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

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-002-16
• Date of registration: 20/04/2016
• Prospective Registration: No
• Primary sponsor: AB Science,
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 21/03/2016
• Target sample size: 20
• Recruitment status: Pending
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=002-16
• Study type: Interventional
• Study design: Prospective, multicenter, randomized, double-blind, placebo-controlled, two-parallel groups, phase 3 study
• Phase: III

Countries of recruitment

Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Georgia, Germany, Greece, Hungary, India, Italy, Malasya, Mexico, Morocco, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Spain, Taiwan, Thailand, Tunisia, Ukraine, United Kindgdom

Contacts

• Name: Aracely Durand Galvez
• Affiliation: INTRIALS-PERU INVESTIGACIONES CLINICAS S.R.L.

• Name: Aracely Durand Galvez
• Affiliation: INTRIALS-PERU INVESTIGACIONES CLINICAS S.R.L.

Key inclusion & exclusion criteria

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


Age minimum: 18
Age maximum: 100
Gender: --

Health Condition(s) or Problem(s) studied

Pancreas, unspecified

-C259 Pancreas, unspecified
Pancreas, unspecified

C259

Intervention(s)

First randomisation:
549 patients will be randomised in two groups:
• Group 1: Patients will receive masitinib in combination with gemcitabine at 1000mg/m²
• Group 2: Patients will receive placebo in combination with gemcitabine at 1000mg/m²
At first randomisation, patients will be centrally allocated to one of the 2 treatments groups by IWRS according to modified minimisation method (random assignment).
Second randomisation:
We estimate that 60% of the patients (330 patients) will be part of the second randomization.
An estimated 220 patients previously treated by masitinib in combination with gemcitabine who were progressive, or non progressive and having discontinued study for any adverse event not defined as a severe adverse event (grade ≥ 3) due to the mechanism of action of masitinib will be randomised in two groups:
• Group 1A: Patients will receive masitinib+Folfiri.3
• Group 1B: Patients will receive placebo+Folfiri.3
At second randomisation, patients will be centrally allocated to one of the two groups by IWRS according to modified minimisation method (random assignment).

Source(s) of Monetary Support

AB Science

Ethics review

Status: Approved
Approval date: 04/08/2015
Contact:

[e-mail]

Instituto Nacional de Enfermedades Neoplasicas

7106099-3001

[e-mail]