A phase 3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients with metastatic colorectal cancer
- Conditions
- Health Condition 1: null- Patients with metastatic colorectal cancer
- Registration Number
- CTRI/2015/10/006331
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 2
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 <= 2
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 <= 3 x ULN (<= 5 x ULN in case of liver metastases)
· GammaGT <= 2.5 x ULN (<= 5 x ULN in case of liver metastases)
· Bilirubin <= 1.5 x 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. If proteinuria is >= 1+ on the dipstick, 24
hours proteinuria must be < 1.5g/24 hours
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method