A Proof of Concept Study of Maintenance Therapy With Tasquinimod in Patients With Metastatic Castrate-resistant Prostate Cancer Who Are Not Progressing After a First Line Docetaxel Based Chemotherapy

The time from the date of randomisation to the date of radiological progression or death due to any cause. Radiological progression was defined \- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions \- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions.

Time frame: Every 8 weeks until disease progression documentation (approximately up to 2.5 years)

Population: Intention to treat (ITT) Population

Baseline is defined as last measurement collected prior to the first dose of study drug. End of Study visit (within 14 days of last dose of study treatment) The EQ-5D, a 5-item scale useful in health resource utilisation and cost comparisons between treatment groups designed for self-completion by patients consists of two pages \[EQ-5 descriptive system and EQ Visual Analogue Scale(VAS)\]. The EQ-5 descriptive system comprises five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems. The EQ-VAS records the respondent's self-rated health on a vertical VAS. The respondents are asked to mark health status on the day of the interview on a 10cm vertical scale with end points of 0 to100. There are notes at the both ends of the scale that the bottom rate(0) corresponds to the worst health you can imagine, and the highest rate(100) corresponds to the best health you can imagine

Time frame: Baseline and End-of-study Visit (approximately up to 2.5 years)

Population: ITT population

Overall survival is defined as the time from randomisation to death due to any cause. The number of participants who died is presented since the Median was not reached for this assessment. Tasquinimod: Patients censored = 63, Patients at risk (t=0) = 71 Placebo: Patients censored = 67, Patients at risk (t=0) = 73

Time frame: Every 3 months after study treatment stop until death (approximately up to 2.5 years)

Population: ITT Population

Number of subjects reporting adverse events

Time frame: At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)

Population: Safety Population: All patients who received at least one dose of study treatment. Patients were allocated to the treatment they actually received

Symptomatic PFS is defined as the time from the date of randomisation to the date of symptomatic progression or death due to prostate cancer, whichever occurs first \[symptomatic progression as assessed by Brief Pain Inventory (BPI) and analgesic use\]. Symptomatic progression was defined by the occurrence of pain with documented disease, skeleton related adverse events. The median symptomatic PFS for placebo and tasquinimod groups was not reached. Tasquinimod: Patients censored = 48, Patients at risk (t=0) = 71 Placebo: Patients censored = 54, Patients at risk (t=0) = 73

Time frame: Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)

Population: ITT Population

End of Study visit (within 14 days of last dose of study treatment) Impact of tasquinimod on health related quality of life (QoL) - Analysis of time to deterioration in FACT-P The FACT-P measurement system is a validated collection of health related quality of life (HRQOL) questionnaires used to assess HRQOL in men with prostate cancer. It is appropriate for use with patients with any form of cancer and extensions of it have been used and validated in other chronic illness condition. The FACT-P is a self-administered 39-item scale comprising five domains: physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns. The individual subscale scores range from 0 to a high between 24 and 48 and the total score ranges between 0 and 156, with higher scores representing better Quality of Life (QoL)

Time frame: Up to End of Study visit (approximately up to 2.5 years)

Population: ITT population

Time from randomisation to further treatment for prostate cancer

Time frame: Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)

Population: ITT population

The time from the date of randomisation to the date of radiological progression free survival \[PFS\] on next-line therapy (PFS 2) or death due to any cause. Radiological progression was defined \- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions \- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions.

Time frame: Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)

Population: ITT Population