Study to evaluate 2 types of treatment as first line treatment (masitinib + docetaxel or placebo + docetaxel ) in the treatment of patients with metastatic Castrate Resistant Prostate Cancer (mCRPC)

• Register: EUCTR
• Last refreshed on: 5 December 2016
• Main ID: EUCTR2013-000809-23-ES
• Date of registration: 26/03/2014
• Prospective Registration: Yes
• Primary sponsor: AB Science
• Public title: Study to evaluate 2 types of treatment as first line treatment (masitinib + docetaxel or placebo + docetaxel ) in the treatment of patients with metastatic Castrate Resistant Prostate Cancer (mCRPC)
• Scientific title: A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC)
• Date of first enrolment: 10/10/2014
• Target sample size: 550
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000809-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Canada, China, Czech Republic, Greece, Hong Kong, Hungary, India, Italy, Korea, Republic of, Malaysia, Mexico, Morocco, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Tunisia, Ukraine, United Kingdom, United States

Contacts

• Name: Beatrice Martin
• Affiliation: AB Science

• Name: Beatrice Martin
• Affiliation: AB Science

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient aged = 18 years old, with histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone < 0.5ng/ml) with one of the following criteria:
- Pre-treated with abiraterone with progressed disease documented, OR
- with indication for initiating docetaxel administration (e.g., widespread visceral disease or rapidly progressive disease).

2. Patient with evidence of progressive metastatic disease. Disease progression at trial enrolment is based on progression in at least one variable described in Table 5.
3. Patient with ECOG ? 1
4. Patient with adequate organ function:
? Absolute neutrophil count (ANC) ? 1.5 x 10ç/L
? Haemoglobin ? 10 g/dL
? Platelets (PTL) ? 75 x 109/L
? AST/ALT ? 3x ULN
? Gamma GT ?2.5 x ULN
? Bilirubin ? 1.5x ULN
? Normal creatinine or if abnormal creatinine, creatinine clearance ? 50 mL/min (Cockcroft and Gault formula)
? Albumin > 1 x LLN
? Proteinuria < 30 mg/dL (1+) on the dipstick; in case of proteinuria ? 1+ on the dipstick, 24 hours proteinuria must be ? 1.5g/24h
5. Patient with life expectancy > 6 months
6. Patient with BMI > 18 and patient weight > 40 kg
7. Man who agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for three months after the last treatment intake
8. Patient able and willing to comply with study procedures as per protocol
9. 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.
10. 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion criteria:
1. Patient who has been previously treated with chemotherapy.
2. Patient with bone marrow irradiation > 40% within 12 months before baseline
3. Patient treated for a cancer other than prostate cancer within 3 years before enrollment, with the exception of basal cell carcinoma (and pTa or pT1)
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:
o Acute coronary syndrome
o Acute heart failure (class III or IV of the NYHA classification)
o 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 an history of poor compliance or an 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. Patient under treatment with any anti-tumour therapy (any radiotherapy, chemotherapy, biologic or anti-androgen therapy except GnRH/LHRH analogs)


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

metastatic Castrate Resistant Prostate Cancer (mCRPC).

Intervention(s)

Product Name: masitinib 100mg
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Masitinib mesylate
CAS Number: 790299-79-5
Current Sponsor code: AB1010
Other descriptive name: MASITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: masitinib 200mg
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Masitinib Mesylate
CAS Number: 790299-79-5
Current Sponsor code: AB1010
Other descriptive name: MASITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Date of documented death

Primary end point(s): ? Overall Survival (OS) is defined as the time from the randomization to the date of documented death

Secondary Objective: Secondary endpoint
? Survival rate every 6 months
? Overall Progression Free Survival (PFS)
? PFS rate every 12 weeks
? Overall Time To Progression (TTP)
? TTP rate every 12 weeks
? Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks
? Decline of PSA level ? 30% from baseline at time point
? Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire
o Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ)
o Analgesic intake
o ECOG Performance Status
o Pain improvement (VAS)
? Pharmacogenomic assessment: Relationship between genomic data and overall survival.
? Safety profile using the NCI CTCAE v4.03 classification

Main Objective: Overall survival (OS)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Every 12 weeks

Secondary end point(s): ? Survival rate every 6 months
? Overall Progression Free Survival (PFS)
? PFS rate every 12 weeks
? Overall Time To Progression (TTP)
? TTP rate every 12 weeks
? Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks
? Decline of PSA level ? 30% from baseline at time point
? Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire
o Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ)
o Analgesic intake
o ECOG Performance Status
o Pain improvement (VAS)
? Pharmacogenomic assessment: Relationship between genomic data and overall survival.
? Safety profile using the NCI CTCAE v4.03 classification

Secondary ID(s)

AB12003

Source(s) of Monetary Support

AB Science