Safety Study to Explore Combination of Gefitinib (ZD1839,... | NCT00239291

Studies
Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

NCT00239291

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Apr 23, 2009Estimated

Enrollment

42Actual

Phase

Phase 1Phase 2

Conditions

Non-Metastatic Prostate Cancer

Interventions

Gefitinib, radiotherapy

Countries

Finland

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

Apr 2009

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

Jan 2003

Primary Completion Date

Not provided

Completion Date

May 2006Actual

First Submitted Date

Oct 13, 2005

First Submission Date that Met QC Criteria

Oct 13, 2005

First Posted Date

Oct 17, 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

Apr 22, 2009

Last Update Posted Date

Apr 23, 2009Estimated

Description Module

Brief Summary

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate 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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Name	Type	Description	Arm Group Labels	Other Names
Gefitinib, radiotherapy	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A: Safety (incidence of DLTs)
Part B: Tolerability

Secondary Outcomes

Measure	Description	Time Frame
EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer
PSA below 20 ng/mL
Lymph node negative
Non-metastatic
Written informed consent

Exclusion Criteria:

Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)
Distant or nodal metastases
Prostatectomy
Concomitant LHRH analog treatment
Previous or concomitant anti-androgens
Active ILD

Accepts Healthy Volunteers

Sex

Male

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 Finland Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Helsinki			Finland

Intervention Browse Module

MeSH Terms

ID	Term
D000077156	Gefitinib
D011878	Radiotherapy

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