NCT00127829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

First QC Date

August 5, 2005

Last Update Submit

April 22, 2009

Conditions

Tumors

Keywords

Solid Tumors

Study Arms (1)

1

EXPERIMENTAL

Gefitinib (IRESSA®)

Drug: Gefitinib

Interventions

GefitinibDRUG

Oral tablet

Also known as: IRESSA®
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Los Angeles, California, United States

Location

Research Site

Palm Springs, California, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 9, 2005

Study Start

July 1, 2005

Study Completion

January 1, 2008

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations

US(2)