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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00259064
First received: November 25, 2005
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
NSCLC
Drug: Gefitinib
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To compare Iressa v best supportive care in terms of progression free survival [ Time Frame: Progression-free survival ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare Iressa v best supportive care in terms of objective tumour response rate [ Time Frame: Overall objective tumour response rate (CR and PR) according to the RECIST criteria ] [ Designated as safety issue: No ]
  • To compare Iressa v best supportive care in terms of overall survival [ Time Frame: Time to death ] [ Designated as safety issue: No ]
  • To compare Iressa v best supportive care in terms of quality of life [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • To compare Iressa v best supportive care in terms of tolerability [ Time Frame: Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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. [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • To compare gefitinib + BSC versus Placebo + BSC in terms of Health Resource Utilisation [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • To compare gefitinib + BSC versus Placebo + BSC in terms of changes in pain and fatigue [ Time Frame: Changes in pain and fatigue as measured by the single items from the FACT-L physical well being domain. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2004
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib
ZD1839 + BSC (best supportive care)
Drug: Gefitinib
Placebo Comparator: Placebo
Placebo + BSC (best supportive care)
Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259064

  Show 36 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00259064     History of Changes
Other Study ID Numbers: 1839IL/0711, D7913C00711
Study First Received: November 25, 2005
Last Updated: August 13, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014