Trial information
A Study of Pertuzumab in Patients With Prostate Cancer.
Status: Completed
Protocol number: BO17004
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of pertuzumab on tumor progression in chemotherapy-naïve patients with hormone-refractory prostate cancer
Brief summary: This study will evaluate the efficacy and safety of intravenous pertuzumab in patients with hormone-refractory prostate cancer who have had no previous chemotherapy. The anticipated time on study treatment is 2+ years and the target sample size is <100 individuals.
Target sample size is
92.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Pharmacodynamics study
Condition: Prostate Cancer
Intervention type: Drug
Intervention name: pertuzumab
Primary outcome: 1. Efficacy: Tumor progression (as measured by PSA level, scans and clinical examination).
Key secondary outcomes: 1. Safety: Adverse events, cardiac measurements
Inclusion criteria:
- asymptomatic or mildly symptomatic hormone-refractory prostate cancer;
- progressive disease.
Exclusion criteria:
- prior chemotherapy, radionucleotide therapy or immunotherapy for prostate cancer;
- history of other malignancies (except adequately treated basal or squamous cell skin cancer);
- central nervous system disease or brain metastases;
- major surgery or traumatic injury within 4 weeks of study.
Gender: Males
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
France
Germany
Italy
Spain
United Kingdom
