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An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy


Inclusion Criteria:



- Removal of prostate for prostate cancer

- Raised level of prostate specific antigen (PSA) post-surgery

- Can have received some radiation therapy

Exclusion Criteria:

- Any after surgery male hormone blocking therapy.

- Low white blood cell count

- Abnormal liver function test

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate

Principal Investigator

AstraZeneca Canada Oncology Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Canada: Health Canada

Study ID:

1839IL/0093

NCT ID:

NCT00265070

Start Date:

January 2003

Completion Date:

August 2011

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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