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Polyglutamate Paclitaxel vs Gemcitabine or Vinorelbine in PS2 NSCLC
NCT00054197Phase 3
Key facts
- Status
- Terminated
- Start
- Jan 2003
- Primary completion
- Oct 2004
- Countries
- 1
- Sponsor
- CTI BioPharma Corp.
- Modality
- Polymer-based Nanoparticles, Small Molecules
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised, open-label trial of paclitaxel poliglumex in non-small cell lung cancer (NSCLC) (2 arms), sponsored by CTI BioPharma Corp. Primary endpoint: Overall Survival. Started Jan 2003; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Polyglutamate Paclitaxel
CT-2103 IV every 21 days
Gemcitabine or Vinorelbine
Gemcitabine or Vinorelbine IV
03
Who it enrols
Patients with stage IIIB/IV or recurrent NSCLC, ECOG PS 2, chemotherapy naive, with adequate organ function.
04
Endpoints
Primary
Overall Survival
Secondary
Safety and Toxicity
Disease Control Rate
Time to Progression
Objective Response Rate
Improvement in Lung Cancer Symptoms
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