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A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Signed informed consent

- 18 years or older

- Histologically or cytologically confirmed locally advanced or metastatic NSCLC

- No prior chemotherapy/biological therapy/radiation therapy

- One or more measurable lesions

- Life expectancy more than 12 weeks

Exclusion Criteria:

- Brain metastases or spinal cord compression

- Currently active skin disease

- History of significant hemoptysis

- Abnormal blood chemistry

- Cardiac abnormalities

- Recent significant cardiac event

- Coexisting malignancies

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Principal Investigator

AstraZeneca ZD6474 Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00007

NCT ID:

NCT00071188

Start Date:

February 2004

Completion Date:

October 2007

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small-Cell Lung Carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteArlington Heights, Illinois  
Research SiteBeverly, Massachusetts  
Research SiteBranson, Missouri  
Research SitePawtucket, Rhode Island  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington