoma of the lung
Vintafolide is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor FR Experimental evidence shows that this target receptor is expressed on a significant portion of non-small cell lung cancers Early clinical evidence in a small number of Phase I patients suggests that vintafolide is generally well-tolerated without many of the side-effects observed in more-standard therapeutic agents This evidence suggests that vintafolide may be useful as a chemotherapy against progressive adenocarcinomas of the lung The primary objective of this study is to collect data on clinical benefit produced by therapy with vintafolide
All participants will undergo imaging with the FR targeting investigational imaging agent etarfolatide EC20 FolateScan during the screening period to confirm eligibility for the treatment portion of the clinical trial Clinical evidence suggests that etarfolatide may be used to identify patients with cancers that express the target receptor
Information about the safety and tolerability of both vintafolide and etarfolatide will be assessed
Vintafolide is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor FR Experimental evidence shows that this target receptor is expressed on a significant portion of non-small cell lung cancers Early clinical evidence in a small number of Phase I patients suggests that vintafolide is generally well-tolerated without many of the side-effects observed in more-standard therapeutic agents This evidence suggests that vintafolide may be useful as a chemotherapy against progressive adenocarcinomas of the lung The primary objective of this study is to collect data on clinical benefit produced by therapy with vintafolide
All participants will undergo imaging with the FR targeting investigational imaging agent etarfolatide EC20 FolateScan during the screening period to confirm eligibility for the treatment portion of the clinical trial Clinical evidence suggests that etarfolatide may be used to identify patients with cancers that express the target receptor
Information about the safety and tolerability of both vintafolide and etarfolatide will be assessed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EC-FV-03 | OTHER | Endocyte | None |