A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate the efficacy and safety of masitinib in combination with 5-fluorouracil (5-FU) or capecitabine, or masitinib in combination with irinotecan, or masitinib in combination with irinotecan, 5-fluorouracil (5-FU) and folinic acid (FOLFIRI protocol), as second line chemotherapy in patients with gastric or gastro-oesophageal junction metastatic adenocarcinoma.

Phase 1

• Conditions: gastric or gastro-oesophageal junction metastatic adenocarcinoma; MedDRA version: 12.1 Level: PT Classification code 10063916 Term: Metastatic gastric cancer; MedDRA version: 12.1 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer

• Registration Number: EUCTR2010-022793-14-FR
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 57

Inclusion Criteria

1. Patient with histologically or cytologically advanced-stage, recurrent adenocarcinoma of the stomach or gastro-oesophageal junction (unresectable, and/or metastatic)
2. Patient has failed to one prior cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given > 4 weeks prior to baseline. Failure is defined either by progression of disease or by significant toxicity that precludes further treatment.
3. Patient has recovered of all acute toxic side effects of prior therapy or surgical procedures to grade = 1 National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE v4.02), except for the laboratory values
4. Patient is at least 4 weeks from any major surgery (at baseline)
5. Patient is eligible for a second line treatment with 5-fluorouracil (5-FU) or capecitabine, or irinotecan, or irinotecan, 5-fluorouracil (5-FU) and folinic acid (FOLFIRI protocol)
6. Patient has at least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST).
7. ECOG Performance status = 2
8. Patient with Karnofsky Performance Status (KPS) = 70
9. Patient with adequate organ function:
• Absolute Neutrophil Count (ANC) = 1.5 x 109/L
• Haemoglobin = 10 g/dL
• Platelets (PTL) = 100 x 109/L
• AST/ALT = 5 x ULN
• Gamma-GT = 5 x ULN
• Bilirubin = 3x ULN
• Creatinin clearance = 50 mL/min (Cockcroft and Gault formula)
• Albumin > LLN
• Urea = 2 x ULN
• Proteinuria < 30 mg/dL; in case of proteinuria = 30 mg/dL on the dipstick, 24 hours proteinuria < 1.5g/24 hours
10. Male or female = 18 years
11. Patient with life expectancy = 6 months
12. Patient weight > 40 kg and BMI > 18
13. Man and woman who childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), agrees 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.
14. Patient is able and willing to comply with study visits and procedures as per protocol
15. Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed
16. Patient affiliated to a social security regimen

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient must not be enrolled if he/she fulfils one of the following exclusion criteria:
1.Patient intolerant to 5-fluorouracil (5-FU) or capecitabine or irinotecan or FOLFIRI protocol
2.Patient previously treated with more than one prior systemic regimen for the treatment of gastric cancer including chemotherapy and targeted anticancer therapy (including masitinib and other Tyrosine Kinase inhibitors)
3.Patient who had systemic chemotherapy within 4 weeks before baseline
4.Patient who had radiotherapy within 4 weeks before baseline
5.Patient who had major surgery within 4 weeks before the start of study treatment (laparotomy, line placement is not considered major surgery)
6.Patient who had have not recovered from prior treatments
7.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
8.Pregnant or nursing female patient
9.Patient presenting at least a grade II peripheral neuropathy
10.Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
11.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
•Previous treatment
12.Patient treated with any investigational agent within 4 weeks prior baseline

Study & Design

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