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
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: 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 July 24, 2014