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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
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
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
Hide Arm/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

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Withdrawn During Treatment:Data Cut-off 59 [1] 61 [2]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Withdrawn During Treatment:Final Analysi 71 73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)
Arm/Group Title Tasquinimod Placebo Total
Hide Arm/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

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
Hide Baseline Analysis Population Description
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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 71 participants 73 participants 144 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
71
 100.0%
73
 100.0%
144
 100.0%
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
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
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
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
1.Primary Outcome
Title Time to Radiological Progression Free Survival [PFS]
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) Population
Arm/Group Title Tasquinimod Placebo
Hide Arm/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.
1 capsule daily, taken orally with water and food until disease progression
Overall Number of Participants Analyzed 71 73
Median (90% Confidence Interval)
Unit of Measure: weeks
31.7
(24.3 to 53.7)
22.7
(16.1 to 25.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tasquinimod, Placebo
Comments Stratified[a]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0315
Comments Log-rank test adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). Two-sided p-value.
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tasquinimod, Placebo
Comments Unstratified[b]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0344
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival Based on Number of Subjects Who Died
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tasquinimod Placebo
Hide Arm/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
1 capsule daily, taken orally with water and food until disease progression
Overall Number of Participants Analyzed 71 73
Measure Type: Number
Unit of Measure: participants
8 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tasquinimod, Placebo
Comments Stratified[a]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.4430
Comments [Not Specified]
Method Log Rank
Comments Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value
3.Secondary Outcome
Title Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)
Hide 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.

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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tasquinimod Placebo
Hide Arm/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
1 capsule daily, taken orally with water and food until disease progression
Overall Number of Participants Analyzed 71 73
Median (90% Confidence Interval)
Unit of Measure: weeks
19.3
(7.1 to 30.7)
24.1 [1] 
(12.6 to NA)
[1]

The data for this maximum confidence interval (CI) is not evaluable (NE), listed as Not Available (NA).

Patients censored = 44 Patients at risk (t=0) = 47

Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tasquinimod, Placebo
Comments Stratified[a]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5219
Comments [Not Specified]
Method Log Rank
Comments Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value
4.Secondary Outcome
Title Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death
Hide 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].

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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tasquinimod Placebo
Hide Arm/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.
1 capsule daily, taken orally with water and food until disease progression
Overall Number of Participants Analyzed 71 73
Measure Type: Number
Unit of Measure: participants
23 19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tasquinimod, Placebo
Comments Stratified[a]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.5442
Comments [Not Specified]
Method Log Rank
Comments Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value
5.Secondary Outcome
Title Time to Further Anticancer Treatment for Prostate Cancer
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Tasquinimod Placebo
Hide Arm/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.
1 capsule daily, taken orally with water and food until disease progression
Overall Number of Participants Analyzed 71 73
Median (90% Confidence Interval)
Unit of Measure: weeks
42.3
(32.0 to 58.0)
29.0
(23.1 to 39.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tasquinimod, Placebo
Comments Stratified[a]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.1120
Comments [Not Specified]
Method Log Rank
Comments Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value
6.Secondary Outcome
Title Time to Deterioration in Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Hide 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)

Time Frame Up to End of Study visit (approximately up to 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Tasquinimod Placebo
Hide Arm/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.
1 capsule daily, taken orally with water and food until disease progression
Overall Number of Participants Analyzed 71 73
Median (90% Confidence Interval)
Unit of Measure: weeks
8.1
(8.1 to 13.1)
15.7
(10.6 to 16.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tasquinimod, Placebo
Comments Stratified[a]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.2491
Comments [Not Specified]
Method Log Rank
Comments Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) & region (Eastern Europe, Western Europe). One-sided p-value
7.Secondary Outcome
Title Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Tasquinimod Placebo
Hide Arm/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.
1 capsule daily, taken orally with water and food until disease progression
Overall Number of Participants Analyzed 39 50
Median (Inter-Quartile Range)
Unit of Measure: Score on scale
-9.0
(-74 to 63)
-3.5
(-55 to 30)
8.Secondary Outcome
Title Safety Profile of Tasquinimod
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All patients who received at least one dose of study treatment. Patients were allocated to the treatment they actually received
Arm/Group Title Tasquinimod Placebo
Hide Arm/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.
1 capsule daily, taken orally with water and food until disease progression
Overall Number of Participants Analyzed 71 70
Measure Type: Number
Unit of Measure: participants
Any Treatment Emergent Adverse Event (TEAEs) 69 66
Intensity of TEAEs [Grade 3-5 (severe)] 36 19
Intensity of TEAEs [Grade 5] 1 3
Intensity of TEAEs [Grade 4] 3 2
Intensity of TEAEs [Grade 3] 32 14
Intensity of TEAEs [Grade 2 (moderate)] 28 28
Intensity of TEAEs [Grade 1 (mild)] 5 19
Causality of TEAEs [Drug Related] 54 38
Causality of TEAEs [Not Drug Related] 15 28
TEAEs Leading to Drug Withdrawal 12 3
TEAEs leading to Dose Reduction 16 2
TEAEs leading to Drug Interruption 33 12
TEAEs Leading to Death 1 0
Serious Adverse Event (SAEs) 24 16
Drug Related SAEs 6 2
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)
Adverse Event Reporting Description Non-SAE details: A summary of common (incidence >5%) TEAEs is presented
 
Arm/Group Title Tasquinimod Placebo
Hide Arm/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

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

All-Cause Mortality
Tasquinimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tasquinimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   24/71 (33.80%)   16/70 (22.86%) 
Blood and lymphatic system disorders     
Anaemia  1  1/71 (1.41%)  0/70 (0.00%) 
Cardiac disorders     
Myocardial ischaemia  1  1/71 (1.41%)  1/70 (1.43%) 
Arteriosclerosis coronary artery  1  1/71 (1.41%)  0/70 (0.00%) 
Cardiac failure  1  1/71 (1.41%)  0/70 (0.00%) 
Myocardial infarction  1  1/71 (1.41%)  0/70 (0.00%) 
Pericarditis  1  0/71 (0.00%)  1/70 (1.43%) 
Eye disorders     
Dacryostenosis acquired  1  0/71 (0.00%)  1/70 (1.43%) 
Gastrointestinal disorders     
Vomiting  1  2/71 (2.82%)  1/70 (1.43%) 
Ileus  1  1/71 (1.41%)  1/70 (1.43%) 
Nausea  1  1/71 (1.41%)  1/70 (1.43%) 
Abdominal pain  1  0/71 (0.00%)  1/70 (1.43%) 
Colitis  1  1/71 (1.41%)  0/70 (0.00%) 
Constipation  1  0/71 (0.00%)  1/70 (1.43%) 
Large intestine perforation  1  1/71 (1.41%)  0/70 (0.00%) 
Proctitis  1  1/71 (1.41%)  0/70 (0.00%) 
General disorders     
Fatigue  1  1/71 (1.41%)  1/70 (1.43%) 
Disease progression  1  1/71 (1.41%)  0/70 (0.00%) 
General physical health deterioration  1  0/71 (0.00%)  1/70 (1.43%) 
Pyrexia  1  1/71 (1.41%)  0/70 (0.00%) 
Hepatobiliary disorders     
Biliary cyst  1  1/71 (1.41%)  0/70 (0.00%) 
Infections and infestations     
Urinary tract infection  1  1/71 (1.41%)  1/70 (1.43%) 
Appendicitis perforated  1  0/71 (0.00%)  1/70 (1.43%) 
Bronchitis  1  0/71 (0.00%)  1/70 (1.43%) 
Erysipelas  1  0/71 (0.00%)  1/70 (1.43%) 
Pyelonephritis acute  1  1/71 (1.41%)  0/70 (0.00%) 
Injury, poisoning and procedural complications     
Facial bones fracture  1  0/71 (0.00%)  1/70 (1.43%) 
Fall  1  0/71 (0.00%)  1/70 (1.43%) 
Laceration  1  0/71 (0.00%)  1/70 (1.43%) 
Spinal fracture  1  1/71 (1.41%)  0/70 (0.00%) 
Investigations     
Blood creatinine increased  1  1/71 (1.41%)  0/70 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/71 (2.82%)  0/70 (0.00%) 
Fluid retention  1  1/71 (1.41%)  0/70 (0.00%) 
Musculoskeletal and connective tissue disorders     
Chondrocalcinosis  1  1/71 (1.41%)  0/70 (0.00%) 
Lumbar spinal stenosis  1  1/71 (1.41%)  0/70 (0.00%) 
Muscular weakness  1  1/71 (1.41%)  0/70 (0.00%) 
Pain in extremity  1  1/71 (1.41%)  0/70 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/71 (0.00%)  1/70 (1.43%) 
Metastases to central nervous system  1  0/71 (0.00%)  1/70 (1.43%) 
Nervous system disorders     
Headache  1  1/71 (1.41%)  0/70 (0.00%) 
Loss of consciousness  1  1/71 (1.41%)  0/70 (0.00%) 
Movement disorder  1  1/71 (1.41%)  0/70 (0.00%) 
Paraesthesia  1  1/71 (1.41%)  0/70 (0.00%) 
Polyneuropathy  1  1/71 (1.41%)  0/70 (0.00%) 
Psychiatric disorders     
Delirium  1  1/71 (1.41%)  0/70 (0.00%) 
Depression  1  1/71 (1.41%)  0/70 (0.00%) 
Renal and urinary disorders     
Urinary retention  1  1/71 (1.41%)  1/70 (1.43%) 
Acute kidney injury  1  1/71 (1.41%)  0/70 (0.00%) 
Haematuria  1  0/71 (0.00%)  1/70 (1.43%) 
Renal failure  1  0/71 (0.00%)  1/70 (1.43%) 
Ureteric stenosis  1  0/71 (0.00%)  1/70 (1.43%) 
Urethral stenosis  1  1/71 (1.41%)  0/70 (0.00%) 
Urinary tract pain  1  1/71 (1.41%)  0/70 (0.00%) 
Reproductive system and breast disorders     
Prostatic obstruction  1  0/71 (0.00%)  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  2/71 (2.82%)  0/70 (0.00%) 
Interstitial lung disease  1  1/71 (1.41%)  0/70 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/71 (1.41%)  1/70 (1.43%) 
Circulatory collapse  1  1/71 (1.41%)  0/70 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tasquinimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   69/71 (97.18%)   66/70 (94.29%) 
Blood and lymphatic system disorders     
Anaemia  1  9/71 (12.68%)  2/70 (2.86%) 
Gastrointestinal disorders     
Nausea  1  19/71 (26.76%)  15/70 (21.43%) 
Constipation  1  23/71 (32.39%)  8/70 (11.43%) 
Vomiting  1  9/71 (12.68%)  9/70 (12.86%) 
Diarrhoea  1  9/71 (12.68%)  6/70 (8.57%) 
Abdominal pain  1  9/71 (12.68%)  4/70 (5.71%) 
Flatulence  1  4/71 (5.63%)  3/70 (4.29%) 
Abdominal pain upper  1  4/71 (5.63%)  1/70 (1.43%) 
General disorders     
Fatigue  1  21/71 (29.58%)  15/70 (21.43%) 
Asthenia  1  17/71 (23.94%)  10/70 (14.29%) 
Oedema peripheral  1  13/71 (18.31%)  8/70 (11.43%) 
Pain  1  5/71 (7.04%)  4/70 (5.71%) 
Pyrexia  1  6/71 (8.45%)  3/70 (4.29%) 
Influenza like illness  1  5/71 (7.04%)  0/70 (0.00%) 
Infections and infestations     
Cystitis  1  5/71 (7.04%)  2/70 (2.86%) 
Injury, poisoning and procedural complications     
Fall  1  1/71 (1.41%)  5/70 (7.14%) 
Investigations     
Weight decreased  1  6/71 (8.45%)  1/70 (1.43%) 
Metabolism and nutrition disorders     
Decreased appetite  1  26/71 (36.62%)  8/70 (11.43%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  18/71 (25.35%)  15/70 (21.43%) 
Back pain  1  15/71 (21.13%)  14/70 (20.00%) 
Pain in extremity  1  11/71 (15.49%)  11/70 (15.71%) 
Myalgia  1  5/71 (7.04%)  10/70 (14.29%) 
Bone pain  1  6/71 (8.45%)  5/70 (7.14%) 
Musculoskeletal chest pain  1  6/71 (8.45%)  5/70 (7.14%) 
Musculoskeletal pain  1  7/71 (9.86%)  4/70 (5.71%) 
Spinal pain  1  4/71 (5.63%)  5/70 (7.14%) 
Neck pain  1  4/71 (5.63%)  2/70 (2.86%) 
Nervous system disorders     
Headache  1  8/71 (11.27%)  7/70 (10.00%) 
Paraesthesia  1  6/71 (8.45%)  2/70 (2.86%) 
Peripheral sensory neuropathy  1  8/71 (11.27%)  0/70 (0.00%) 
Dizziness  1  4/71 (5.63%)  3/70 (4.29%) 
Psychiatric disorders     
Insomnia  1  10/71 (14.08%)  6/70 (8.57%) 
Depression  1  4/71 (5.63%)  0/70 (0.00%) 
Renal and urinary disorders     
Urinary retention  1  1/71 (1.41%)  5/70 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/71 (11.27%)  3/70 (4.29%) 
Pleural effusion  1  4/71 (5.63%)  0/70 (0.00%) 
Rhinorrhoea  1  4/71 (5.63%)  0/70 (0.00%) 
Skin and subcutaneous tissue disorders     
Onycholysis  1  4/71 (5.63%)  0/70 (0.00%) 
Vascular disorders     
Hypertension  1  9/71 (12.68%)  6/70 (8.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director, Oncology
Organization: Ipsen
Phone: clinical.trials@ipsen.com
EMail: clinical.trials@ipsen.com
Layout table for additonal information
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