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NCT00127829 Clinical Trial

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

Tumors Clinical Trial

— AGUS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00127829
Other study ID # D7913C00022
Secondary ID
Status Completed
Phase Phase 1
First received August 5, 2005
Last updated April 22, 2009
Start date July 2005
Est. completion date January 2008

Study information
Verified date April 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gefitinib
Oral tablet

Locations
Country Name City State
United States Research Site Los Angeles California
United States Research Site Palm Springs California

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

See also
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