NCT00503711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

July 18, 2007

Last Update Submit

August 29, 2016

Conditions

Advanced Solid, Malignant Tumors

Keywords

ZD6474 PK

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

100 mg Vandetanib eod

EXPERIMENTAL

100 mg Vandetanib every other day dosing

Drug: Vandetanib

100 mg Vandetanib od

EXPERIMENTAL

100 mg Vandetanib once daily dosing

Drug: Vandetanib

300 mg Vandetanib od

EXPERIMENTAL

300 mg Vandetanib once daily dosing

Drug: Vandetanib 300 mg

Interventions

VandetanibDRUG

100 mg every other day, 100mg once daily

Also known as: ZD6474, ZACTIMA™
100 mg Vandetanib eod100 mg Vandetanib od
Vandetanib 300 mgDRUG

300mg once daily

Also known as: ZD6474, ZACTIMA™
300 mg Vandetanib od

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Guangzhou, China

Location

Related Publications (1)

  • 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.

    PMID: 21600385BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

vandetanib

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 19, 2007

Study Start

September 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

CN(1)