Clinical trial NCT03766295: Masitinib Plus Gemcitabine in Pancreatic Cancer
Official title: A Prospective, Multicenter, Double-randomized, 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, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Locally Advanced or Metastatic Pancreatic Cancer
Keywords: Pancreatic cancer
tyrosine kinase inhibitor
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pancreatic cancer and who have pain related to the disease.

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 objective of this study is to evaluate the efficacy and safety of masitinib in combination with gemcitabine with respect to placebo in combination with gemcitabine for the treatment of non resectable locally advanced or metastatic pancreatic cancer patients with pain related to the disease. Approximately 330 patients with pain Visual Analogue Scale (VAS) \> 20 and/or treated with 'opioid analgesics' dose ≥ 1 mg/kg/day at baseline will be randomized in a 2:1 ratio to the masitinib and placebo arms, respectively. The primary outcome measure is overall survival (OS).

Eligibility criteria: Main inclusion criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage
2. 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:

1. Patient with no pain related to the disease (as defined in the inclusion criterion number 2)
2. Pregnant or nursing female patient

Primary outcomes:
measure: Overall Survival (median)
timeFrame: From day of randomization to death, assessed for a maximum of 60 months
Secondary outcomes:
measure: Survival rates
timeFrame: every 24 weeks
measure: Progression Free Survival
timeFrame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Hospital AZ Sint-Jan
city: Limoges
country: France
facility: Polyclinique de Limoges site CHENIEUX
city: Longjumeau
country: France
facility: Centre Hospitalier de Longjumeau
city: Patras
country: Greece
facility: General University Hospital of Patras
city: Raipur
country: India
facility: Sanjeevani CBCC USA Cancer Hospital
city: Omsk
country: Russian Federation
facility: Omsk Clinical oncology dispensary Omsk
city: Bratislava
country: Slovakia
facility: National Oncology Institute
city: Bab Saadoun
country: Tunisia
facility: Institut Salah Azaiez de Cancerologie
city: Kiev
country: Ukraine
facility: Center of Surgical Innovations
Study officials:
affiliation: Centre Hospitalier de Longjumeau, France
name: Joël Ezenfis, MD
role: PRINCIPAL_INVESTIGATOR
References: