A Phase 2 Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase 2 Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
To determine the antitumor activity, based on the confirmed objective response rate, of
KOS-862, administered intravenously weekly for 3 weeks every 4 weeks, in patients with
non-small cell lung cancer (NSCLC) whose disease has progressed following initial
chemotherapy for advanced or metastatic disease.
Inclusion Criteria:
- At least 18 years of age
- Measurable disease
- One previous treatment of a platinum based drug such as cisplatin or carboplatin
- At least 3 weeks since last surgery/radiation/chemotherapy
Exclusion Criteria:
- Brain metastases
- Changes in the rhythm of your heart that are considered significant as determined by
an ECG tracing
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
NSCLC
Authority:
United States: Food and Drug Administration
Study ID:
KOS-201/NO17352
NCT ID:
NCT00080509
Start Date:
December 2003
Completion Date:
November 2004
Related Keywords:
- Lung Cancer
- Lung Neoplasms
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