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

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: July 3, 2007
Last updated: August 25, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Zactima (ZD6474)
Drug: Vinorelbine plus cisplatin
Drug: Gemcitabine plus cisplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Secondary Outcome Measures:
  • Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered [ Time Frame: Predetermined timepoints after dose administration ]
  • Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Enrollment: 17
Study Start Date: August 2006
Study Completion Date: May 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00496275

Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00496275     History of Changes
Other Study ID Numbers: D4200C00054
Study First Received: July 3, 2007
Last Updated: August 25, 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on May 25, 2017