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Effectiveness of KOS-862 in the Treatment of Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00080509
Recruitment Status : Terminated
First Posted : April 7, 2004
Last Update Posted : February 3, 2010
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Drug: KOS-862 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2003
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. NSCLC

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Layout table for additonal information Identifier: NCT00080509     History of Changes
Other Study ID Numbers: KOS-201/NO17352
First Posted: April 7, 2004    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: November 2009
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Desoxyepothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents