Back to resultsMasitinib Plus Gemcitabine in Pancreatic Cancer
Primary Purpose
Locally Advanced or Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Gemcitabine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic Pancreatic Cancer focused on measuring Pancreatic cancer, tyrosine kinase inhibitor
Eligibility Criteria
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
Sites / Locations
- Hospital AZ Sint-Jan
- Polyclinique de Limoges site CHENIEUX
- Centre Hospitalier de Longjumeau
- General University Hospital of Patras
- Sanjeevani CBCC USA Cancer Hospital
- Omsk Clinical oncology dispensary Omsk
- National Oncology Institute
- Institut Salah Azaiez de Cancerologie
- Center of Surgical Innovations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Masitinib & gemcitabine
Placebo & gemcitabine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Survival rates
The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03766295
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Pancreatic Cancer
Keywords
Pancreatic cancer, tyrosine kinase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
377 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib & gemcitabine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo & gemcitabine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Overall Survival (median)
Description
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.
Time Frame
From day of randomization to death, assessed for a maximum of 60 months
Secondary Outcome Measure Information:
Title
Survival rates
Description
The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
Time Frame
every 24 weeks
Title
Progression Free Survival
Description
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
Time Frame
From day of randomization to disease progression or death, assessed for a maximum of 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joël Ezenfis, MD
Organizational Affiliation
Centre Hospitalier de Longjumeau, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Polyclinique de Limoges site CHENIEUX
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Centre Hospitalier de Longjumeau
City
Longjumeau
ZIP/Postal Code
91160
Country
France
Facility Name
General University Hospital of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Sanjeevani CBCC USA Cancer Hospital
City
Raipur
ZIP/Postal Code
492001
Country
India
Facility Name
Omsk Clinical oncology dispensary Omsk
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
National Oncology Institute
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Institut Salah Azaiez de Cancerologie
City
Bab Saadoun
Country
Tunisia
Facility Name
Center of Surgical Innovations
City
Kiev
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Masitinib Plus Gemcitabine in Pancreatic Cancer
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