Iressa v BSC (Best Supportive Care) in First Line NSCLC

NCT00259064 | Completed Phase 2

• 2 other identifiers: 1839IL/0711D7913C00711
• Study Type: interventional
• Target: 216
• Locations: 5 countries
• Sites: 36

Brief Summary

The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• To compare Iressa v best supportive care in terms of progression free survival

  Progression-free survival

Secondary Outcomes (4)

• To compare Iressa v best supportive care in terms of objective tumour response rate

  Overall objective tumour response rate (CR and PR) according to the RECIST criteria

• To compare Iressa v best supportive care in terms of overall survival

  Time to death

• To compare Iressa v best supportive care in terms of quality of life

  Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score

• To compare Iressa v best supportive care in terms of tolerability

  Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs

Other Outcomes (3)

• To investigate the correlation of the expression of biomarkers in tumour tissue obtained prior to gefitinib therapy with gefitinib clinical efficacy and to determine a set of biomarkers to enable patient selection for therapy.

  Efficacy (objective response rate and progression free survival), toxicity, EGFR signalling pathways markers, RNA expression profile, gene polymorphisms of pre specified germline and tumour genes, DNA methylation, plasma and urine proteomics

• To compare gefitinib + BSC versus Placebo + BSC in terms of Health Resource Utilisation

  The use of selected items of resource and concomitant medications including: number of in patient days, number of out patient visits, number of invasive procedures, pallative radiotherapy, concomitant medications.

• To compare gefitinib + BSC versus Placebo + BSC in terms of changes in pain and fatigue

  Changes in pain and fatigue as measured by the single items from the FACT-L physical well being domain.

Study Arms (2)

Gefitinib

EXPERIMENTAL

ZD1839 + BSC (best supportive care)

Drug: Gefitinib

Placebo

PLACEBO COMPARATOR

Placebo + BSC (best supportive care)

Other: Placebo

Interventions

Gefitinib DRUG

Gefitinib

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed NSCLC
• NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
• Not suitable for chemotherapy
• WHO Performance status 2 or 3

You may not qualify if:

• Newly diagnosed CNS mets
• Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
• Other co-existing malignancies
• ALT/AST greater than 5 x upper limit of normal
• ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (36)

Research Site

Bedford Park, Australia

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Chermside, Australia

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Concord, Australia

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Melbourne, Australia

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Newcastle, Australia

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Prahran, Australia

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Randwick, Australia

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Surrey, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Sault Ste. Marie, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Nová Ves pod Pleší, Czechia

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's-Hertogenbosch, Netherlands

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Amsterdam, Netherlands

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Eindhoven, Netherlands

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The Hague, Netherlands

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Zutphen, Netherlands

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Abergavenny, United Kingdom

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Birmingham, United Kingdom

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Cardiff, United Kingdom

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Leeds, United Kingdom

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Wolverhampton, United Kingdom

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Related Links

• CSR-1839IL-0711.pdf

MeSH Terms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• AstraZeneca Iressa Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2005
• First Posted: November 29, 2005
• Study Start: September 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: April 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-05

Locations

CA (18); AU (7); CZ (1); NL (5); GB (5)