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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
Not Enrolling
Both
Tumors

Thank you

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 SiteAnaheim, California