Trials / Completed
CompletedNCT00594126
Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma
A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- 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 the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Imetelstat Sodium (GRN163L) | 25% dose escalation infused over 2 hours weekly |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2008-01-15
- Last updated
- 2015-12-24
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00594126. Inclusion in this directory is not an endorsement.