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CompletedNCT00651508Updated May 17, 2016

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

A Phase 2 interventional study of KOS-1584 in Non-Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-17.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Patients with Advanced or Metastatic stage IIIB/IV Non-Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 1 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Single Arm 25mg/m2

    KOS-1584 25mg/m2

    Drug: KOS-1584

Interventions

  • DrugKOS-1584

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

    Also known as: BMS-878271

06

What researchers measure

Primary outcomes

  1. Objective response rate of KOS-1584

    Time frame: up to one year

Secondary outcomes

  1. Progression Free Survival (PFS), Time to Progression (TTP), Time to Treatment Failure (TTF), time to response, duration of response, overall survival and safety of KOS-1584.

    Time frame: up to 2 years

07

Study locations

1 site
  • Consultants In Blood Disorders & Cancer
    Louisville, Kentucky 40207, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00651508
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 2, 2008
Start date
Apr 2008
Primary completion
Oct 2008
Completion
Oct 2008
Last update
May 17, 2016

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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