Phase I Chinese PK

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503711

Enrollment

Registered

2007-07-19

Start date

2006-09-30

Completion date

2007-11-30

Last updated

2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid, Malignant Tumors

Keywords

ZD6474 PK

Brief summary

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

Interventions

DRUGVandetanib

100 mg every other day, 100mg once daily

DRUGVandetanib 300 mg

300mg once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026