Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer (TasQ003)
|ClinicalTrials.gov Identifier: NCT02057666|
Recruitment Status : Terminated (Development of tasquinimod in prostate cancer discontinued)
First Posted : February 7, 2014
Last Update Posted : July 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Asian Chemo-naïve Patients With Metastatic Castrate-resistant Prostate Cancer||Drug: Tasquinimod Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||January 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Main study: 1 capsule (0.25, 0.50 or 1 mg) daily, taken orally once a day with water and food (preferably the main evening meal).
A patient will initially receive 0.25 mg/day dose which will then be titrated through 0.5 mg/day (from Day 15) to a maximum of 1mg/day (from Day 29). If tolerability issues arise at 0.5 or 1 mg/day, patients will have their dose reduced to 0.25 or 0.5 mg/day, respectively.
Placebo Comparator: Placebo
1 capsule daily, taken orally once a day with water and food (preferably the main evening meal).
Placebo capsules are identical to tasquinimod capsules in appearance and excipients but exclude the active compound (tasquinimod), to be taken orally once a day with water and food (preferably the main evening meal).
- Time to Radiological Progression-Free Survival [PFS] [ Time Frame: Every 3 months, up to 3 years ]PFS is defined as the time from the date of randomisation to the date of radiological progression (confirmed by the central imaging assessment) or death due to any cause.
- Overall Survival [ Time Frame: Every 3 months, up to 3 years ]Overall survival is defined as the time from randomisation to death due to any cause
- Time to Symptomatic PFS based on local assessment [ Time Frame: Every 3 months, up to 3 years ]Symptomatic PFS, defined as the time from the date of randomisation to the date of appearance of pain (using pain visual analogue scale [VAS]) at a site with documented disease and analgesic use, or skeletal-related events, or death due to prostate cancer, whichever occurs first.
- Time from randomisation to further treatment for prostate cancer. [ Time Frame: Every 3 months, up to 3 years ]
- Quality of Life (QoL) [ Time Frame: Every 3 months, up to 3 years ]Quality of Life (QoL) measured by the Functional Assessment of Cancer Therapy Prostate Module (FACT-P) questionnaire and by the EuroQol 5-Dimension QoL Instrument (EQ-5D).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057666
|Korea, Republic of|
|Cheongju, Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Medical Director Uro-Oncology||Ipsen|