Phase I Chinese PK

August 29, 2016 updated by: Genzyme, a Sanofi Company

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100 mg Vandetanib eod
100 mg Vandetanib every other day dosing
Drug: Vandetanib
100 mg every other day, 100mg once daily
Other Names:
  • ZD6474
  • ZACTIMA™
Experimental: 100 mg Vandetanib od
100 mg Vandetanib once daily dosing
Drug: Vandetanib
100 mg every other day, 100mg once daily
Other Names:
  • ZD6474
  • ZACTIMA™
Experimental: 300 mg Vandetanib od
300 mg Vandetanib once daily dosing
Drug: Vandetanib 300 mg
300mg once daily
Other Names:
  • ZD6474
  • ZACTIMA™

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 18, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4200L00004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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