A Phase I Study of ZD1839 and Palliative Thoracic Radioth... | NCT00255489

Studies
A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer

NCT00255489

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 25, 2011Estimated

Enrollment

Phase

Phase 1

Conditions

Non-small-cell Lung Cancer

Interventions

Gefitinib
palliative thoracic radiotherapy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Nov 17, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2011

Last Update Posted Date

Jan 25, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To characterize the safety profile of ZD 1839 in these patients

Secondary Outcomes

Measure	Description	Time Frame
To measure the quality of life compared to baseline
To measure the change in disease related symptoms compared to baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of written informed consent
Patients requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2
Histologically or cytologically conformed non-small cell lung cancer
Aged 18 or over

Exclusion Criteria:

Previous thoracic radiotherapy
Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event
Known hypersensitivity to any component of study medication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca Iressa Medical Sciences Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Edinburgh			United Kingdom
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077156	Gefitinib

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Gefitinib	Drug
palliative thoracic radiotherapy	Procedure