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
Phase 2
- Conditions
- on Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080220354
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Both
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Primary Outcomes: To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively Secondary Outcomes: 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
- Secondary Outcome Measures
Name Time Method