Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01991938
Status:
TERMINATED
Last Update Posted:
2017-01-27
First Post:
2013-11-18
Brief Title:
Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma
Sponsor:
Verastem Inc
Organization:
Verastem Inc
Study Overview
Official Title:
A Phase I Dose Escalation Study of VS-5584 a Dual PI3KmTOR Inhibitor in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitment and the companys decision to de-prioritize 5584 development
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 I open-label multicenter dose-escalation trial of VS-5584 a PI3KmTOR kinase inhibitor in subjects with advanced non-hematologic malignancies or lymphoma This clinical study is comprised of 2 sequential parts Part 1 Dose Escalation and Part 2 Expansion The purpose of this study is to evaluate the safety including the recommended Phase II dose pharmacokinetics the amount of VS-5584 in subjects blood and the anti-cancer activity of VS-5584 Biomarkers genes or proteins that may predict or show how subjects body may respond to VS-5584 will also be assessed in archival tumor tissue tumor biopsies in consenting subjects and blood samples
Detailed Description:
None
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