Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma

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: NCT00787410
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 6, 2008
First Posted Date  ICMJE November 7, 2008
Last Update Posted Date June 6, 2012
Study Start Date  ICMJE September 2003
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
  • To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure [ Time Frame: Proportion of patients responding at trial closure, ITT population ]
  • To further characterize the safety profile of ZD1839 at a 250mg daily dose [ Time Frame: Proportion of patients responding at trial closure, ITT population ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
  • To access the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure [ Time Frame: Proportion of patients responding at trial closure, ITT population ]
  • To further characterize the safety profile of ZD1839 at a 250mg daily dose [ Time Frame: Proportion of patients responding at trial closure, ITT population ]
Change History Complete list of historical versions of study NCT00787410 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
  • To estimate PFS (progression free survival) [ Time Frame: Proportion of patients alive and progression-free at trial closure, ITT population; Median time to progression or death; Proportion of patients alive and progression-free at 6 months ]
  • To estimate overall survival [ Time Frame: Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months ]
  • To estimate duration of response [ Time Frame: Median time from objective response to progression or death; only patients who responded are included in this analysis ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Official Title  ICMJE An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Brief Summary This study is a multicentre, open label, non-comparative, two stage phase II trial to assess the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will receive trial treatment as first-line therapy, administered continuously once daily until the completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or withdrawal of consent. Patients continuing to show evidence of response, disease stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond completion of the trail.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mesothelioma
Intervention  ICMJE Drug: ZD1839
250mg tablet, once daily, orally administered
Other Name: IRESSA
Study Arms  ICMJE Experimental: 1
Intervention: Drug: ZD1839
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2008)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically-confirmed malignant mesothelioma (based on pleural biopsy); eligibility for first line therapy for malignant mesothelioma
  • Uni or bi- dimensionally measurable disease
  • No prior radiotherapy within 3 weeks of enrolment into the trial
  • No significant comorbid disease

Exclusion Criteria:

  • Other malignancies, either co-existing or diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
  • Brian metastasis or leptomeningeal carcinomatosis
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or St. John's Wort
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00787410
Other Study ID Numbers  ICMJE 1839IL/0094
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Lee, MD Fraser Valley Cancer Centre Surrey Memorial Hospital, Surrey BC, Canada
PRS Account AstraZeneca
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP