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| Sponsored by: |
Geron Corporation |
| Information provided by: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT00594126 |
Purpose
The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered weekly to patients with refractory or relapsed multiple myeloma.
| Condition | Intervention | Phase |
|
Multiple Myeloma |
Drug: GRN163L |
Phase I |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Multiple Myeloma |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Weekly Administration of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma |
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1
3+3 cohort dose escalation
|
Drug: GRN163L
25% dose escalation infused over 2 hours weekly
|
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Liza Melchor | 650 473-8671 | fmelchor@geron.com |
| United States, Florida | |||||
| H. Lee Moffitt Cancer Center and Research Institute | Withdrawn | ||||
| Tampa, Florida, United States, 33612 | |||||
| United States, Maryland | |||||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | Recruiting | ||||
| Baltimore, Maryland, United States, 21231 | |||||
| Contact: Dionne Savage, RN 410-614-0382 dsavage3@jhmi.edu | |||||
| Principal Investigator: Carol A Huff, MD | |||||
| United States, Massachusetts | |||||
| Dana Farber Cancer Institute | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Contact: Nikhil Munshi, MD 617-632-4218 | |||||
| Principal Investigator: Nikhil Munshi, MD | |||||
| United States, New York | |||||
| Roswell Park Cancer Institute | Recruiting | ||||
| Buffalo, New York, United States, 14263 | |||||
| Contact: Dawn DePaolo, RN, BSN, CCRP 716 845-3824 dawnmarie.depaolo@RoswellPark.org | |||||
| Principal Investigator: Asher Chanan-Khan, MD | |||||
| Geron Corporation |
| Study Chair: | Laurence Elias, MD | Geron Corporation |
More Information
Related Info 
  |
| Responsible Party: | Geron Corporation ( Laurence Elias, MD ) |
| Study ID Numbers: | GRN163L CP14A004 |
| First Received: | January 3, 2008 |
| Last Updated: | August 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00594126 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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