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| Sponsored by: |
Exelixis |
| Information provided by: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT00704288 |
Purpose
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.
| Condition | Intervention | Phase |
|
Glioblastoma Multiforme |
Drug: XL184 |
Phase II |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Gelatin |
| 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: | March 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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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| Contact: Cheryl Brinkman | 210-372-0685 | cheryl.brinkman@quintiles.com |
| United States, California | |||||
| Recruiting | |||||
| San Francisco, California, United States, 94143 | |||||
| United States, Massachusetts | |||||
| Recruiting | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| United States, Texas | |||||
| Recruiting | |||||
| Houston, Texas, United States, 77030 | |||||
| Exelixis |
More Information
| Responsible Party: | Exelixis, Inc. ( Yifah Yaron, MD, PhD/Director, Clinical Research ) |
| Study ID Numbers: | XL184-201 |
| First Received: | June 20, 2008 |
| Last Updated: | August 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00704288 |
| Health Authority: | United States: Food and Drug Administration |
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