A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.
18 Years
N/A
Both
Carcinoma, Non-Small Cell Lung, Lung Cancer
Trial Information
A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.
Inclusion Criteria:
- Confirmed advanced or metastatic non-small cell lung cancer
- Failure of first-line chemotherapy
- 1 or more measurable lesion by RECIST
Exclusion Criteria:
- Previous chemotherapy or radiotherapy within 4 weeks
- Significant cardiac events, arrythmias or other cardiac conditions
- Unacceptable laboratory measurements
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:
To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam.
Outcome Time Frame:
assessed at each visit
Safety Issue:
No
Principal Investigator
Richard deBoer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Western Hospital Footscray, Victoria, Australia
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
D4200C00041
NCT ID:
NCT00506051
Start Date:
July 2005
Completion Date:
October 2011
Related Keywords:
- Carcinoma
- Non-Small Cell Lung
- Lung Cancer
- Non-small cell lung cancer
- lung cancer
- alimta
- vandetanib
- phase 1
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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