Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 April 2016 |
Main ID: |
EUCTR2013-002293-41-GB |
Date of registration:
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21/06/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A specially designed study at many medical sites to compare whether Masitinib in combination with a currently available medicines which are used for first line & second line treatments, namely gemcitabine or with a currently available series of medicinal treatments (called Folfiri 3), is effective and safe for the treatment of certain types of pancreatic cancer which cannot be removed or is spreading in the body.
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Scientific title:
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A prospective, multicenter, double-randomised, double-blind, 2-parallel groups, phase 3 study to compare as first line therapy efficacy and safety of masitinib in combination with gemcitabine, to gemcitabine in combination with placebo, followed as second line treatment by masitinib in combination with Folfiri 3 versus placebo in combination with Folfiri 3 in the treatment of patients with non resectable locally advanced or metastatic pancreatic cancer - AB12005 |
Date of first enrolment:
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16/09/2014 |
Target sample size:
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549 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002293-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Study is double-randomised with two parallel groups
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 4
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Phase:
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Countries of recruitment
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Argentina
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Austria
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Belgium
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Brazil
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Canada
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China
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Czech Republic
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Germany
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Greece
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Hong Kong
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Hungary
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India
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Korea, Republic of
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Malaysia
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Mexico
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Morocco
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Peru
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Philippines
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Poland
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Romania
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Russian Federation
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Singapore
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Slovakia
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South Africa
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Spain
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Tunisia
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Study Project Manager
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Address:
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3 Avenue George V
75008
Paris
France |
Telephone:
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+ 33 147 20 66 23 |
Email:
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elena.radu@ab-science.com |
Affiliation:
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AB Science |
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Name:
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Clinical Study Project Manager
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Address:
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3 Avenue George V
75008
Paris
France |
Telephone:
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+ 33 147 20 66 23 |
Email:
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elena.radu@ab-science.com |
Affiliation:
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AB Science |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the pancreas 2. Patient with pain related to the disease, as assessed by the investigator and the patient: - Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline. - Pain, as assessed by the patient is defined as at least one value out of two values > 5mm on Visual Analogic Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value). OR Patient treated with opioid analgesics at a dose = 1 mg/kg/day (morphinic equivalent). OR Patients with ‘genetic fingerprint of aggressiveness’: 3. Chemotherapy naïve patient for the advanced/metastatic disease 4. Documented decision justifying non eligibility for surgical resection. 5. Patient with measurable tumor lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according to RECIST 1.1 6. Patient with ECOG = 1 7. Patient with adequate organ functions: -Absolute neutrophils count (ANC) = 1.5 x 109/L - Haemoglobin = 10 g/dL - Platelets (PTL) = 75 x 109/L - AST/ALT = 5 x ULN - Gamma GT = 5 x ULN - Bilirubin = 3 x ULN - Normal Creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula) - Albumin > 1x LLN - Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours - Patient with life expectancy > 3 months 8. Male or female patient, age =18 years 9. Patient with a BMI > 18 kg/m² and >40 kg 10. Male patient or female patient of childbearing potential must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception (with failure rate < 1%) during the study and for 3 months after the last treatment intake. 11. Female patient of childbearing potential must have a negative pregnancy test at screening and baseline. 12.Patient able and willing to comply with study procedures as per protocol. 13. Patient able to understand the patient card and to follow the patient card procedures, in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity during the first 2 months of treatment. 14. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 449 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria: 1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ 2. Patient with no pain related to the disease (as defined in the inclusion criterion number 2) and no genetic fingerprint of aggressiveness 3. Patient with ECOG = 2 4. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis 5. Patient presenting with cardiac disorders defined by at least one of the following conditions: Patient with recent cardiac history (within 6 months) of: - Acute coronary syndrome - Acute heart failure (class III or IV of the NYHA classification) - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) Patient with cardiac failure class III or IV of the NYHA classification Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) Syncope without known aetiology within 3 months Uncontrolled severe hypertension according to the judgement of the investigator, or symptomatic hypertension 6. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent 7. Pregnant, intent to be pregnant, or nursing female patient.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Non-resectable locally advanced or metastatic pancreatic cancer. MedDRA version: 17.0
Level: PT
Classification code 10033610
Term: Pancreatic carcinoma metastatic
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: Masitinib mesylate Product Code: AB1010 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Masitinib mesylate CAS Number: 790-299-79-5 Other descriptive name: MASITINIB MESYLATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 119.3-238.5 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Overall survival (OS)
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Secondary Objective: To compare efficacy and safety of masitinib in combination with Folfiri.3 to placebo in combination with Folfiri.3, in the treatment of patients previously treated by masitinib in combination with gemcitabine who were progressive, or non progressive and having discontinued study for any adverse event not defined as a severe adverse event (grade = 3) due to the mechanism of action of masitinib.
During this study, a pharmacogenomic study will be performed in order to confirm or define predictive criteria of overall survival from genomic data.
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Timepoint(s) of evaluation of this end point: Defined as time from first randomisation to date of documented death.
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Main Objective: To compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with advanced/metastatic pancreatic cancer.
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Secondary Outcome(s)
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Secondary end point(s): 1 Survival rate is defined as the rate of patients alive at each time point. 2. Overall Progression Free Survival (PFS) is defined as the delay between the date of randomization to the date of documented progression or any cause of death during the study. 3. PFS rate is defined as the rate of patients without progression or death at each time point. Progression is assessed by CT scan. 4. Overall Time to progression (TTP) is defined as the time from the date of randomization to the date of documented progression. 5. TTP rate is defined as the rate of patients without documented progression. 6. Best Response is defined as the best response from baseline (CR or PR or SD or PD) assessed by CT Scan. 7. Best Response rate is defined as the number of patients achieving the Best Response divided by the total number of patients in the population of analysis. 8. Change in percentage and in absolute value for the level of serum CA 199 between baseline and at each time point.
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Timepoint(s) of evaluation of this end point: Survival rate every 24 weeks. Progression Free Survival (PFS) every 8 weeks. Quality of life assessments every 4 weeks until week 48 then every 8 weeks.
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Secondary ID(s)
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2013-002293-41-CZ
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AB12005
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Source(s) of Monetary Support
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AB Science
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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