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
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ClinicalTrials.gov Identifier: NCT01732549 |
Recruitment Status :
Terminated
(Development of tasquinimod in prostate cancer discontinued)
First Posted : November 26, 2012
Results First Posted : October 3, 2016
Last Update Posted : November 22, 2019
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Metastatic Castrate Resistant Prostate Cancer |
Interventions |
Drug: Tasquinimod Drug: Placebo |
Enrollment | 144 |
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 Details | A total of 219 patients were screened and 144 patients were randomised. |
Arm/Group Title | Tasquinimod | Placebo |
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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 |
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 |
Period Title: Overall Study | ||
Started | 71 | 73 |
Ongoing in Treatment Period:Data Cut-off | 12 | 12 |
Withdrawn During Treatment:Data Cut-off | 59 [1] | 61 [2] |
Ongoing Treatment Period:Final Analysis | 0 | 0 |
Withdrawn During Treatment:Final Analysi | 71 | 73 |
Completed | 0 | 0 |
Not Completed | 71 | 73 |
Reason Not Completed | ||
Adverse Event | 13 | 3 |
Consent withdrawn | 13 | 6 |
Disease progression | 37 | 50 |
Other | 8 | 14 |
[1]
Withdrawn during treatment period 59 (AE 13, Consent withdrawn 13, Disease progression 31, Other 2)
[2]
Withdrawn during treatment period 61 (AE 3, Consent withdrawn 6, Disease progression 46, Other 6)
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Arm/Group Title | Tasquinimod | Placebo | Total | |
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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 |
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 |
Total of all reporting groups | |
Overall Number of Baseline Participants | 71 | 73 | 144 | |
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ITT population: All randomised patients. Patients were allocated to the treatment they were randomised to. Patients randomised that have been actually dead before randomisation were not retained in the intention to treat (ITT) population
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 71 participants | 73 participants | 144 participants | |
69.6 (7.18) | 69.6 (5.57) | 69.6 (6.39) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 71 participants | 73 participants | 144 participants |
18 to ≤ 65 years | 18 | 17 | 35 | |
66 to ≤ 75 years | 40 | 45 | 85 | |
> 75 years | 13 | 11 | 24 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 71 participants | 73 participants | 144 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
71 100.0%
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73 100.0%
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144 100.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 71 participants | 73 participants | 144 participants |
Black/African American | 0 | 1 | 1 | |
Caucasian/White | 52 | 58 | 110 | |
Multiple Race | 1 | 0 | 1 | |
Missing | 18 | 14 | 32 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 71 participants | 73 participants | 144 participants |
Czech Republic | 5 | 1 | 6 | |
Belgium | 5 | 6 | 11 | |
Hungary | 2 | 2 | 4 | |
Denmark | 6 | 13 | 19 | |
Poland | 4 | 3 | 7 | |
Italy | 9 | 5 | 14 | |
United Kingdom | 8 | 6 | 14 | |
France | 17 | 14 | 31 | |
Lithuania | 7 | 10 | 17 | |
Germany | 3 | 3 | 6 | |
Spain | 5 | 10 | 15 | |
Weight
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 71 participants | 73 participants | 144 participants | |
83.7 (12.57) | 83.4 (15.09) | 83.6 (13.86) | ||
BMI
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 71 participants | 73 participants | 144 participants | |
27.67 (3.543) | 28.01 (4.399) | 27.84 (3.987) | ||
Ethnicity
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 71 participants | 73 participants | 144 participants |
Hispanic or Latino | 2 | 4 | 6 | |
Not Hispanic or Latino | 52 | 55 | 107 | |
Missing | 17 | 14 | 31 | |
ECOG Performance Status Score
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 71 participants | 73 participants | 144 participants |
0 (Normal Activity) | 39 | 31 | 70 | |
1 (Restricted Activity) | 32 | 38 | 70 | |
Missing | 0 | 4 | 4 | |
[1]
Measure Description: Eastern Co-operative Oncology Group (ECOG) Score: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity, but ambulatory & able to carry out work of a light or sedentary nature, e.g. light house work, office work, 2=Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours, 3=Capable of limited self-care,confined to bed or chair more than 50% of waking hours, 4=Completely disabled. Cannot carry on any self care. Totally confined to bed or chair, 5=Dead
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Region
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 71 participants | 73 participants | 144 participants |
Eastern Europe | 18 | 16 | 34 | |
Western Europe | 53 | 57 | 110 |
Name/Title: | Medical Director, Oncology |
Organization: | Ipsen |
Phone: | clinical.trials@ipsen.com |
EMail: | clinical.trials@ipsen.com |
Responsible Party: | Ipsen |
ClinicalTrials.gov Identifier: | NCT01732549 |
Other Study ID Numbers: |
8-55-58102-002 2012-001038-32 ( EudraCT Number ) |
First Submitted: | October 24, 2012 |
First Posted: | November 26, 2012 |
Results First Submitted: | April 29, 2016 |
Results First Posted: | October 3, 2016 |
Last Update Posted: | November 22, 2019 |