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Sponsored by: |
Geron Corporation |
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Information provided by: | Geron Corporation |
ClinicalTrials.gov Identifier: | NCT00718601 |
The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of GRN163L and Velcade with and without Decadron when administered to patients with refractory or relapsed multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: GRN163L |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma |
Estimated Enrollment: | 40 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
3+3 cohort dose escalation
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Drug: GRN163L
25% dose escalation infused over 2 hours weekly
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cheryl Schwab | 650-566-7137 | cschwab@geron.com |
Contact: Catherine Howard | 650-566-7221 | choward@geron.com |
United States, New Jersey | |
Hackensack University Medical Center | Not yet recruiting |
Hackensack, New Jersey, United States, 07601 | |
Principal Investigator: David Seigel, md | |
United States, New York | |
St. Vincent's Comprehensive Cancer Center | Recruiting |
New York, New York, United States, 10011 | |
Principal Investigator: Sundar Jagganath, MD | |
United States, Texas | |
University of Texas Health Science Center | Not yet recruiting |
San Antonio, Texas, United States, 78229 | |
Principal Investigator: Swaminathan Padmanabhan | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Principal Investigator: William Bensinger, MD |
Study Chair: | Laurence Elias, MD | Geron Corporation |
Responsible Party: | Geron Corporation ( Laurence Elias, MD ) |
Study ID Numbers: | GRN163L CP14A011 |
Study First Received: | July 16, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00718601 |
Health Authority: | United States: Food and Drug Administration |
Myeloma Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma Relapsed or Refractory Multiple Myeloma |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |