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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 : Completed
First Posted : September 27, 2012
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
AB Science

Tracking Information
First Submitted Date  ICMJE August 22, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date December 8, 2020
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
Overall Survival (OS) [ Time Frame: up to 24 weeks ]
Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • Time to Progression [ Time Frame: up to 24 weeks ]
    Time to Progression from the date of randomization until disease progression
  • Overall Progression Free Survival (PFS) [ Time Frame: up to 24 weeks ]
    From the date of randomization to disease progression or death
  • Survival rate [ Time Frame: up to 24 weeks ]
    from the date of randomization until death
  • Objective Response Rate [ Time Frame: up to 24 weeks ]
    Partial response or total Response
  • Control Disease Rate [ Time Frame: up to 24 weeks ]
    Disease Control documented partial response (PR), complete response (CR) or stable disease (SD
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
Official Title  ICMJE 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
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumors
Intervention  ICMJE
  • Drug: Masitinib
    12 mg/kg/day
    Other Name: AB1010
  • Drug: Sunitinib
    50 mg/day
    Other Name: Sutent
Study Arms  ICMJE
  • Experimental: Masitinib
    Participants receive masitinib (12 mg/kg/day), given orally twice daily.
    Intervention: Drug: Masitinib
  • Active Comparator: Sunitinib
    Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
    Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2019)
258
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2012)
208
Actual Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694277
Other Study ID Numbers  ICMJE AB11002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AB Science
Study Sponsor  ICMJE AB Science
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Axel Le Cesne, M.D., Ph.D Institute Gustave Roussy
PRS Account AB Science
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP