Spots Global Cancer Trial Database for Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer
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Trial Identification
Brief Title: Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer
Official Title: A Phase III, Randomised, Double-Blind, Placebo-Controlled Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer
Study ID: NCT02057666
Study Description
Brief Summary: The primary objective was to confirm the effect of tasquinimod in delaying disease progression or death as compared with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC). Secondary objectives included further evaluation of the safety profile of tasquinimod, comparison of clinical benefits (such as overall survival and symptoms) of tasquinimod with placebo, to evaluate the quality of life impact and to determine the pharmacokinetics of tasquinimod.
Detailed Description: The study involved a 4-week Screening Period, Baseline Visit (Day 1) where the patient was randomised, followed by a Double Blind Treatment Period. Patients initially received tasquinimod (or corresponding placebo) at a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively. The Double Blind Treatment Period continued until the death of the patient or any criterion for withdrawal from study treatment was reached. Any placebo treated patients with radiological disease progression confirmed by the central imaging assessment, who remained asymptomatic or mildly symptomatic were, at the Investigator's discretion, given the option to continue on active treatment (tasquinimod) during an Open-Label Treatment Period, following the same titration rule described above until progression under active treatment. All other patients stopped study treatment. An End-of-Study Treatment/Withdrawal Visit was to be performed within 14 days after the last dose of study treatment and patients were then to be followed up every 6 months until 80% of the patients had died or 2 years after the last patient was randomised, whichever occurred last. A PK ancillary study was to be performed in a subgroup of 12 Asian-Chinese patients before randomisation; however, due to the early termination of this study, only some samples were analysed and no PK analyses were performed.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Beijing Chao-Yang Hospital Capital Medical University, Beijing, Beijing, China
Peking University First Hospital, Beijing, Beijing, China
Peking University People's Hospital, Beijing, Beijing, China
Beijing Friendship Hospital Capital Medical University, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Beijing Hospital of Ministry of Health, Beijing, Beijing, China
Southwest Hospital (the First Affiliated Hospital of Third Military Medical University PLA), Chongqing, Chongqing, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Guangshou First People's Hospital, Guangzhou, Guangdong, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Ruijin Hospital Shanghai Jiaotong University of Medicine, Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
Huadong Hospital Fudan University, Shanghai, Shanghai, China
Huashan Hospital Fudan University, Shanghai, Shanghai, China
Shanghai Tenth People's Hospital, Shanghai, Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
West China Hospital Sichuan University, Chengdu, Sichuan, China
Sichuan Academy of Sichuan Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
General Hospital Chengdu Military Region of PLA, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital College of Medicine Zhujiang University, Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Chungbuk National University Hospital, Cheongju, Chungcheong Province, Korea, Republic of
Chonnam National University Hospital, Gwangju, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Medical Director Uro-Oncology
Affiliation: Ipsen
Role: STUDY_DIRECTOR
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