Phase I Chinese PK

An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.

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Key information

Conditions

Advanced Solid, Malignant Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Guangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

histological and/or cytological confirmation of a malignant solid tumor
refractory to standard therapies or for which no appropriate therapies exist
WHO performance status 0-2

Exclusion criteria

patients with brain tumors or symptomatic cerebral metastases
systemic anticancer therapy within the last 4 weeks

Treatment and study plan

Vandetanib

Drug

100 mg every other day, 100mg once daily

Other names: ZD6474, ZACTIMA™

Vandetanib 300 mg

Drug

300mg once daily

Other names: ZD6474, ZACTIMA™

Primary outcomes

Area under the curve (AUC) (0-24) (ng.h/mL) after single dose

Time frame: Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Jul 19, 2007
Registry last updated: Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed