Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase I Chinese PK

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 18, 2007
Last updated: March 11, 2010
Last verified: March 2009

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

Condition Intervention Phase
Advanced Solid, Malignant Tumors
Drug: Vandetanib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Estimated Enrollment: 36
Study Start Date: September 2006
Study Completion Date: November 2007
Intervention Details:
    Drug: Vandetanib

    Dose escalation:

    100 mg every other day, 100mg once daily, 300mg once daily

    Other Names:
    • ZD6474
    • ZACTIMA™

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00503711

Research Site
Guangzhou, China
Sponsors and Collaborators
Principal Investigator: Guan Zhongzhen, MD SYS Cancer Center
Study Director: Peter Langmuir, MD AstraZeneca
  More Information

No publications provided Identifier: NCT00503711     History of Changes
Other Study ID Numbers: D4200L00004
Study First Received: July 18, 2007
Last Updated: March 11, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
ZD6474 PK processed this record on March 03, 2015