Trial intelligence / Profile preview

Plinabulin + Docetaxel in Advanced NSCLC

NCT00630110Phase 2

Key facts

Status
Completed
Start
Feb 2008
Primary completion
Jun 2011
Countries
6
Modality
Small Molecules
Conditions
non-small cell lung cancer (NSCLC)
01

Overview

Phase 2, randomised, open-label trial of plinabulin in non-small cell lung cancer (NSCLC) (2 arms), sponsored by Nereus Pharmaceuticals. Primary endpoint: Overall Survival. Started Feb 2008; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Docetaxel

    Docetaxel (75 mg/m2)

  • Plinabulin + Docetaxel

    Plinabulin (30 mg/m2) + Docetaxel (75 mg/m2)

03

Endpoints

Primary

  • Overall Survival

Secondary

  • Response Rate

  • Duration of Response

  • 6-month Survival Rate

  • Progression-Free Survival

  • Safety and Adverse Events

  • Pharmacokinetics

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