An Open Label, Phase I, Rising Multiple Dose, Single Centre Study to Determine the PK and Tolerability of ZD6474 at Different Dose Levels in Chinese Patients With Solid Malignancy Tumor
Sponsor study identifier
interventional
36
1 country
1
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2007
Actual (reported)Study Completion
November 2007
Actual (reported)An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2007
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 18, 2007
Actual (reported)July 19, 2007
Actual (reported)November 2007
Actual (reported)November 2007
Actual (reported)Area under the curve (AUC) (0-24) (ng.h/mL) after single dose
Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1
100 mg Vandetanib every other day dosing
100 mg Vandetanib once daily dosing
300 mg Vandetanib once daily dosing
100 mg every other day, 100mg once daily
Research Site
Guangzhou, China
Zhang L, Li S, Zhang Y, Zhan J, Zou BY, Smith R, Martin PD, Jiang Y, Liao H, Guan Z. Pharmacokinetics and tolerability of vandetanib in Chinese patients with solid, malignant tumors: an open-label, phase I, rising multiple-dose study. Clin Ther. 2011 Mar;33(3):315-27. doi: 10.1016/j.clinthera.2011.04.005.
Clinical Sciences & Operations
Sanofi
36 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2007
First Posted
July 19, 2007
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
Contact the study team to confirm eligibility.
Primary Completion
November 2007
Actual (reported)Study Completion
November 2007
Actual (reported)Last Updated
August 31, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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