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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00080509 |
Purpose
The purpose of this study is to determine whether a potential drug known as KOS-862 or "Epothilone D" has an effect as a 2nd line treatment in non-small cell lung cancer (NSCLC) for patients having failed one prior platinum-containing chemotherapy regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: KOS-862 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 85 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | November 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | KOS-201/NO17352 |
| Study First Received: | April 5, 2004 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00080509 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
