ZD6474 Phase IIa Dose Finding Multicentre Study

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

Official Title
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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]

Conditions
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Non Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: ZD6474 (vandetanib) 100mg
* Drug: ZD6474 (vandetanib) 200mg
* Drug: ZD6474 (vandetanib) 300mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZD6474 100mg<br>Daily dose | Drug: ZD6474 (vandetanib) 100mg<br>* once daily oral dose<br>* Other names: ZACTIMA™;|
| Experimental: ZD6474 200mg<br>daily dose | Drug: ZD6474 (vandetanib) 200mg<br>* once daily oral dose<br>* Other names: ZACTIMA;|
| Experimental: ZD6474 300mg<br>daily dose | Drug: ZD6474 (vandetanib) 300mg<br>* once daily oral dose<br>* Other names: ZACTIMA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Every 4 weeks till meeting discontinuation criteria | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Non Small Cell Lung Cancer