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Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Sponsor
AB Science (Industry)
Overall Status
Terminated
CT.gov ID
NCT00812240
Collaborator
(none)
335
Enrollment
43
Locations
4
Arms
113.9
Actual Duration (Months)
7.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

Study Design

Study Type:
Interventional
Actual Enrollment :
335 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment
Actual Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Masitinib (7.5)

Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.

Drug: Masitinib
Other Names:
  • AB1010

    		•
    Experimental: Masitinib (6.0)

    Participants receive masitinib (6.0 mg/kg/day), given orally twice daily

    Drug: Masitinib
    Other Names:
  • AB1010

    		•
    Active Comparator: Active Comparator (7.5)

    Participants receive imatinib at 400 or 600 mg per day

    Drug: Imatinib
    imatinib 400 mg or 600 mg per day, per os
    Other Names:
  • Gleevec

    		•
    Active Comparator: Active Comparator (6.0)

    Participants receive imatinib at 400 or 600 mg per day

    Drug: Imatinib
    imatinib 400 mg or 600 mg per day, per os
    Other Names:
  • Gleevec

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [From day of randomization to disease progression or death, assessed for a maximum of 96 months]]

      Progression Free Survival is defined as the time from randomization to first documentation of objective tumor progression (date of tumor assessment documenting progressive disease assessed by CT Scan according to RECIST 1.1 and based on central review) or to death due to any cause (whichever comes first).

    Secondary Outcome Measures

    1. Overall Survival (OS) [From day of randomization to death, assessed for a maximum of 96 months]

      Overall survival is defined as time in months from the randomization date to the date of death due to any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Main inclusion criteria include:

    • Histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery GIST

    • Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation

    • c-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-Kit negative

    Main exclusion criteria include:

    • Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria

    • Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ

    • Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD Anderson Cancer Center Orlando Florida United States 32806
    2 The Emory Clinic Atlanta Georgia United States 30322
    3 Henry Ford Health System Detroit Michigan United States 48202
    4 Beth Israel Medical Center New York New York United States 10003
    5 Ohio State University Columbus Ohio United States 43210
    6 Cancer Centers of the Carolinas Greenville South Carolina United States 290605
    7 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    8 Centre Hospitalier d'Abbeville Abbeville France 80142
    9 Institut Sainte Catherine Avignon France 84000
    10 Hôpital Jean Minjoz Besançon France 25000
    11 Institut Bergonié Bordeaux France 33000
    12 Hôpital Morvan Brest France 29200
    13 Hôpitalo Henri Mondor Créteil France 94000
    14 Centre Georges François Leclerc Dijon France 21000
    15 Hopital Bocage Dijon France 21079
    16 Centre Hospitalier Victor Jousselin Dreux France 28100
    17 Clinique Pasteur Evreux France 27000
    18 Centre Hospitalier de Gap Gap France 05000
    19 CHD de Vendée La Roche sur Yon France 85925
    20 Centre Hsopitalier de La Rochelle La Rochelle France 17000
    21 Centre Hospitalier Robert Boulin Libourne France 33500
    22 Centre Oscar Lambret Lille France 59000
    23 Centre Léon Bérard Lyon France 69000
    24 Institut Paoli Calmette Marseille France 13200
    25 Centre Val d'Aurèle Montpellier France 34000
    26 Centre René Gauducheau Nantes France 44800
    27 Hôpital de la Source Orléans France 45000
    28 Groupe Hospitalier Diaconesse Croix Saint Simon Paris France 75012
    29 Hôpital Européen Georges Pompidou Paris France 75015
    30 Hôpital Bichat Claude Bernard Paris France 75018
    31 Hôpital Tenon Paris France 75020
    32 Hôpital Robert Debré Reims France 51000
    33 Hôpital Charles Nicolle Rouen France 76000
    34 Clinique Armoricaine de Radiologie Saint Brieuc France 22000
    35 Institut de Cancérologie de la Loire Saint Priez-en-Jarez France 42270
    36 Centre René Huguenin Saint-Cloud France 92210
    37 Hotel Dieu de France Beirut Lebanon
    38 Hôpital Saint-Georges Beirut Lebanon
    39 Makassed General Hospital Tarik Jadide Beirut Lebanon
    40 Rafik Hariri University Hospital Beirut Lebanon
    41 Hôpital Saint-Joseph Metn Lebanon
    42 Middle East Institute of Health- Bsaleem Metn Lebanon
    43 Hammoud Hospital University Medical Center Saida Lebanon

    Sponsors and Collaborators

    • AB Science

    Investigators

    • Principal Investigator: Antoine Adenis, MD, Centre Oscar Lambret, Lille, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AB Science
    ClinicalTrials.gov Identifier:
    NCT00812240
    Other Study ID Numbers:
    • AB04030
    First Posted:
    Dec 22, 2008
    Last Update Posted:
    Dec 4, 2019
    Last Verified:
    Dec 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AB Science
    Gastro-Intestinal Stromal Tumor
    GIST
    metastatic
    non resectable locally advanced
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors
    Imatinib Mesylate

    Study Results

    No Results Posted as of Dec 4, 2019