A controlled study in patients with gastro-intestinal stromal tumour who require first line therapy. Patients receiving masitinib will be compared to patients receiving imatinib.
- Conditions
- Patients with advanced, metastatic or unresectable gastro-intestinal stromal tumour (GIST).MedDRA version: 18.1Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-000973-40-GB
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
1. Histologically proven, metastatic or locally advanced non resectable, or recurrent post surgery GIST
2. Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
3. Measurable tumour lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according to RECIST criteria
4. C-Kit (CD117) positive tumours detected immuno-histochemically or PDGFR positive if c-Kit negative
5. ECOG = 1
6. Patient with adequate organ function:
- absolute neutrophil count (ANC) = 1.5 x 10e9/L
- Haemoglobin = 10 g/dL
- platelets (PTL) = 75 x 10e9/L
- AST and ALT = 3x ULN (= 5 x ULN in case of liver metastases)
- Gamma GT = 2.5 x ULN (= 5 x ULN in case of liver metastases)Bilirubin = 1.5x ULN (= 3 x ULN in case of liver metastases)
- Normal Creatinine or if abnormal Creatinine, Creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- albumin > 1 x LLN
- proteinuria < 30 mg/dL on the dipstick; if proteinuria = 30 mg/dL, 24 hours proteinuria = 1.5g/24 hours
7. Patient with life expectancy > 6 months
8. Men or women, age >18 years
9. Contraception:
- Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an acceptable method of contraception by her male partner during the study and for 3 months after the last treatment intake.
- 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
10. Patient should be able and willing to comply with study procedures as per protocol.
11. Patient should be able to understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures.
12. 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.
13. Patient weight > 40 kg and BMI > 18 kg/m²
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subj
1. Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 2
2. Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
3. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
4. 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 judgment of the investigator, or symptomatic hypertension
5. Patient with history of poor compliance or 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
6. Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events
- Previous treatment
7. Treatment with any investigational agent within 4 weeks prior baseline
8. Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method