Tasquinimod for metastatic castrate-resistant prostate cancer
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate-Resistant Prostate Cancer
IRAS ID
66720
Contact name
Robert Huddart
Sponsor organisation
Active Biotech AB
Eudract number
2010-021870-12
Clinicaltrials.gov Identifier
Research summary
Prostate cancer is the most common male tumour in the Western world and a worldwide incidence of 25.3 per 100,000 makes it the second most common cancer in men. About a third of patients treated for localised prostate cancer experience recurrence. They usually undergo treatment to reduce male sex hormones. Although the majority of patients respond for several years, they all eventually progress. Some experience symptoms but an increasing number have no or mild symptoms. One treatment option at this stage is a secondary hormonal therapy such as ketoconazole. This can cause a 20-50% response, but responses are often short-lived and have not been shown to improve survival. Other strategies include watchful waiting or starting chemotherapy once symptoms occur. If a patient has progressed despite a reduction in male sex hormones, but not yet experienced symptoms, there is potential for a treatment to prevent or delay the onset of pain and disease progression. Tasquinimod has demonstrated activity in preventing the development of blood vessels that supply prostate cancer tumours and inhibiting tumour growth. It has been administered to 273 people and was generally well-tolerated. The purpose of this study is to confirm the effect of tasquinimod on delaying disease progression or death compared with placebo (dummy drug). Patients will be randomly assigned to receive tasquinimod or placebo in a 2:1 ratio. Initially, study visits will be performed every 2 weeks. Once patients reach a stable dose of study drug, they will attend visits every 3 months until they meet certain withdrawal criteria. During the study visits, procedures will include physical examination, vital signs, CT and bone scans, blood sampling and questionnaires. This study is sponsored by Active Biotech AB. Approximately 1200 patients will participate in this study in 40 countries worldwide with 25 patients from 4 hospitals in the UK.
REC name
HSC REC B
REC reference
11/NIR03/6
Date of REC Opinion
10 Mar 2011
REC opinion
Further Information Favourable Opinion