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Phase I Chinese PK

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00503711
First received: July 18, 2007
Last updated: March 11, 2010
Last verified: March 2009
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
Drug Information available for: Vandetanib
U.S. FDA Resources

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™
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503711

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

No publications provided

ClinicalTrials.gov 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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013