Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001038-32 | EudraCT Number |
Not provided
Not provided
Not provided
Development of tasquinimod in prostate cancer discontinued
Not provided
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The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tasquinimod | Experimental | 1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg or 1 mg per day) until disease progression or toxicity or patient's willingness to stop. |
|
| Placebo | Placebo Comparator | 1 capsule daily, taken orally with water and food until disease progression or toxicity or patient's willingness to stop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasquinimod | Drug | A patient's dose will escalate from one level to the next, once tolerability of the current dose is established. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Radiological Progression Free Survival [PFS] | 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. | Every 8 weeks until disease progression documentation (approximately up to 2.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Based on Number of Subjects Who Died | 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 | Every 3 months after study treatment stop until death (approximately up to 2.5 years) |
Not provided
Inclusion Criteria:
Note: PSA value can be rounded to the nearest whole number if PSA>10 ng/mL. If the PSA3 value is above the PSA2, a fourth PSA test will be performed. The PSA4 value should be below or equal to PSA2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Maria Middelares | Ghent | Belgium | ||||
| UZ Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29059273 | Derived | Fizazi K, Ulys A, Sengelov L, Moe M, Ladoire S, Thiery-Vuillemin A, Flechon A, Guida A, Bellmunt J, Climent MA, Chowdhury S, Dumez H, Matouskova M, Penel N, Liutkauskiene S, Stachurski L, Sternberg CN, Baton F, Germann N, Daugaard G. A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy. Ann Oncol. 2017 Nov 1;28(11):2741-2746. doi: 10.1093/annonc/mdx487. |
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A total of 219 patients were screened and 144 patients were randomised.
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)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tasquinimod | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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Not provided
| Placebo | Drug | 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 |
|
| Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2) | 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. | Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years) |
| Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death | 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 | Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years) |
| Time to Further Anticancer Treatment for Prostate Cancer | Time from randomisation to further treatment for prostate cancer | Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years) |
| Time to Deterioration in Functional Assessment of Cancer Therapy - Prostate (FACT-P) | 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) | Up to End of Study visit (approximately up to 2.5 years) |
| Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score | 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" | Baseline and End-of-study Visit (approximately up to 2.5 years) |
| Safety Profile of Tasquinimod | Number of subjects 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) |
| Ghent |
| Belgium |
| Leuven | Belgium |
| Roeselare | Belgium |
| Prague | Hradčany | Czechia |
| Prague | Libeň | Czechia |
| Brno | Czechia |
| Olomouc | Czechia |
| Prague | Czechia |
| Aalborg | Denmark |
| Aarhus | Denmark |
| Copenhagen | Denmark |
| Herlev | Denmark |
| Angers | France |
| Bordeaux | France |
| Clermont-Ferrand | France |
| Dijon | France |
| Lille | France |
| Besancon | Lyon | France |
| Centre Leon Berard | Lyon | France |
| Hopital Edouard Herriot | Lyon | France |
| Paris | France |
| Saint-Herblain | France |
| Toulouse | France |
| Villejuif | France |
| Aachen | Germany |
| Essen | Germany |
| München | Germany |
| Nürtingen | Germany |
| Tübingen | Germany |
| Bajcsy-Zsilinszky Kórház | Budapest | Hungary |
| Országos Onkológia Intézet | Budapest | Hungary |
| Uzsoki utcai Kórház | Budapest | Hungary |
| Genova | Italy |
| Milan | Italy |
| Modena | Italy |
| Pavia | Italy |
| Roma | Italy |
| Rozzano | Italy |
| Torino | Italy |
| Kaunas | Lithuania |
| Vilnius | Lithuania |
| Gdansk | Poland |
| Gdynia | Poland |
| Olsztyn | Poland |
| Urology and Urological Oncology Department and Clinic | Wroclaw | Poland |
| Wojewódzki Szpital Specjalistyczny we Wrocławiu | Wroclaw | Poland |
| Hospital Clinic Vllarroel | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Valle de Hebrón | Barcelona | Spain |
| Elche | Spain |
| Sabadell | Spain |
| Valencia | Spain |
| Leeds | United Kingdom |
| Guy's & St Thomas NHS Foundation | London | United Kingdom |
| The Royal Marsden NHS Trust | London | United Kingdom |
| University College Hospitals London | London | United Kingdom |
| Sutton | United Kingdom |
| FG001 | Placebo | 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 |
| Ongoing in Treatment Period:Data Cut-off |
|
| Withdrawn During Treatment:Data Cut-off |
|
| Ongoing Treatment Period:Final Analysis |
|
| Withdrawn During Treatment:Final Analysi |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tasquinimod | 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 |
| BG001 | Placebo | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Ethnicity | Number | participants |
| ||||||||||||||||
| ECOG Performance Status Score | 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 | Number | participants |
| |||||||||||||||
| Region | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Radiological Progression Free Survival [PFS] | 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. | Intention to treat (ITT) Population | Posted | Median | 90% Confidence Interval | weeks | Every 8 weeks until disease progression documentation (approximately up to 2.5 years) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Based on Number of Subjects Who Died | 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 | ITT Population | Posted | Number | participants | Every 3 months after study treatment stop until death (approximately up to 2.5 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2) | 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. | ITT Population | Posted | Median | 90% Confidence Interval | weeks | Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death | 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 | ITT Population | Posted | Number | participants | Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Further Anticancer Treatment for Prostate Cancer | Time from randomisation to further treatment for prostate cancer | ITT population | Posted | Median | 90% Confidence Interval | weeks | Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration in Functional Assessment of Cancer Therapy - Prostate (FACT-P) | 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 | Posted | Median | 90% Confidence Interval | weeks | Up to End of Study visit (approximately up to 2.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score | 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" | ITT population | Posted | Median | Inter-Quartile Range | Score on scale | Baseline and End-of-study Visit (approximately up to 2.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety Profile of Tasquinimod | 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 | Posted | Number | participants | At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years) |
|
|
At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)
Non-SAE details: A summary of common (incidence >5%) TEAEs is presented
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tasquinimod | 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 | 24 | 71 | 69 | 71 | ||
| EG001 | Placebo | 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 | 16 | 70 | 66 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Movement disorder | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Biliary cyst | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Oncology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| C516109 | tasquinimod |
Not provided
Not provided
Not provided
| 66 to ≤ 75 years |
|
| > 75 years |
|
| Male |
|
| Caucasian/White |
|
| Multiple Race |
|
| Missing |
|
| Belgium |
|
| Hungary |
|
| Denmark |
|
| Poland |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Lithuania |
|
| Germany |
|
| Spain |
|
| Not Hispanic or Latino |
|
| Missing |
|
| 1 (Restricted Activity) |
|
| Missing |
|
| Western Europe |
|
Unstratified[b]
| Log Rank |
| =0.0344 |
| Superiority or Other (legacy) |
|
|
|
|
|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|