This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line

• Registration Number: NCT00047840
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2002-10-18
• Study First Submitted QC: 2002-10-23
• Study First Posted: 2002-10-24
• Study Completion: 2006-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
• Failure of first-line platinum-based chemotherapy

Exclusion Criteria

• Mixed small cell or non-small-cell histology
• Bronchoalveolar carcinoma
• Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
• Prior treatment with docetaxel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Outcome Progression free survival

Secondary Outcome Measures

Name	Time	Method
Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
Objective response rate and duration of response
QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
WHO performance status
Time to death

Trial Locations

Locations (1)

Research Site; 🇭🇺 Torokbalint, Hungary