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

Phase 2CompletedNCT00055471

AstraZeneca22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Prostatic Neoplasms Metastases, Neoplasm

Interventions

ZD4054 10 mgDRUG

1 x 10 mg oral tablets once daily

ZD4054 15 mgDRUG

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

ZD4054 22.5 mgDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Cleveland, Ohio, United States

Research Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLTs)

DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.

Time frame: Baseline to Day 29.

Secondary Outcomes

Total Prostate Specific Antigen (PSA) Concentration

Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).

Time frame: Baseline to Day 15.

Change in Total Prostate Specific Antigen (PSA)

Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = \[(measure at Day 15 - measure at baseline)/measure at baseline\]\*100

Time frame: Baseline to Day 15.

Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)

Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = \[(measure at Day 15 - measure at baseline)/measure at baseline\]\*100

Time frame: Baseline to Day 15.

Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)

Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = \[(measure at Day 15 - measure at baseline)/measure at baseline\]\*100

Time frame: Baseline to Day 15.

Data from ClinicalTrials.gov

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