Effectiveness of KOS-862 in the Treatment of Lung Cancer

NCT ID: NCT00080509

Last Updated: 2010-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2004-11-30

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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

KOS-862

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Other Identifiers

KOS-201/NO17352

Identifier Type: -

Identifier Source: org_study_id