Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00651508

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm 25mg/m2

KOS-1584 25mg/m2

Group Type EXPERIMENTAL

KOS-1584

Intervention Type DRUG

25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.

Interventions

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KOS-1584

25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.

Intervention Type DRUG

Other Intervention Names

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BMS-878271

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV.
* Eligible patients must have received only one prior chemotherapy regime for Stage IIIB/IV NSCLC.
* Good performance status.

Exclusion Criteria

* Prior treatment with an epothilone.
* Known central nervous system (CNS) metastases.
* Any chemotherapy, radiation therapy or immunotherapy or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to first study drug administration.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Consultants In Blood Disorders & Cancer

Louisville, Kentucky, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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KOS-1584-203

Identifier Type: -

Identifier Source: secondary_id

CA202-002

Identifier Type: -

Identifier Source: org_study_id

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