Trial Information
A Phase IIA Study Evaluating the Efficacy of MK0457 as a 5-Day Continuous Infusion in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- Patients who are at least 18 years of age with cancer of the lung and who have had
either no previous treatment or 1 previous treatment for advanced cancer of the lung.
Certain other treatments may also be allowed (prior cytotoxic chemotherapy in the
adjuvant setting)
Exclusion Criteria:
- Patients who have had treatment with any investigational therapy within the past 30
days are not eligible.
- Patients who have had a disease or medical condition that is not controlled will not
be eligible.
- Patients who are pregnant or breastfeeding are not eligible.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy of MK0457 as a 5 day infusion as measured by radiological exams at baseline and after every other cycle of treatment. After 3 post-treatment radiological assessments, response will be measured after every third cycle.
Outcome Time Frame:
5 Days
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2006_008
NCT ID:
NCT00290550
Start Date:
October 2006
Completion Date:
November 2007
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Advanced Non-Small Cell Lung Cancer
- NSCLC
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms