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

Prostate Cancer Clinical Trial

— ZENITH  

Official title:

A Randomized, Double-blind, Multicentre, Phase II Controlled Trial Assessing ZACTIMATM (Vandetanib) Against Placebo in Prolonging the Off-treatment Interval in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00686036
• Other study ID #: D4200L00010
• Status: Terminated
• Phase: Phase 2
• First received: May 27, 2008
• Last updated: April 27, 2011
• Start date: May 2008
• Est. completion date: October 2010

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of prostate cancer

• PSA greater than or equal to 5 ng/mL

• Recent completion of first hormone treatment (intermittent androgen deprivation with an LHRH analogue)

Exclusion Criteria:

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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• vandetanib
300 mg orally, once daily for up to 18 months
• Placebo

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Granby
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Canadian Urology Research Consortium

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess the Effect of Oral Vandetanib Compared to Placebo on the Proportion of Subjects Not Reaching a PSA = 5ng/mL by 52 Weeks During the Off-treatment Phase of ADT.		52 weeks	No
Secondary	To Assess the Effect of Oral Vandetanib Compared to Placebo on the Proportion of Subjects Not Reaching PSA = 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)		78 weeks during off-treatment phase of ADT	No
Secondary	To Determine the Effect Oral Vandetanib Compared to Placebo on Time to PSA Progression (PSA = 5ng/mL and PSA = 10ng/mL)		From the time o PSA rise from the date of randomization to both PSA = 5ng/mL and PSA = 10ng/mL	No
Secondary	To Investigate the Effect Oral Vandetanib Compared to Placebo on Serum Testosterone Levels		Change from baseline at each visit post-randomization until until week 78	No
Secondary	To Characterise the Safety Profile of Vandetanib at a Daily Dose of 300mg/Day Based on the Adverse Events, Laboratory Variables, ECG and Drug Tolerability		From the time of randomization to week 78	Yes

External Links

•   Cancer Study Locator (US and Canada only)