Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124189
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2005-07-25
Brief Title:
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative DiseaseCLD
Sponsor:
Geron Corporation
Organization:
Geron Corporation
Study Overview
Official Title:
A Phase I Sequential Cohort Dose Escalation Trial to Determine the Safety Tolerability and Maximum Tolerated Dose of GRN163L in Patients With Chronic Lymphoproliferative Disease
Status:
COMPLETED
Status Verified Date:
2015-12
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:
The purpose of this study is to determine the safety and maximum tolerated dose of GRN163L in treating patients with refractory or relapsed chronic lymphoproliferative disease
Detailed Description:
Imetelstat Sodium GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells Inhibition of telomerase may result in antineoplastic effects High telomerase levels and short telomere lengths correlate with other markers of poor prognosis in patients with chronic lymphoproliferative disease
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