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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00080509 |
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 |
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | KOS-201/NO17352 |
Study First Received: | April 5, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00080509 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |