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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00059722
First received: May 2, 2003
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: ZD6474
Drug: Placebo
Drug: ZD1839
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Primary Outcomes:
  • Part A
  • i. Time to progression
  • ii. Incidence, CTC grade and type of Aes, clinicallyl significant laboratory abnormalities or changes in vital signs, and ECG changes
  • Part B

Secondary Outcome Measures:
  • Secondary Outcomes:
  • Part A
  • i. Objective response
  • ii. Disease control at 8 weeks
  • iii. Time to death
  • iv. WHO performance status
  • v. QOL and LCS from the FACT-L questionnaire
  • Part B
  • i. Objective response in subjects following treatment with the alternate study treatment
  • ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
  • iii. WHO performance status in subjects following treatment with the alternate study treatment
  • iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment

Estimated Enrollment: 160
Study Start Date: May 2003
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059722

  Show 46 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Oncology Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00059722     History of Changes
Obsolete Identifiers: NCT00072423
Other Study ID Numbers: 6474IL/0003
Study First Received: May 2, 2003
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
NSCLC
locally advanced or metastatic
second-line

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014