NCT00635973

Brief Summary

A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 cancer

Timeline
Completed

Started Feb 2000

Typical duration for phase_3 cancer

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

February 1, 2000

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

First QC Date

March 7, 2008

Last Update Submit

April 21, 2009

Conditions

Cancer

Keywords

IressaGefitinibCancerPatients diagnosed with cancer who have previously received Iressa in an Iressa clinical trial

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Every 28 days

Secondary Outcomes (2)

  • Progression Free Survival

    Every 28 days

  • Survival

    Every 28 days

Interventions

Gefitinib (Iressa)DRUG

Iressa

Eligibility Criteria

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

You may qualify if:

  • Received treatment in a previous Iressa clinical trial
  • Provided Informed Consent to participate in the trial
  • days or less since completing the previous Iressa trial.

You may not qualify if:

  • Radiotherapy completed more than 14 days before starting treatment in this trial
  • Incomplete healing from prior surgery
  • Withdrawal from previous Iressa trial due to unacceptable toxicity to major organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

February 1, 2000

Study Completion

October 1, 2003

Last Updated

April 22, 2009

Record last verified: 2009-04