NCT00080509

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_2 lung-cancer

Status
terminated

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

Study Start

First participant enrolled

December 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
Last Updated

February 3, 2010

Status Verified

November 1, 2009

First QC Date

April 5, 2004

Last Update Submit

February 2, 2010

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • NSCLC

Interventions

KOS-862DRUG

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Brain metastases
  • Changes in the rhythm of your heart that are considered significant as determined by an ECG tracing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Interventions

desoxyepothilone B

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 5, 2004

First Posted

April 7, 2004

Study Start

December 1, 2003

Study Completion

November 1, 2004

Last Updated

February 3, 2010

Record last verified: 2009-11