Skip to main content
OpenTrials
Completed

NCT Number: NCT00496275

Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC

To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed non small cell lung cancer (stage IIIB-IV)
  • Life expectancy greater than 12 weeks
  • At least 1 measurable lesion greater than 10mm in smallest diameter.

Exclusion criteria

  • Prior treatment with anticancer agent
  • Brain metastases
  • Major surgery within last 4 weeks

Treatment and study plan

Zactima (ZD6474)

Drug

Vinorelbine plus cisplatin

Drug

Gemcitabine plus cisplatin

Drug

Primary outcomes

  1. Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Secondary outcomes

  1. Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered

    Time frame: Predetermined timepoints after dose administration

  2. Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Important dates

Study start
2006
Study completion
2007
First posted
Jul 4, 2007
Registry last updated
Aug 26, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.