Phase I Chinese PK

Genzyme, a Sanofi Company36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid, Malignant Tumors

Interventions

VandetanibDRUG

100 mg every other day, 100mg once daily

Vandetanib 300 mgDRUG

300mg once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Guangzhou, China

Outcomes

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

Data from ClinicalTrials.gov

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