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OpenTrials
Completed

NCT Number: NCT00047840

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

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.

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Key information

Conditions

Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD6474

Drug

Placebo

Drug

docetaxel

Drug

Primary outcomes

  1. Outcome Progression free survival

Secondary outcomes

  1. Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;

  2. Objective response rate and duration of response

  3. QoL and lung cancer subscale (LCS) from the FACT-L questionnaire

  4. WHO performance status

  5. Time to death

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.

Important dates

Study start
2002
Study completion
2006
First posted
Oct 24, 2002
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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