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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00239291
Other study ID # 1839IL/0118
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 13, 2005
Last updated April 22, 2009
Start date January 2003
Est. completion date May 2006

Study information

Verified date April 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gefitinib, radiotherapy


Locations

Country Name City State
Finland Research site Helsinki

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: Safety (incidence of DLTs)
Primary Part B: Tolerability
Secondary EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis
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