Masitinib Plus Gemcitabine in Pancreatic Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: Gemcitabine; Drug: Placebo; Drug: Masitinib

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).

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Hospital AZ Sint-Jan
• France
  • Limoges, France, 87000
    • Polyclinique de Limoges Site Chenieux
  • Longjumeau, France, 91160
    • Centre Hospitalier de Longjumeau
• Greece
  • Patras, Greece, 26504
    • General University Hospital of Patras
• India
  • Raipur, India, 492001
    • Sanjeevani CBCC USA Cancer Hospital
• Russian Federation
  • Omsk, Russian Federation, 644013
    • Omsk Clinical oncology dispensary Omsk
• Slovakia
  • Bratislava, Slovakia, 833 10
    • National Oncology Institute
• Tunisia
  • Bab Saadoun, Tunisia
    • Institut Salah Azaiez de Cancerologie
• Ukraine
  • Kiev, Ukraine
    • Center of Surgical Innovations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Masitinib & gemcitabine; Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.	Drug: Gemcitabine; Other Names: Gemzar; Drug: Masitinib; Other Names: AB1010
Active Comparator: Placebo & gemcitabine; Participants receive matching placebo, given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.	Drug: Gemcitabine; Other Names: Gemzar; Drug: Placebo; Other Names: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (median)	Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.	From day of randomization to death, assessed for a maximum of 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rates	The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution	every 24 weeks
Progression Free Survival	Progression Free Survival (PFS) is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria	From day of randomization to disease progression or death, assessed for a maximum of 60 months

Collaborators and Investigators

• Sponsor: AB Science
• Investigators: Principal Investigator: Joël Ezenfis, MD, Centre Hospitalier de Longjumeau, France

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: tyrosine kinase inhibitor; Pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: AB12005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes