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Sponsored by: |
EntreMed |
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Information provided by: | EntreMed |
ClinicalTrials.gov Identifier: | NCT00306618 |
This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)
Condition | Intervention | Phase |
---|---|---|
Recurrent Glioblastoma Multiforme |
Drug: Panzem Nanocrystal Colloidal Dispersion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme |
Enrollment: | 27 |
Study Start Date: | January 2006 |
Study Completion Date: | December 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
The Brain Tumor Center, Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | David A. Reardon, M.D. | The Brain Center at Duke, Duke University Medical Center |
Responsible Party: | EntreMed, Inc. ( Chief Medical Officer ) |
Study ID Numbers: | ME-CLN-005 |
Study First Received: | March 22, 2006 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00306618 |
Health Authority: | United States: Food and Drug Administration |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma 2-methoxyestradiol |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Recurrence Neoplasms, Glandular and Epithelial |
Disease Attributes Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Mitosis Modulators Antimitotic Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Therapeutic Uses Tubulin Modulators Neoplasms, Neuroepithelial |