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

Genzyme

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: vandetanib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686036

D4200L00010

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

vandetanib

Experimental group

Description:

300 mg orally, once daily for up to 18 months

Treatment:

Drug: vandetanib

Placebo

Placebo Comparator group

Description:

orally, once daily for up to 18 months

Treatment:

Drug: Placebo