ZD6474 Phase IIa Dose Finding Multicentre Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252746
First received: November 14, 2005
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively


Condition Intervention Phase
Non Small Cell Lung Carcinoma
Drug: ZD6474 (vandetanib)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel-group, Dose Finding Study to Assess the Efficacy and Safety of ZD6474 in Patients With Advanced, Metastatic, or Recurrent NSCLC Who Have Failed Previous Chemotherapy Regimens, at Least One of Which Contained Platinum [Title Abbreviated]

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively

Secondary Outcome Measures:
  • To assess the tolerability, safety, disease control rate, duration of response, time to progression, changes in quality of life and tumour-related and overall symptom improvements, and to characterise the PK and PK-PD relationship

Enrollment: 53
Study Start Date: December 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ZD6474 (vandetanib)
    once daily oral dose
    Other Name: ZACTIMA™
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent.
  • Life expectancy of 12 weeks or longer.

Exclusion Criteria:

  • Pregnancy, breast feeding or female patients wishing to become pregnant.
  • Treatment with a non-approved or investigational drug within 30 days before enrolment
  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 ClinicalTrials.gov identifier: NCT00252746

Locations
Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Osakasayama, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Okayama, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252746     History of Changes
Other Study ID Numbers: D4200C00039
Study First Received: November 14, 2005
Last Updated: April 7, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
NSCLC
Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014