NCT00651508

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 17, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

March 26, 2008

Last Update Submit

April 19, 2016

Conditions

Non-Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Objective response rate of KOS-1584

    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.

    up to 2 years

Study Arms (1)

Single Arm 25mg/m2

EXPERIMENTAL

KOS-1584 25mg/m2

Drug: KOS-1584

Interventions

KOS-1584DRUG

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
Single Arm 25mg/m2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consultants In Blood Disorders & Cancer

Louisville, Kentucky, 40207, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

KOS-1584

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

March 26, 2008

First Posted

April 2, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 17, 2016

Record last verified: 2016-04

Locations

US(1)