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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 5, 2005
Last Updated Date	April 22, 2009
Start Date ^ICMJE	July 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00127829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Tumors
Intervention ^ICMJE	Drug: Gefitinib Oral tablet Other Name: IRESSA®
Study Arm (s)	Experimental: 1 Gefitinib (IRESSA®) Intervention: Drug: Gefitinib
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	66
Completion Date	January 2008
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00127829
Other Study ID Numbers ^ICMJE	D7913C00022
Has Data Monitoring Committee	Not Provided
Responsible Party	Alison Armour, MD, IRESSA Medical Science Director, AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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