A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms; Metastases, Neoplasm

Treatments: Drug: ZD4054 10 mg; Drug: ZD4054 22.5 mg; Drug: ZD4054 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00055471

4054IL/0004

Details and patient eligibility

About

The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer

Enrollment: 22 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men 18 years & older
• Confirmed diagnosis of prostate cancer with bone metastases

Exclusion criteria

• No more than 2 prior chemotherapy regimens
• No radiation, chemotherapy or bisphosphonates in the past 4 weeks

Trial design

22 participants in 3 patient groups

ZD4054 10 mg

Experimental group

Description:

1 x 10 mg oral tablets once daily

Treatment:

Drug: ZD4054 10 mg

ZD4054 15 mg

Experimental group

Description:

1 x 10 mg + 2 x 2.5 mg oral tablets once daily

Treatment:

Drug: ZD4054 15 mg

ZD4054 22.5 mg

Experimental group

Description:

2 x 10 mg + 1 x 2.5 mg oral tablets once daily

Treatment:

Drug: ZD4054 22.5 mg