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Sponsors and Collaborators: |
Duke University AstraZeneca |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00613223 |
Primary Objective To determine maximum tolerated dose & dose limiting toxicity of vandetanib when combo w standard dosing of etoposide among pts w recurrent malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety & tolerability of vandetanib + etoposide in population To evaluate pharmacokinetics of vandetanib among malignant glioma pts on & not on EIAEDs when combo w etoposide Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among recurrent malignant glioma pts including radiographic response rate, 6-month progression free survival rate & median PFS
Condition | Intervention | Phase |
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Gliosarcoma Glioblastoma |
Drug: Vandetanib and Etoposide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Dose Escalation of Vandetanib (Zactima, ZD6474) in Combination With Etoposide for Malignant Gliomas |
Estimated Enrollment: | 48 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pts taking EIAEDs
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Drug: Vandetanib and Etoposide
Vandetanib will be given orally once day. Swallow tablet with 240 ml of non-carbonated water. Initial dose is 50 mg/day for stratum 1 & 200 mg/day for stratum 2. Etoposide will be taken by mouth in capsule form at dose of 50 mg/day for 1st 21 days of 28-day cycle. You will not take etoposide for following 7 days of the cycle. Everyone in study will receive dose of etoposide which is based on height & weight.
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2: Experimental
Pts not taking EIAEDs
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Drug: Vandetanib and Etoposide
Vandetanib will be given orally once day. Swallow tablet with 240 ml of non-carbonated water. Initial dose is 50 mg/day for stratum 1 & 200 mg/day for stratum 2. Etoposide will be taken by mouth in capsule form at dose of 50 mg/day for 1st 21 days of 28-day cycle. You will not take etoposide for following 7 days of the cycle. Everyone in study will receive dose of etoposide which is based on height & weight.
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This is open-label, single center, 2-arm phase I dose-escalation study of vandetanib administered orally on continuous daily dosing schedule + oral etoposide among adult pts w recurrent/relapsing MG. Pts will be stratified based on whether they are receiving EIAEDs & each stratum will independently dose escalate. Dose of vandetanib will be increased in successive cohorts of patients. Etoposide will be given daily at dose of 50mg/day for 21 days followed by 7 days with no etoposide. Cohorts of 3-6 subjects will accrue at each dose level until MTD is defined. Subjects will be adult pts w histologically confirmed malignant glioma who are presenting at time of recurrence/relapse. Up to 48 subjects will be enrolled.
Sample size will be based on modified, classical "3+3" dose escalation design. Primary safety & efficacy analysis will be conducted on all subject data at time all subjects who are still receiving study drug will have completed at least 4 cycles of treatment. Most common AEs associated w vandetanib are rash, diarrhea, & asymptomatic QTc prolongation. Protracted oral dosing of etoposide is associated w toxicity that is mild in most pts & consists mainly of myelosuppression & diarrhea. Less commonly, protracted etoposide dosing has been associated w more significant hematologic toxicity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pts have baseline evaluations ≤14days prior to 1st dose of study drug unless otherwise specified
Exclusion Criteria:
PT or PTT >1.5 x ULN of reference range
-Evidence of severe/uncontrolled systemic disease or any concurrent condition which in Investigator's opinion makes it undesirable for pt to participate in trial/which would jeopardize compliance w protocol
Contact: James J Vredenburgh, MD | (919) 681-3824 | james.vredenburgh@duke.edu |
Contact: Julie Norfleet | (919) 668-0673 | julie.norfleet@duke.edu |
United States, North Carolina | |
Duke University Health System | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: James J Vredenburgh, MD 919-681-3824 james.vredenburgh@duke.edu | |
Contact: Julie Norfleet (919) 668-0673 julie.norfleet@duke.edu | |
Principal Investigator: James J Vredenburgh, MD |
Principal Investigator: | James J Vredenburgh, MD | Duke University Health System |
Responsible Party: | Duke University Health System ( James J Vredenburgh ) |
Study ID Numbers: | 00001919 |
Study First Received: | January 29, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00613223 |
Health Authority: | United States: Food and Drug Administration |
Gliosarcoma Malignant Gliomas Etopophos Toposar VePesid Etoposide Vandetanib Zactima |
ZD6474 VP-16 Brain Tumor Recurring Malignant Brain Tumor Glioblastoma Glioma Malignant Glioma GBM |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Gliosarcoma Etoposide phosphate Etoposide Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Pharmacologic Actions |