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ZD6474 Phase IIa Dose Finding Multicentre Study

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ClinicalTrials.gov Identifier: NCT00252746
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Carcinoma Drug: ZD6474 (vandetanib) 100mg Drug: ZD6474 (vandetanib) 200mg Drug: ZD6474 (vandetanib) 300mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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]
Study Start Date : December 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Publications:
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00252746     History of Changes
Other Study ID Numbers: D4200C00039
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
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