Non Small Cell Lung Carcinoma
Conditions
Keywords
NSCLC, Non Small Cell Lung Cancer
Brief summary
To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively
Interventions
once daily oral dose
DRUGZD6474 (vandetanib) 200mg
once daily oral dose
once daily oral dose
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Japan
Outcome results
None listed