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Sponsored by: |
Exelixis |
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Information provided by: | Exelixis |
ClinicalTrials.gov Identifier: | NCT00704288 |
The purpose of this study is to evaluate the 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.
This study will enroll additional subjects in the near future upon a protocol amendment.
Condition | Intervention | Phase |
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Glioblastoma Multiforme |
Drug: XL184 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study of XL184 in Subjects With Progressive or Recurrent Glioblastoma Multiforme in First or Second Relapse |
Estimated Enrollment: | 46 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: XL184
Gelatin capsules supplied in 25-mg and 100-mg strengths; continuous daily dosing
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Francisco, California, United States, 94143 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02115 | |
United States, Texas | |
Houston, Texas, United States, 77030 |
Responsible Party: | Exelixis, Inc. ( Yifah Yaron, MD, PhD/Director, Clinical Research ) |
Study ID Numbers: | XL184-201 |
Study First Received: | June 20, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00704288 |
Health Authority: | United States: Food and Drug Administration |
GBM Malignant gliomas |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |