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Completed

NCT Number: NCT00298688

A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer

The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of written informed consent
  • Histologically confirmed, relapsed or refractory SCLCr
  • Aged 18 or over and a life expectancy of more than 2 months

Exclusion criteria

  • Any evidence of clinically active interstitial lung disease
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.

Treatment and study plan

Gefitinib

Drug

Primary outcomes

  1. To determine the disease control rate in these patients

Secondary outcomes

  1. To determine the objective response rate at trail closure in these patients

  2. To determine the time to progression-or-death in these patients

  3. To determine overall survival in these patients

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer

Important dates

Study start
2004
Study completion
2007
First posted
Mar 3, 2006
Registry last updated
Jun 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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