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| Sponsor: | Geron Corporation |
|---|---|
| Information provided by (Responsible Party): | 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 to patients with refractory or relapsed multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Imetelstat Sodium (GRN163L) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 20 |
| Study Start Date: | November 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
3+3 cohort dose escalation
|
Drug: Imetelstat Sodium (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| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Study Director: | Steve Kelsey, MD | Geron Corporation |
More Information
| Responsible Party: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT00594126 History of Changes |
| Other Study ID Numbers: | CP14A004 |
| Study First Received: | January 3, 2008 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Myeloma Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma Relapsed or Refractory Multiple Myeloma |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |