Health Condition 1: null- Patients with metastatic colorectal cancer
Conditions
Interventions
Intervention1: Masitinib, FOLFIRI: Masitinib will be taken orally, daily at 6mg/kg/day. FOLFIRI will be administered every 2 weeks
Control Intervention1: Placebo, FOLFIRI: Placebo will be taken orally
Sponsors
AB Science
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible the patient must fulfil all the following inclusion criteria: 1. Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum 2. Metastatic disease not amenable to surgical resection with curative intent 3. Patient in second line treatment after progression according to RECIST criteria following administration of a standard chemotherapy regimen for treatment of metastatic disease 4. Patient with measurable lesions according to RECIST criteria (version 1.1) with spiral CT scan and defined as ³10 mm in longest diameter and 2X the slice thickness for extra nodal lesions and/or >15 mm in short axis diameter for nodal lesions 5. Patient eligible for a standard second line therapy with FOLFIRI 6. Patient with ECOG 7. Patient with adequate organ function · Absolute neutrophils count (ANC) >= 1.5 x 109/L · Haemoglobin >= 10 g/dl · Platelets (PLT) >= 75 x 109/L · AST/ALT · GammaGT · Bilirubin · Normal Creatinine or if abnormal creatinine, creatinine clearance >= 50 mL/min (Cockcroft and Gault formula) · Albumin > 1 x LLN · Proteinuria = 1+ on the dipstick, 24 hours proteinuria must be 8. Patient with life expectancy > 3 months 9. Female or male patient >= 18 10. Patient weight >40 kg and BMI > 18 11. Man and woman of childbearing potential, 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 3 months after the last treatment intake 12. Female patient of childbearing potential must have a negative pregnancy test at screening and baseline 13. Patient able and willing to comply with study procedures as per protocol 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. 15. 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.
Exclusion criteria
Exclusion criteria: 1. Patient intolerant to one of these treatments: irinotecan, 5-fluorouracil (5-FU), folinic acid 2. More than 1 prior chemotherapy regimens for metastatic colorectal cancer. 3. Pregnant, intent to be pregnant, or nursing female patient 4. Patient with any chronic inflammatory bowel disease 5. Patient treated for a cancer other than colorectal cancer within five years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ 6. Patient required to receive other therapy than FOLFIRI for second line metastatic colorectal cancer 7. Patient with an hepatic involvement > 50% 8. Patient with active central nervous system metastasis or history of CNS metastases 9. Patient with an active infection (Human immunodeficiency virus infection and/or hepatitis B or C infection â?¦) 10. 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 11. Patient with a history of poor compliance or of drug/alcohol abuse, or excessive alcohol beverage consumption, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: till death or last follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response RateTimepoint: every 8 weeks;PFS rateTimepoint: every 8 weeks;Survival RateTimepoint: every 6 months;TTP rateTimepoint: every 8 weeks | — |
Countries
Canada, China, Czech Republic, France, Greece, Hong Kong, Hungary, India, Malaysia, Philippines, Romania, Singapore, Slovakia, South Africa, Spain, Taiwan, Tunisia, United Kingdom, United States of America
Contacts
Public ContactJhansi Reddy
Maya Clinicals Drug Development Pvt. Ltd.
Outcome results
None listed