A PROSPECTIVE, MULTICENTER, DOUBLE-RANDOMISED, DOUBLE-BLIND,2-PARALLEL GROUPS, PHASE 3 STUDY TO COMPARE AS FIRST LINE THERAPY EFFICACY AND SAFETY OF MASITINIB IN COMBINATION WITH GEMCITABINE, TO GEMCITABINE IN COMBINATION WITH PLACEBO, FOLLOWED AS SECOND LINE TREATMENT BY MASITINIB IN COMBINATION WITH FOLFIRI 3 VERSUS PLACEBO IN COMBINATION WITH FOLFIRI 3 IN THE TREATMENT OF PATIENTS WITH NON RESECTABLE LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER

Not Applicable

• Conditions: -C259 Pancreas, unspecified; Pancreas, unspecified; C259

• Registration Number: PER-002-16
• Lead Sponsor: AB Science,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-20
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage
2. Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).
OR
Patients with ‘genetic fingerprint of aggressiveness ACOX1 (DCt ≤ 3.05)’
3. Chemotherapy naïve patient for the advanced/metastatic disease
4. Documented decision justifying non eligibility for surgical resection.
5. Patient with measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according to RECIST 1.1
6. Patient with ECOG ≤ 2
7. Patient with adequate organ functions
8. Patient with life expectancy > 3 months
9. Male or female patient, age 18 years
10. Patient with a BMI > 18 kg/m² and >40 kg
11. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test at screening and baseline), 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

Exclusion Criteria

1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
2. Patient with no pain related to the disease (as defined in the inclusion criterion number 2) and no genetic fingerprint of aggressiveness
3. Patient with ECOG ≥ 3
4. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
5. Patient presenting with cardiac disorders defined.
6. 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
7. Pregnant, intent to be pregnant, or nursing female patient

Study & Design

• Study Type: Interventional
• Study Design: Not specified