Masitinib Plus Gemcitabine in Pancreatic Cancer

Locally Advanced or Metastatic Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766295
• Other study ID #: AB12005
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Masitinib

• Gemcitabine

• Placebo

Locations

Country	Name	City	State
Belgium	Hospital AZ Sint-Jan	Brugge
France	Polyclinique de Limoges site CHENIEUX	Limoges
France	Centre Hospitalier de Longjumeau	Longjumeau
Greece	General University Hospital of Patras	Patras
India	Sanjeevani CBCC USA Cancer Hospital	Raipur
Russian Federation	Omsk Clinical oncology dispensary Omsk	Omsk
Slovakia	National Oncology Institute	Bratislava
Tunisia	Institut Salah Azaiez de Cancerologie	Bab Saadoun
Ukraine	Center of Surgical Innovations	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

Belgium,  France,  Greece,  India,  Russian Federation,  Slovakia,  Tunisia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival rates	The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution	every 24 weeks
Secondary	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