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Sponsors and Collaborators: |
Duke University Genentech OSI Pharmaceuticals |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00672243 |
Primary objective:
To determine the 6-month progression free survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.
Secondary objectives:
To further define the safety and tolerability of Erlotinib plus Sirolimus when administered to patients with recurrent GBM; and to evaluate progression free survival, radiographic response and overall survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.
Condition | Intervention | Phase |
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Glioblastoma Gliosarcoma |
Drug: Erlotinib, Sirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Erlotinib Plus Sirolimus for Patients With Recurrent Malignant Glioma Multiforme |
Estimated Enrollment: | 20 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Pts not receiving EIAEDs
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Drug: Erlotinib, Sirolimus
Estimated date of study completion is 6-9 mths from study initiation. Pts will take both Erlotinib & Sirolimus on daily dosing schedule. Each cycle will last 28 days. Erlotinib administered orally, continuously once daily in fasting state for each 28-day cycle. Dose of Erlotinib represents standardized dosing previously established in prior ph I studies among pts w RMG. Erlotinib when administered as single agent were well tolerated up to daily doses of 200 mg & 650 mg for pts not on & on EAEDs. In ph I study, daily doses of Erlotinib up to 250 mg for pts not on EIAEDs & 450 mg for pts on EIAEDs were evaluated in combo w standard temozolomide dosing. Based on ph I study, recommended ph II dosing schedule of Erlotinib combo therapy is 200 mg/day for pts not on EIAEDs/day & 450 mg/day for those on EIAEDs. In current study, dose of Erlotinib will be 150 mg/day for pts not on CYP3A4-EIAEDs & 500 mg/day for pts on EIAEDs.
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B: Experimental
Pts receiving EIAEDs
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Drug: Erlotinib, Sirolimus
Estimated date of study completion is 6-9 mths from study initiation. Pts will take both Erlotinib & Sirolimus on daily dosing schedule. Each cycle will last 28 days. Erlotinib administered orally, continuously once daily in fasting state for each 28-day cycle. Dose of Erlotinib represents standardized dosing previously established in prior ph I studies among pts w RMG. Erlotinib when administered as single agent were well tolerated up to daily doses of 200 mg & 650 mg for pts not on & on EAEDs. In ph I study, daily doses of Erlotinib up to 250 mg for pts not on EIAEDs & 450 mg for pts on EIAEDs were evaluated in combo w standard temozolomide dosing. Based on ph I study, recommended ph II dosing schedule of Erlotinib combo therapy is 200 mg/day for pts not on EIAEDs/day & 450 mg/day for those on EIAEDs. In current study, dose of Erlotinib will be 150 mg/day for pts not on CYP3A4-EIAEDs & 500 mg/day for pts on EIAEDs.
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The primary objective of this study will be to determine the 6-month progression free survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus. This is an exploratory, single-arm, phase II study designed to assess the anti-tumor activity of a combinatorial regimen consisting of Erlotinib plus Sirolimus among patients with recurrent GBM. The combinatorial regimen of Erlotinib plus Sirolimus is rationally designed to simultaneously inhibit upstream (EGFR) and downstream (mTOR) mediators of PI3/AKT signaling. In a recently completed phase I study, we determined that an EGFR inhibitor (Gefitinib) can be safely combined with Sirolimus at dose levels that are routinely used in the monotherapy setting. Therefore, the primary endpoint of this study is the probability of progression-free survival at 6 months among recurrent GBM patients treated with standard doses of Erlotinib plus Sirolimus. An important secondary objective is to further assess the safety of Erlotinib and Sirolimus for patients with recurrent GBM.
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 | |
Duke University Health System | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | David Reardon, MD | Duke University Health System |
Responsible Party: | Duke University Health System ( David A. Reardon, MD ) |
Study ID Numbers: | 00000345 |
Study First Received: | January 29, 2008 |
Last Updated: | February 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00672243 History of Changes |
Health Authority: | United States: Institutional Review Board |
GBM Brain tumor Erlotinib Sirolimus Glioblastoma multiforme |
Glioblastoma Gliosarcoma3 Tarceva Rapamune |
Erlotinib Sirolimus Glioblastoma Immunologic Factors Astrocytoma Clotrimazole Miconazole Tioconazole Protein Kinase Inhibitors Immunosuppressive Agents Temozolomide |
Recurrence Anti-Bacterial Agents Brain Neoplasms Neuroectodermal Tumors Antifungal Agents Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Neoplasms, Glandular and Epithelial |
Sirolimus Glioblastoma Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Antibiotics, Antineoplastic Protein Kinase Inhibitors Anti-Bacterial Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses |
Antifungal Agents Glioma Erlotinib Neoplasms by Histologic Type Astrocytoma Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial Gliosarcoma Neoplasms, Glandular and Epithelial |