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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00427440 |
The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the treatment of Advanced Malignant Glioma.
Condition | Intervention | Phase |
---|---|---|
Advanced Malignant Glioma |
Drug: AMG 102 at 20 mg/kg Drug: AMG 102 at 10 mg/kg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Single Agent, Two-Stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Malignant Glioma |
Enrollment: | 61 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
AMG 102 at 10 mg/kg Dose Level: Experimental
Up to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.
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Drug: AMG 102 at 10 mg/kg
AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks
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AMG 102 at 20 mg/kg Dose Level: Experimental
Up to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.
|
Drug: AMG 102 at 20 mg/kg
AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except:
unwilling to use adequate contraceptive precautions during the course of the study and for 6 months after the last administration of investigational product, for:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050253 |
Study First Received: | January 25, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00427440 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Glioma Brain Tumor |
Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |