Clinical Trial Results:
A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED 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
Summary
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EudraCT number |
2012-001038-32 |
Trial protocol |
ES BE CZ LT HU IT DK GB DE PL |
Global end of trial date |
20 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
13 May 2016
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First version publication date |
13 May 2016
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Other versions |
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Summary report(s) |
AE details |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
8-55-58102-002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ipsen Pharma
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Sponsor organisation address |
65 quai Georges Gorse, Boulogne-Billancourt, France, 92100
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Public contact |
Medical director, Department of Cancer Medicine, Ipsen Pharma, clinical.trials@ipsen.com
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Scientific contact |
Medical director, Department of Cancer Medicine, Ipsen Pharma, clinical.trials@ipsen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Dec 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Feb 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
20 May 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To compare the clinical efficacy (i.e. radiological progression free survival [PFS]) of tasquinimod maintenance therapy with placebo in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not progressed after a first line docetaxel based chemotherapy.
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Protection of trial subjects |
This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21 and with the ethical principles laid down in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 7
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Country: Number of subjects enrolled |
Spain: 15
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Country: Number of subjects enrolled |
United Kingdom: 14
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Country: Number of subjects enrolled |
Belgium: 11
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Country: Number of subjects enrolled |
Czech Republic: 6
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Country: Number of subjects enrolled |
Denmark: 19
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Country: Number of subjects enrolled |
France: 31
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Country: Number of subjects enrolled |
Germany: 6
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Country: Number of subjects enrolled |
Hungary: 4
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Country: Number of subjects enrolled |
Italy: 14
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Country: Number of subjects enrolled |
Lithuania: 17
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Worldwide total number of subjects |
144
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EEA total number of subjects |
144
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
28
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From 65 to 84 years |
115
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85 years and over |
1
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Recruitment
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Recruitment details |
The study was performed as a multicentre study at 51 investigational sites (of which 44 randomised patients) in Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Lithuania, Poland, Spain and United Kingdom (UK). | ||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 219 patients were screened and 144 patients were randomised. | ||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||
Blinding implementation details |
All of the study treatments were similar in size, colour, smell, taste and appearance allowing the blinded conditions of the study to be maintained.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Tasquinimod | ||||||||||||||||||||||||||||||||||||
Arm description |
1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression. Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2) | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
tasquinimod
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Investigational medicinal product code |
ABR-215050
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
0.25 to 1 mg
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||||||
Arm description |
1 capsule daily, taken orally with water and food until disease progression Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food. Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6) | ||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
0 mg
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Baseline characteristics reporting groups
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Reporting group title |
Tasquinimod
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Reporting group description |
1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression. Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
1 capsule daily, taken orally with water and food until disease progression Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food. Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tasquinimod
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Reporting group description |
1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression. Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2) | ||
Reporting group title |
Placebo
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Reporting group description |
1 capsule daily, taken orally with water and food until disease progression Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food. Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6) |
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End point title |
Time to Radiological Progression Free Survival [PFS] | ||||||||||||
End point description |
The time from the date of randomisation to the date of radiological progression or death due to any cause.
Intention to treat (ITT) Population
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End point type |
Primary
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End point timeframe |
Every 8 weeks until disease progression documentation (approximately up to 2.5 years)
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Statistical analysis title |
Stratified[a] | ||||||||||||
Statistical analysis description |
ITT Population
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Comparison groups |
Tasquinimod v Placebo
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Number of subjects included in analysis |
144
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0315 [1] | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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Notes [1] - Adjusted for visceral metastases, opioid analgesic use and region, demonstrating a reduction in the risk of progression of 40% for tasquinimod compared with placebo Method |
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Statistical analysis title |
Unstratified[b] | ||||||||||||
Statistical analysis description |
ITT Population
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Comparison groups |
Tasquinimod v Placebo
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Number of subjects included in analysis |
144
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0344 | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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End point title |
Overall Survival | ||||||||||||
End point description |
Overall survival is defined as the time from randomisation to death due to any cause.
ITT Population
Tasquinimod: The data for this outcome is not evaluable (NE), listed as 0. Median (90% Confidence Interval)= (NE to NE). Patients censored = 63, Patients at risk (t=0) = 71. Overall survival data are immature: only 8 deaths are reported
Placebo: The data for this outcome is not evaluable (NE), listed as 0. Median (90% Confidence Interval)= (NE to NE). Patients censored = 67, Patients at risk (t=0) = 73. Overall survival data are immature: only 6 deaths are reported
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End point type |
Secondary
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End point timeframe |
Every 3 months after study treatment stop until death (approximately up to 2.5 years)
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Statistical analysis title |
Stratified[a] | ||||||||||||
Statistical analysis description |
ITT Population
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Comparison groups |
Tasquinimod v Placebo
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Number of subjects included in analysis |
144
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.443 [2] | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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Notes [2] - Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value |
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End point title |
Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2) | ||||||||||||
End point description |
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.
ITT Population
Tasquinimod: Median (90% Confidence Interval)= (7.1 to 30.7). Patients censored = 28, Patients at risk (t=0) = 39.
Placebo: Median (90% Confidence Interval)= (12.6 to NA). Patients censored = 44, Patients at risk (t=0) = 47
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End point type |
Secondary
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End point timeframe |
Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)
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Statistical analysis title |
PFS 2 | ||||||||||||
Statistical analysis description |
ITT Population
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Comparison groups |
Tasquinimod v Placebo
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Number of subjects included in analysis |
144
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.5219 [3] | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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Notes [3] - Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value |
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End point title |
Symptomatic PFS | ||||||||||||
End point description |
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]
ITT Population
Tasquinimod: The data for this outcome is not evaluable (NE), listed as 0. Median (90% Confidence Interval)= (31.9 to NE). Patients censored = 48, Patients at risk (t=0) = 71
Placebo: The data for Median (90% Confidence Interval), is NE (Not evaluable). Patients censored = 54, Patients at risk (t=0) = 73
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End point type |
Secondary
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End point timeframe |
Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)
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Statistical analysis title |
Symptomatic PFS | ||||||||||||
Statistical analysis description |
ITT Population
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Comparison groups |
Tasquinimod v Placebo
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Number of subjects included in analysis |
144
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.5442 [4] | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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Notes [4] - Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value |
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End point title |
Time to Further Anticancer Treatment for Prostate Cancer | ||||||||||||
End point description |
Time from randomisation to further treatment for prostate cancer
ITT population
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End point type |
Secondary
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End point timeframe |
Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)
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Statistical analysis title |
Time to Further Anticancer Treatment for Prostate | ||||||||||||
Statistical analysis description |
ITT Population
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Comparison groups |
Tasquinimod v Placebo
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Number of subjects included in analysis |
144
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.112 [5] | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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Notes [5] - Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value |
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End point title |
Time to Deterioration in Functional Assessment of Cancer Therapy – Prostate (FACT-P) | ||||||||||||
End point description |
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)
ITT Population
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End point type |
Secondary
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End point timeframe |
Up to End of Study visit (approximately up to 2.5 years)
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Statistical analysis title |
Stratified[a] | ||||||||||||
Statistical analysis description |
ITT Population
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Comparison groups |
Tasquinimod v Placebo
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Number of subjects included in analysis |
144
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.2491 [6] | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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Notes [6] - Comments Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) & region (Eastern Europe, Western Europe). One-sided p-value |
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End point title |
Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score | ||||||||||||
End point description |
Baseline is defined as the 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 the 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 three levels: no problems, some problems, severe problems. The EQ-VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled "Best imaginable health state" and "Worst imaginable health state"
ITT population
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End point type |
Secondary
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End point timeframe |
Baseline and End-of-study Visit (approximately up to 2.5 years)
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No statistical analyses for this end point |
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End point title |
Safety Profile of Tasquinimod | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of subjects reporting adverse events
Safety Population: All patients who received at least one dose of study treatment. Patients were allocated to the treatment they actually received
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End point type |
Secondary
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End point timeframe |
At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Tasquinimod
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Reporting group description |
1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression. Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2) | |||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
1 capsule daily, taken orally with water and food until disease progression Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food. Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6) | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Details of SAE and common (incidence >5%) TEAEs has been attached as an appendix, since there are no occurence details available. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 May 2013 |
• Change in Inclusion Criteria concerning the cumulative rather than starting dose of docetaxel and consideration of PSA measurements, including addition of a fourth measurement in certain circumstances.
• Change in Exclusion Criterion by addition of history of venous thrombo embolic disease.
• Clarification of statistical analysis.
• A definition of visceral metastases has been added.
• Tumour assessment follow-up for radiological progression has been clarified.
• A list of disallowed foods were added due to their inhibitory effect on the activity of CYP 3A4.
• Clarification of laboratory abnormalities that had to be reported as AEs.
• Administrative changes, correction of typographical errors and alignment of sample collection times to be in accordance with the Schedule of Assessments.
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The study was terminated early due to the stop of the project as decided by sponsor. The trial included number of planned patients & number of events(PFS)were met to draw conclusions. Only follow-up of patients were discontinued earlier than planned. |