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Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

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ClinicalTrials.gov Identifier: NCT01694277
Recruitment Status : Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief Summary:
The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: Masitinib Drug: Sunitinib 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. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant gastro-intestinal stromal tumor (GIST).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment
Study Start Date : April 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Masitinib
Participants receive masitinib (12 mg/kg/day), given orally twice daily.
Drug: Masitinib
12 mg/kg/day
Other Name: AB1010

Active Comparator: Sunitinib
Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
Drug: Sunitinib
50 mg/day
Other Name: Sutent




Primary Outcome Measures :
  1. Overall Survival (OS) [ 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 rate [ Time Frame: Every 12 weeks until study completion, assessed for a maximum of 60 months ]
    Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.

  2. Progression Free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months ]
    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 and/or CHOI 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 include:

  • Patient with histological proven metastatic GIST or non-operable locally advanced GIST
  • Patient with c-Kit (CD117) positive tumor detected immuno-histochemically
  • Patient after at least one progression with imatinib at a dose up to 800mg. Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving imatinib treatment.

Main exclusion criteria include:

  • 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
  • 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): NCT01694277


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
France
Institut Bergonié
Bordeaux, France, 33000
Hôpital l'Archet 2- Service de Cancérologie Digestive
Nice, France, 06202
Italy
Istituto per la Ricerca e la Cura del Cancro (IRCC)
Candiolo, Italy, 10060
Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands, 3015 GD
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Axel Le Cesne, M.D., Ph.D Institute Gustave Roussy

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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01694277     History of Changes
Other Study ID Numbers: AB11002
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Keywords provided by AB Science:
Gastrointestinal Stromal Tumour
GIST
non-resectable
metastatic
second line treatment
resistance to imatinib
tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Sunitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors