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

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Placebo; Drug: vandetanib

• Registration Number: NCT00686036
• Lead Sponsor: Genzyme, a Sanofi Company

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 therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-29
• Primary Completion: 2010-04
• Study Completion: 2010-10
• Results First Submitted: 2011-04-27
• Results First Submitted QC: 2011-04-27
• Results First Posted: 2011-05-24
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 17

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	orally, once daily for up to 18 months
vandetanib	vandetanib	300 mg orally, once daily for up to 18 months

Primary Outcome Measures

Name	Time	Method
Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)	52 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants 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
Serum Testosterone Levels	Change from baseline at each visit post-randomization until until week 78
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

Trial Locations

Locations (1)

Research Site; 🇨🇦 Granby, Canada