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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00496275
First received: July 3, 2007
Last updated: April 8, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496275

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Nick Thatcher, MD Christie Hospitals NHS trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00496275     History of Changes
Other Study ID Numbers: D4200C00054
Study First Received: July 3, 2007
Last Updated: April 8, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
NSCLC
ZACTIMA

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Vinorelbine
Cisplatin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013