Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00059722
Recruitment Status : Completed
First Posted : May 5, 2003
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: ZD6474 Drug: Placebo Drug: ZD1839 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.
Study Start Date : May 2003
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib




Primary Outcome Measures :
  1. Primary Outcomes:
  2. Part A
  3. i. Time to progression
  4. ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes
  5. Part B

Secondary Outcome Measures :
  1. Secondary Outcomes:
  2. Part A
  3. i. Objective response
  4. ii. Disease control at 8 weeks
  5. iii. Time to death
  6. iv. WHO performance status
  7. v. QOL and LCS from the FACT-L questionnaire
  8. Part B
  9. i. Objective response in subjects following treatment with the alternate study treatment
  10. ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
  11. iii. WHO performance status in subjects following treatment with the alternate study treatment
  12. iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
  • Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC

Exclusion Criteria:

  • Subjects who have received second-line or subsequent chemotherapy
  • Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059722


Locations
Layout table for location information
United States, Arkansas
Research Site
Pine Bluff, Arkansas, United States
United States, California
Research Site
Los Angeles, California, United States
Research Site
Palm Springs, California, United States
Research Site
San Diego, California, United States
United States, Florida
Research Site
Boca Raton, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Orange Park, Florida, United States
United States, Idaho
Research Site
Coeur d'Alene, Idaho, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Missouri
Research Site
St. Loius, Missouri, United States
Research Site
St. Louis, Missouri, United States
United States, New York
Research Site
Brooklyn, New York, United States
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Greenville, North Carolina, United States
United States, North Dakota
Research Site
Bismarck, North Dakota, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Argentina
Research Site
Buenos Aires, Argentina
Research Site
Mendoza, Argentina
Belgium
Research Site
Brussels (Jette), Belgium
Research Site
Brussels (Woluwé-St-Lambert), Belgium
Research Site
Brussels, Belgium
Research Site
Edegem, Belgium
Research Site
Liege, Belgium
Research Site
Wilrijk, Belgium
Germany
Research Site
Essen, Nordrhein-Westfalen, Germany
Research Site
Mainz, Rheinland-Pfalz, Germany
Research Site
Ryhope, Sunderland, Germany
Research Site
Berlin, Germany
Research Site
Essen, Germany
Research Site
Hamburg, Germany
Research Site
Mainz, Germany
South Africa
Research Site
Bloemfontein, South Africa
Research Site
Cape Town, South Africa
Research Site
Durban, South Africa
Research Site
Johannesburg, South Africa
Research Site
Lyttelton Manor, South Africa
Research Site
Parktown, South Africa
Research Site
Port Elizabeth, South Africa
Research Site
Pretoria, South Africa
United Kingdom
Research Site
Northwood, Middlesex, United Kingdom
Research Site
Cardiff, South Glamorgan, United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
Layout table for additonal information
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00059722    
Obsolete Identifiers: NCT00072423
Other Study ID Numbers: 6474IL/0003
First Posted: May 5, 2003    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
NSCLC
locally advanced or metastatic
second-line
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action