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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Tumors
Both
Tumors
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
D7913C00022
NCT ID:
NCT00127829
Start Date:
July 2005
Completion Date:
January 2008
Related Keywords:
- Tumors
- Solid Tumors
Name | Location |
|---|---|
| Research Site | Anaheim, California |
