Clinical Trials List
Protocol NumberAB12006
2013-12-01 - 2016-12-31
Phase III
Terminated5
ICD-10C18.9
Malignant neoplasm of colon, unspecified
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 FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients with metastatic colorectal cancer
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Trial Applicant
ClinActis Pte Ltd
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Sponsor
AB Science
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Tao-Wei Ke Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- JENG-FONG CHIOU Division of Radiation Therapy
- 夏和雄 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Colorectal cancer
Objectives
PRIMARY OBJECTIVE
The objective is to compare the overall survival (OS) defined as the time from the randomization to
the date of documented death, of masitinib at 6mg/Kg/day in combination with standard therapy
FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) to matching placebo in combination with
standard therapy FOLFIRI in second line treatment of patients with metastatic colorectal cancer.
SECONDARY OBJECTIVES
The objective is to compare the efficacy (Progression Free Survival), the safety and the quality of life
of masitinib at 6mg/Kg/day in combination with standard therapy FOLFIRI (irinotecan, 5-fluorouracil
and folinic acid) to matching placebo in combination with standard therapy FOLFIRI in second line
treatment of patients with metastatic colorectal cancer.
Test Drug
Masitinib
Active Ingredient
Masitinib
Dosage Form
tablet
Dosage
100 mg 和 200 mg
Endpoints
Primary endpoint
Overall survival (OS)
Secondary endpoints
• Survival rate every 6 months
• Tumor assessment
- Overall Progression Free Survival (PFS)
- PFS rate every 8 weeks
- Overall Time To Progression (TTP)
- TTP rate every 8 weeks
- Best response rate, Objective response rate (CR + PR) and Disease control rate (CR +
PR + SD) every 8 weeks
• Quality of life assessment at week every 8 weeks
- ECOG Performance Status
- Quality of Life according to the EORTC QLQ-C30
- Analgesic intake
- Pain improvement (VAS)
• Pharmacogenomic assessment (Relationship between genomic data and overall survival)
• Safety profile using the NCI CTCAE v4.02 classification
Overall survival (OS)
Secondary endpoints
• Survival rate every 6 months
• Tumor assessment
- Overall Progression Free Survival (PFS)
- PFS rate every 8 weeks
- Overall Time To Progression (TTP)
- TTP rate every 8 weeks
- Best response rate, Objective response rate (CR + PR) and Disease control rate (CR +
PR + SD) every 8 weeks
• Quality of life assessment at week every 8 weeks
- ECOG Performance Status
- Quality of Life according to the EORTC QLQ-C30
- Analgesic intake
- Pain improvement (VAS)
• Pharmacogenomic assessment (Relationship between genomic data and overall survival)
• Safety profile using the NCI CTCAE v4.02 classification
Inclution 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
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.
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
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.
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.
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.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
550 participants
