Status:
TERMINATED
Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00686036
Start Date
May 1 2008
End Date
October 1 2010
Last Update
December 21 2016
Active Locations (11)
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1
Research Site
Calgary, Alberta, Canada
2
Research Site
Edmonton, Alberta, Canada
3
Research Site
Victoria, British Columbia, Canada
4
Research Site
Hamilton, Ontario, Canada