Trial intelligence / Profile preview

KOS-1584 in previously treated advanced NSCLC

NCT00651508Phase 2

Key facts

Status
Completed
Start
Apr 2008
Primary completion
Oct 2008
Countries
1
Modality
RNA-Targeting Small Molecules
Conditions
non-small cell lung cancer (NSCLC)
01

Overview

Phase 2, open-label, single-arm trial of KOS-1584 in non-small cell lung cancer (NSCLC), sponsored by Bristol Myers Squibb. Primary endpoint: Objective Response Rate at 1 year. Started Apr 2008; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Single Arm 25mg/m2

    KOS-1584 25mg/m2 IV

03

Who it enrols

Patients with Stage IIIB or IV NSCLC who have received only one prior chemotherapy regimen and have good performance status.

04

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Progression Free Survival

  • Time to Progression

  • Time to Treatment Failure

  • Duration of Response

  • Overall Survival

  • Safety

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