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

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ClinicalTrials.gov Identifier: NCT00127829
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : April 23, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.

Condition or disease Intervention/treatment Phase
Tumors Drug: Gefitinib Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2005
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Gefitinib (IRESSA®)
Drug: Gefitinib
Oral tablet
Other Name: IRESSA®


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127829


Locations
United States, California
Research Site
Los Angeles, California, United States
Research Site
Palm Springs, California, United States
Sponsors and Collaborators
AstraZeneca
More Information

Responsible Party: Alison Armour, MD, IRESSA Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00127829     History of Changes
Other Study ID Numbers: D7913C00022
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Solid Tumors

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