Effectiveness of KOS-862 in the Treatment of Lung Cancer

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00080509
• Other study ID #: KOS-201/NO17352
• Status: Terminated
• Phase: Phase 2
• First received: April 5, 2004
• Last updated: February 2, 2010
• Start date: December 2003
• Est. completion date: November 2004

Study information

• Verified date: November 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• KOS-862

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NSCLC