ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: ZD4054 10 mg; Drug: Placebo; Drug: ZD4054 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090363

D4320C00006

Trial 6

ZD4054

Details and patient eligibility

About

This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

Enrollment: 447 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgically or medically castrated
• Bone metastasis
• Rising PSA

Exclusion criteria

• Opiate use
• Prior chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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447 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo oral tablet once daily, with best supportive care

Treatment:

Drug: Placebo

ZD4054 10 mg

Experimental group

Description:

ZD4054 10 mg oral tablet once daily, with best supportive care

Treatment:

Drug: ZD4054 10 mg

ZD4054 15 mg

Experimental group

Description:

ZD4054 15 mg oral tablet once daily, with best supportive care

Treatment:

Drug: ZD4054 15 mg