Study to evaluate 2 types of treatment (masitinib + FOLFIRI or placebo + FOLFIRI) in the treatment of patients with metastatic colorectal cancer that have received 1 previous therapy

Phase 1

• Conditions: Metastatic colorectal cancer after 1 previous line of treatment; MedDRA version: 18.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000490-79-GR
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-30
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 574

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 ?10 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 (= 3 x ULN in case of liver metastasis)
• 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 kg/m2
11. Contraception
• Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two highly effective 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. these include:
- A documented placement of an intrauterine device (IUD) or system (IUS) and the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository)
- Documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal should also be used
- Double barrier method: condom and occlusive cap with spermicidal
- Any other contraceptive method with a documented failure rate of <1% per year
- Abstinence when this is in line with the preferred and usual lifestyle of the patient.
• Male patients must use two highly effective 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. These are as follows:
- Condom and occlusive cap with spermicidal
- Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method used with spermicidal
- If his female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants, in addition a barrier method used with spermicidal foam should also be used.
- Medically prescribed topically-applied transdermal contraceptive patch and a barrier method used with spermicidal
- If his female partner has undergone documented tubal ligation (female sterilization), in addition a barrier method used with spermicidal should also be used.
- If his female partner has undergone documented placement of an intrauterine device (IUD) or system (IUS), in

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 (CNS) metastasis or history of CNS metastases
9. Patient with an active infection (Human immunodeficiency virus infection and/or hepatitis B or C infection …)
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
WASH OUT
12. Any previous treatment with an investigational agent or chemotherapy or biological agent will require a wash-out period of four weeks prior to baseline.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified