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

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

This study is currently recruiting participants.

Verified by AstraZeneca, August 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00127829

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 I

MedlinePlus related topics: Cancer

Drug Information available for: ZD1839

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by AstraZeneca:

Estimated Enrollment:	66
Study Start Date:	July 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Gefitinib (IRESSA®)	Drug: Gefitinib Oral tablet

Eligibility

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

Contacts

Contact: AstraZeneca Clincal Information Center

1-800-236-9933

Locations

United States, California
Research Site	Recruiting
Los Angeles, California, United States
Research Site	Recruiting
Palm Springs, California, United States

Sponsors and Collaborators

AstraZeneca

More Information

Responsible Party:	AstraZeneca ( Alison Armour, MD, IRESSA Medical Science Director )
Study ID Numbers:	D7913C00022
Study First Received:	August 5, 2005
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00127829
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Solid Tumors

Study placed in the following topic categories:

Gefitinib
Recurrence

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009