Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca; Genzyme, a Sanofi Company
• Collaborator: Canadian Urology Research Consortium
• Treatments: Androgens

Criteria

Inclusion Criteria:

• Diagnosis of prostate cancer

• Prostate specific antigen (PSA) greater than or equal to 5 ng/mL

• Recent completion of first hormone treatment [intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue]

• Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)

Exclusion Criteria:

• Bone or soft tissue metastases

• Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack