Status:
COMPLETED
Masitinib Plus Gemcitabine in Pancreatic Cancer
Lead Sponsor:
AB Science
Conditions:
Locally Advanced or Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pa...
Detailed Description
Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage
- Patient with pain related to the disease, as assessed by the investigator and the patient:
- Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline.
- Pain, as assessed by the patient is defined as at least one value out of two values \> 20mm on Visual Analogue Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value).
- OR
- \- Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).
- 3\. Chemotherapy naïve patient for the advanced/metastatic disease
- Main exclusion criteria:
- Patient with no pain related to the disease (as defined in the inclusion criterion number 2)
- Pregnant or nursing female patient
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT03766295
Start Date
July 1 2014
End Date
December 1 2020
Last Update
December 8 2020
Active Locations (9)
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1
Hospital AZ Sint-Jan
Bruges, Belgium, 8000
2
Polyclinique de Limoges site CHENIEUX
Limoges, France, 87000
3
Centre Hospitalier de Longjumeau
Longjumeau, France, 91160
4
General University Hospital of Patras
Pátrai, Greece, 26504