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Sponsored by: |
Geron Corporation |
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Information provided by: | Geron Corporation |
ClinicalTrials.gov Identifier: | NCT00732056 |
The purpose of this study is to determine the maximum tolerated dose (MTD) of GRN163L in combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic breast cancer (MBC)
Condition | Intervention | Phase |
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Breast Cancer |
Drug: GRN163L |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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:
Any history of:
Within the last 12 months:
Active at study entry:
Contact: David Rhodes | (650) 566-7205 | drhodes@geron.com |
United States, Illinois | |
Ingalls Memorial Hospital | Recruiting |
Harvey, Illinois, United States, 60426 | |
Contact: Patricia Gowland 708-915-6849 PGOWLAND@ingalls.org | |
Principal Investigator: Mark Kozloff, MD | |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Jennifer Shonkwiler 317-278-7792 jenshonk@iupui.edu | |
Principal Investigator: Kathy Miller, MD |
Principal Investigator: | Kathy Miller, MD | Indiana University Melvin and Bren Simon Cancer Center |
Responsible Party: | Geron Corporation ( Fabio Benedetti, MD ) |
Study ID Numbers: | GRN163L CP14A010 |
Study First Received: | August 7, 2008 |
Last Updated: | May 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00732056 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Metastatic Breast Cancer Recurrent Breast Cancer |
Skin Diseases Paclitaxel Breast Neoplasms Bevacizumab |
Angiogenesis Inhibitors Breast Diseases Recurrence |
Skin Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Bevacizumab Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Breast Diseases |