Metastatic Castrate Resistant Prostate Cancer (mCRPC). MedDRA version: 19.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: masitinib
Product Code: AB1010
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: masitinib, mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive na
Sponsors
AB Science
Eligibility
Sex/Gender
Male
Inclusion 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 1 x LLN - Proteinuria 3 months 6. Patient with BMI > 18 kg/m2 and weight > 40 kg 7. Contraception ? Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake or who agrees to use an acceptable method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake. ? Highly effective methods of contraception include: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable - Intrauterine device (IUD) - Intrauterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Vasectomized male (azoospermia assessed medically) - Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient) ? Acceptable methods of contraception include: - Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action - Male or female condom with or without spermicide - Cap, diaphragm, or sponge with spermicide 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 Are the trial subjects under 18? no Number of subjects
Exclusion criteria
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) WASH OUT • Known hypersensitivity to masitinib or to any of the excipients • Patients with any investigational agent within 4 weeks prior to baseline • Patients with an active infection requiring antibiotics within 14 days prior to registrationbaseline • Patient treated with warfarin and presenting with an INR (International Normalized Ratio) above 2 or an aPTT (activated partial thromboplastin time) above 1.2 ILN • SixFour weeks prior to baseline for anti-androgens (ex. bicalutamide) and 5-alpha reductase inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Key Secondary endpoint • Overall Survival (OS) Secondary endpoint • PFS rate at 6,9,12 months based on Kaplan-Meier estimate of PFS distribution • OS rate at 12,15,18 months based on Kaplan-Meier estimate of OS distribution • 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 12 weeks or later • Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire - Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ) - Analgesic intake - ECOG Performance Status -Pain improvement (VAS) • Pharmacogenomic assessment: Relationship between genomic data and overall survival. • Safety profile using the NCI CTCAE v4.03 classification;Main Objective: The objective of the trial is to demonstrate the efficacy and evaluate safety of masitinib in combination with docetaxel and prednisone to placebo in combination with docetaxel and prednisone in first line metastatic Castrate Resistant Prostate Cancer (mCRPC). Primary endpoint • Progression Free Survival (PFS) ;Primary end point(s): • Progression Free Survival (PFS) Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of documented progression or any cause of death during the study. ;Timepoint(s) of evaluation of this end point: Date of documented progression or any cause of death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary endpoint • Overall Survival (OS) Secondary endpoint • PFS rate at 6,9,12 months based on Kaplan-Meier estimate of PFS distribution • OS rate at 12,15,18 months based on Kaplan-Meier estimate of OS distribution • 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 12 weeks or later • Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire - Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ) - Analgesic intake - ECOG Performance Status - Pain improvement (VAS) • Pharmacogenomic assessment: Relationship between genomic data and overall survival. • Safety profile using the NCI CTCAE v4.03 classification ;Timepoint(s) of evaluation of this end point: As defined above per secondary endpoint(s) | — |
Countries
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
Public ContactDenys ZAITSEV
AB Science
Outcome results
None listed