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Masitinib Plus Gemcitabine in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03766295
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
AB Science

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.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Pancreatic Cancer Drug: Masitinib Drug: Gemcitabine Drug: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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: Masitinib
Other Name: AB1010

Drug: Gemcitabine
Other Name: Gemzar

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 Name: Gemzar

Drug: Placebo
Other Name: Placebo Oral Tablet




Primary Outcome Measures :
  1. Overall Survival (median) [ Time Frame: From day of randomization to death, assessed for a maximum of 60 months ]
    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 :
  1. Survival rates [ Time Frame: every 24 weeks ]
    The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution

  2. Progression Free Survival [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766295


Locations
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Belgium
Hospital AZ Sint-Jan
Brugge, Belgium, 8000
France
Polyclinique de Limoges site CHENIEUX
Limoges, France, 87000
Centre Hospitalier de Longjumeau
Longjumeau, France, 91160
Greece
General University Hospital of Patras
Patras, Greece, 26504
India
Sanjeevani CBCC USA Cancer Hospital
Raipur, India, 492001
Russian Federation
Omsk Clinical oncology dispensary Omsk
Omsk, Russian Federation, 644013
Slovakia
National Oncology Institute
Bratislava, Slovakia, 833 10
Tunisia
Institut Salah Azaiez de Cancerologie
Bab Saadoun, Tunisia
Ukraine
Center of Surgical Innovations
Kiev, Ukraine
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Joël Ezenfis, MD Centre Hospitalier de Longjumeau, France

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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT03766295     History of Changes
Other Study ID Numbers: AB12005
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by AB Science:
Pancreatic cancer
tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs