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Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Placebo
Gemcitabine
Sponsored by
AB Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Advanced pancreatic cancer, Metastatic pancreatic cancer, Gemcitabine, Chemo-naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
  2. Chemo naïve patients with advanced/metastatic disease
  3. Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee.
  4. Men and women, age >18 years
  5. Men and women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test), must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
  6. Patient should be able and willing to comply with study visits and procedures as per protocol.
  7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.

Main Exclusion Criteria:

  1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrollment, with the exception of basal cell carcinoma or in situ cervical cancer
  2. Any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment
  3. Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline
  4. Treatment with any investigational agent within 4 weeks prior to baseline

Sites / Locations

  • Eastern Connecticut Hematology and Oncology (ECHO)
  • MD Anderson
  • The Emory Clinic
  • Decatur Memorial Hospital
  • Medical & Surgical Specialists
  • Berkshire Hematology Oncology
  • Henry Ford Health System
  • Metro MN CCOP
  • Saint Luke's Cancer Institute
  • The Valley Hospital
  • Southeastern Medical Oncology Center
  • Oregon Health & Science University
  • Teaching Hospital Brno-Bohunice
  • Hospital Chomutov
  • Oncology Surgery
  • Department of Oncology Teaching Hospital Olomouc
  • Teaching Hospital Královské
  • Teaching Hospital Na Bulovce
  • Hospital na Homolce
  • CHU Amiens
  • Hôpital Privé d'Antony
  • Institut Sainte-Catherine
  • Hôpital Jean Minjoz
  • Hôpital Saint-André
  • CHU de la Cavale Blanche
  • CHU de Caen
  • CHU Hôtel Dieu
  • Groupement Hospitalier Universitaire Nord - Beaujon
  • CHU Henri Mondor
  • CHU Henri Mondor
  • Hôpital Victor Jousselin
  • Centre Gastro-Loire
  • Institut Daniel Hollard
  • CHD Les Oudairies
  • Hôpital André Mignot
  • Hôpital Robert Boulin
  • Hôpital Claude Huriez
  • Centre Hospitalier de Longjumeau
  • Hôpital Privé Jean Mermoz
  • Hôpital Edouard Herriot
  • Centre Léon Bérard
  • Assistance Publique des Hôpitaux de Marseille
  • Hôpital Saint Joseph
  • Centre Hospitalier Belfort - Montbéliard
  • CHU Hôtel Dieu
  • Centre Catherine de Sienne
  • Hôpital de la Source
  • Groupe Hospitalier Diaconesse Croix Saint Simon
  • Hôpital Tenon
  • Hôpital Hôtel Dieu
  • Hôpital Saint-Joseph
  • Polyclinique Francheville
  • Hôpital Haut-Lévêque
  • Hôpital Hautepierre
  • CHU Brabois
  • Hôpital Paul Brousse
  • Hotel Dieu de France
  • Makassed General Hospital Tarik Jadide
  • Rafik Hariri University Hospital
  • Saint Georges Hospital UMC
  • Middle East Institute of Health- Bsaleem
  • Saint Joseph Hospital Baouchrieh
  • Hammoud Hospital University Medical Center
  • Municipal Clinical Hospital
  • County Hospital
  • Emergency Clinical Hospital
  • Pelica Impex SRL Hospital
  • County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Masitinib & gemcitabine

Placebo & gemcitabine

Arm Description

Participants receive masitinib (9 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 (OS)
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 rate
Defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution.
Progression Free Survival (PFS)
Progression Free Survival 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

First Posted
November 12, 2008
Last Updated
December 13, 2018
Sponsor
AB Science
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1. Study Identification

Unique Protocol Identification Number
NCT00789633
Brief Title
Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
Official Title
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 25, 2008 (Actual)
Primary Completion Date
December 23, 2011 (Actual)
Study Completion Date
August 31, 2012 (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
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.
Detailed Description
Human pancreatic cancer overexpresses a number of important tyrosine kinase (TK) growth factors receptors and ligands, including expression of both PDGF and PDGF receptors. Drugs that can selectively inhibit TKs are likely to be of benefit in pancreatic cancer. Masitinib is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases. Pre-clinical and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor cell lines to gemcitabine. Based on pre-clinical and phase 2 clinical studies, masitinib can be considered as a good candidate to use in combination with gemcitabine in the treatment of pancreatic cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Advanced pancreatic cancer, Metastatic pancreatic cancer, Gemcitabine, Chemo-naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Masitinib & gemcitabine
Arm Type
Experimental
Arm Description
Participants receive masitinib (9 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
Placebo 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 Description
Masitinib at 9 mg/kg/day given orally twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo given orally twice daily
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine at 1000 mg/m2 by intravenous infusion
Primary Outcome Measure Information:
Title
Overall Survival (OS)
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 the date of death, assessed up to 60 months
Secondary Outcome Measure Information:
Title
Survival rate
Description
Defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution.
Time Frame
Every 24 weeks, assessed up to 60 months
Title
Progression Free Survival (PFS)
Description
Progression Free Survival 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, whichever came first, assessed up to 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 Chemo naïve patients with advanced/metastatic disease Documented decision justifying non eligibility for surgical resection. The documentation of the non eligibility for surgical resection will be reviewed by an independent committee. Men and women, age >18 years Men and women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test), must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. Patient should be able and willing to comply with study visits and procedures as per protocol. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Main Exclusion Criteria: Patient treated for a cancer other than pancreatic cancer within 5 years before enrollment, with the exception of basal cell carcinoma or in situ cervical cancer Any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment Any anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy) within 6 months prior to baseline Treatment with any investigational agent within 4 weeks prior to baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaël Deplanque, MD
Organizational Affiliation
Hôpital Saint Joseph, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Connecticut Hematology and Oncology (ECHO)
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
MD Anderson
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Medical & Surgical Specialists
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Berkshire Hematology Oncology
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Metro MN CCOP
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Saint Luke's Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Teaching Hospital Brno-Bohunice
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Hospital Chomutov
City
Chomutov
ZIP/Postal Code
430 12
Country
Czechia
Facility Name
Oncology Surgery
City
Kutná Hora
ZIP/Postal Code
284 30
Country
Czechia
Facility Name
Department of Oncology Teaching Hospital Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Teaching Hospital Královské
City
Prague 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Teaching Hospital Na Bulovce
City
Prague 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Hospital na Homolce
City
Prague
ZIP/Postal Code
5 150 30
Country
Czechia
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
Hôpital Privé d'Antony
City
Antony
ZIP/Postal Code
92160
Country
France
Facility Name
Institut Sainte-Catherine
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Hôpital Jean Minjoz
City
Besançon
Country
France
Facility Name
Hôpital Saint-André
City
Bordeaux
Country
France
Facility Name
CHU de la Cavale Blanche
City
Brest
ZIP/Postal Code
29600
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Hôtel Dieu
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Groupement Hospitalier Universitaire Nord - Beaujon
City
Clichy
ZIP/Postal Code
92
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
Country
France
Facility Name
Hôpital Victor Jousselin
City
Dreux
Country
France
Facility Name
Centre Gastro-Loire
City
Gien
ZIP/Postal Code
45500
Country
France
Facility Name
Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
CHD Les Oudairies
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Hôpital André Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Hôpital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Hospitalier de Longjumeau
City
Longjumeau
ZIP/Postal Code
91164
Country
France
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Assistance Publique des Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Hôpital Saint Joseph
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Centre Hospitalier Belfort - Montbéliard
City
Montbeliard
ZIP/Postal Code
25200
Country
France
Facility Name
CHU Hôtel Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44200
Country
France
Facility Name
Hôpital de la Source
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
Groupe Hospitalier Diaconesse Croix Saint Simon
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital Hôtel Dieu
City
Paris
Country
France
Facility Name
Hôpital Saint-Joseph
City
Paris
Country
France
Facility Name
Polyclinique Francheville
City
Perigueux
ZIP/Postal Code
24000
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
CHU Brabois
City
Vandoeuvre lès Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Hôpital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Hotel Dieu de France
City
Beirut
Country
Lebanon
Facility Name
Makassed General Hospital Tarik Jadide
City
Beirut
Country
Lebanon
Facility Name
Rafik Hariri University Hospital
City
Beirut
Country
Lebanon
Facility Name
Saint Georges Hospital UMC
City
Beirut
Country
Lebanon
Facility Name
Middle East Institute of Health- Bsaleem
City
Metn
Country
Lebanon
Facility Name
Saint Joseph Hospital Baouchrieh
City
Metn
Country
Lebanon
Facility Name
Hammoud Hospital University Medical Center
City
Saida
Country
Lebanon
Facility Name
Municipal Clinical Hospital
City
Arad
ZIP/Postal Code
310013
Country
Romania
Facility Name
County Hospital
City
Baia-Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Emergency Clinical Hospital
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Pelica Impex SRL Hospital
City
Pelica Impex
ZIP/Postal Code
410548
Country
Romania
Facility Name
County Hospital
City
Satu Mare
ZIP/Postal Code
440056
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
25858497
Citation
Deplanque G, Demarchi M, Hebbar M, Flynn P, Melichar B, Atkins J, Nowara E, Moye L, Piquemal D, Ritter D, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Hammel P. A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer. Ann Oncol. 2015 Jun;26(6):1194-1200. doi: 10.1093/annonc/mdv133. Epub 2015 Apr 9.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4516046/
Description
Link to article

Learn more about this trial

Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

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