A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.
Inclusion Criteria:
- Confirmed non small cell lung cancer (stage IIIB-IV)
- Life expectancy greater than 12 weeks
- At least 1 measurable lesion greater than 10mm in smallest diameter.
Exclusion Criteria:
- Prior treatment with anticancer agent
- Brain metastases
- Major surgery within last 4 weeks
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin
Principal Investigator
Nick Thatcher, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Christie Hospitals NHS trust
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
D4200C00054
NCT ID:
NCT00496275
Start Date:
August 2006
Completion Date:
May 2007
Related Keywords:
- Non Small Cell Lung Cancer
- NSCLC
- ZACTIMA
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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