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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059722
• Other study ID #: 6474IL/0003
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2003
• Last updated: August 22, 2016
• Start date: May 2003
• Est. completion date: June 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 this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Other known NCT identifiers

• NCT00072423

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• ZD6474

• Placebo

• ZD1839

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Mendoza
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels (Jette)
Belgium	Research Site	Brussels (Woluwé-St-Lambert)
Belgium	Research Site	Edegem
Belgium	Research Site	Liege
Belgium	Research Site	Wilrijk
Germany	Research Site	Berlin
Germany	Research Site	Essen
Germany	Research Site	Essen	Nordrhein-Westfalen
Germany	Research Site	Hamburg
Germany	Research Site	Mainz
Germany	Research Site	Mainz	Rheinland-Pfalz
Germany	Research Site	Ryhope	Sunderland
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
United Kingdom	Research Site	Cardiff	South Glamorgan
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Northwood	Middlesex
United States	Research Site	Bismarck	North Dakota
United States	Research Site	Boca Raton	Florida
United States	Research Site	Brooklyn	New York
United States	Research Site	Chicago	Illinois
United States	Research Site	Coeur d'Alene	Idaho
United States	Research Site	Greenville	North Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Los Angeles	California
United States	Research Site	Madison	Wisconsin
United States	Research Site	New York	New York
United States	Research Site	Orange Park	Florida
United States	Research Site	Palm Springs	California
United States	Research Site	Pine Bluff	Arkansas
United States	Research Site	San Diego	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	St. Loius	Missouri
United States	Research Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Germany,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcomes:
Primary	Part A
Primary	i. Time to progression
Primary	ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes
Primary	Part B
Secondary	Secondary Outcomes:
Secondary	Part A
Secondary	i. Objective response
Secondary	ii. Disease control at 8 weeks
Secondary	iii. Time to death
Secondary	iv. WHO performance status
Secondary	v. QOL and LCS from the FACT-L questionnaire
Secondary	Part B
Secondary	i. Objective response in subjects following treatment with the alternate study treatment
Secondary	ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
Secondary	iii. WHO performance status in subjects following treatment with the alternate study treatment
Secondary	iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment