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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00127829
First received: August 5, 2005
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Tumors
Drug: Gefitinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 66
Study Start Date: July 2005
Study Completion Date: January 2008
Arms Assigned Interventions
Experimental: 1
Gefitinib (IRESSA®)
Drug: Gefitinib
Oral tablet
Other Name: IRESSA®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alison Armour, MD, IRESSA Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00127829     History of Changes
Other Study ID Numbers: D7913C00022
Study First Received: August 5, 2005
Last Updated: April 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Solid Tumors

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

ClinicalTrials.gov processed this record on April 15, 2014