ZD6474 Phase IIa Dose Finding Multicentre Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252746
First received: November 14, 2005
Last updated: April 24, 2015
Last verified: April 2015
  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) 100mg
Drug: ZD6474 (vandetanib) 200mg
Drug: ZD6474 (vandetanib) 300mg
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 [ Time Frame: Every 4 weeks for the first 24 weeks of treatment and then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response ] [ Designated as safety issue: No ]

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 [ Time Frame: Every 4 weeks till meeting discontinuation criteria ] [ Designated as safety issue: Yes ]
    Tumour assessments to evaluate disease control rate, duration of response, time to progression will be performed every 4 weeks for the first 24 weeks of treatment, then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response. Quality of life questionnaire - FACT-L will be given to subjects at baseline and at 4-week intervals during the study treatment (up to Week 12). Lung cancer subscale (LCS) for disease-related symptoms collection will be completed weekly (up to Week 12). Safety and tolerability will be assessed on the ongoing basis by AZ collection, and at the site visits by vital sign, ECG and lab assessments. Blood sampling for pharmacokinetics will be performed on day 8, 15, 22, 29, 57 and 85. In the event of QTc prolongation, PK sampling will continue with the additional ECG monitoring performed until the QTc has fallen below 460 msec.


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)
Arms Assigned Interventions
Experimental: ZD6474 100mg
Daily dose
Drug: ZD6474 (vandetanib) 100mg
once daily oral dose
Other Name: ZACTIMA™
Experimental: ZD6474 200mg
daily dose
Drug: ZD6474 (vandetanib) 200mg
once daily oral dose
Other Name: ZACTIMA
Experimental: ZD6474 300mg
daily dose
Drug: ZD6474 (vandetanib) 300mg
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

Publications:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00252746     History of Changes
Other Study ID Numbers: D4200C00039
Study First Received: November 14, 2005
Last Updated: April 24, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
NSCLC
Non Small Cell Lung Cancer

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

ClinicalTrials.gov processed this record on July 27, 2015