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Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic (AGUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127829
First Posted: August 9, 2005
Last Update Posted: April 23, 2009
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.
Information provided by:
AstraZeneca
August 5, 2005
August 9, 2005
April 23, 2009
July 2005
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00127829 on ClinicalTrials.gov Archive Site
Not Provided
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Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
A Phase I, Open-Label, Dose Escalation Study Evaluating High-Dose Gefitinib (IRESSA®) on Weekly and Twice Weekly Schedules in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tumors
Drug: Gefitinib
Oral tablet
Other Name: IRESSA®
Experimental: 1
Gefitinib (IRESSA®)
Intervention: Drug: Gefitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
January 2008
Not Provided

Inclusion Criteria:

  • Histologically confirmed solid tumor refractory to conventional treatment or whom no standard of treatment exists
  • Life expectancy of > 12 weeks
  • World Health Organization (WHO) performance status of < 2

Exclusion Criteria:

  • Known severe hypersensitivity to gefitinib or any of the excipients of this product
  • Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks)
  • Incomplete healing from previous oncologic or other major surgery
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00127829
D7913C00022
Not Provided
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Not Provided
Alison Armour, MD, IRESSA Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
April 2009

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