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| Sponsor: | Exelixis |
|---|---|
| Information provided by: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT00704288 |
Purpose
The purpose of this study is to evaluate the objective response rate and 6-month progression-free survival rate of XL184 in subjects with recurrent or progressive glioblastoma multiforme. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme |
Drug: XL184 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of XL184 in Subjects With Progressive or Recurrent Glioblastoma Multiforme in First or Second Relapse |
| Estimated Enrollment: | 225 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: XL184
Gelatin capsules supplied in 25-mg and 100-mg strengths; continuous daily dosing
|
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, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Duke University, The Preston Robert Tisch Brain Tumor Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
More Information
| Responsible Party: | Paul Woodard, MD/Senior Director, Clinical Research, Exelixis, Inc. |
| ClinicalTrials.gov Identifier: | NCT00704288 History of Changes |
| Other Study ID Numbers: | XL184-201 |
| Study First Received: | June 20, 2008 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
GBM Malignant gliomas |
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |