Trials / Completed
CompletedNCT00124189
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Geron Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GRN163L | Weekly intravenous infusion |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2005-07-27
- Last updated
- 2015-12-24
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00124189. Inclusion in this directory is not an endorsement.