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NCT00071188 Clinical Trial

ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00071188
Other study ID # D4200C00007
Secondary ID D4200C00007(run-
Status Completed
Phase Phase 2
First received October 14, 2003
Last updated August 24, 2016
Start date February 2004
Est. completion date October 2007

Study information
Verified date August 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

Other known NCT identifiers
  • NCT00093392

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• ZD6474

• Paclitaxel

• Carboplatin

Locations
Country Name City State
Finland Research Site Helsinki
Finland Research Site Turku
France Research Site Besancon
France Research Site Lille
France Research Site Strasbourg
Germany Research Site Essen
Germany Research Site Frankfurt
Germany Research Site Mainz
Germany Research Site Ulm
India Research Site Pune
Italy Research Site Milano
Italy Research Site Orbassano
South Africa Research Site Cape Town
South Africa Research Site Johannesburg
South Africa Research Site Panorama
South Africa Research Site Parkland
South Africa Research Site Pretoria
Spain Research Site Barcelona
Spain Research Site Madrid
Spain Research Site Malaga
Spain Research Site Pamplona
Thailand Research Site Chiang mai
United States Research Site Austin Texas
United States Research Site Boston Massachusetts
United States Research Site Chicago Illinois
United States Research Site Concord California
United States Research Site Houston Texas
United States Research Site Los Angeles California
United States Research Site Lubbock Texas
United States Research Site Nashville Tennessee
United States Research Site Norfolk Virginia
United States Research Site Providence Rhode Island
United States Research Site Seattle Washington
United States Research Site St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Finland,  France,  Germany,  India,  Italy,  South Africa,  Spain,  Thailand, 

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