Clinical Trials /

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

NCT01694277

Description:

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.

Related Conditions:
  • Gastrointestinal Stromal Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
  • 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

Clinical Trial IDs

  • ORG STUDY ID: AB11002
  • NCT ID: NCT01694277

Conditions

  • Gastrointestinal Stromal Tumors

Interventions

DrugSynonymsArms
MasitinibAB1010Masitinib
SunitinibSutentSunitinib

Purpose

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).
    

Trial Arms

NameTypeDescriptionInterventions
MasitinibExperimentalParticipants receive masitinib (12 mg/kg/day), given orally twice daily.
  • Masitinib
SunitinibActive ComparatorParticipants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
  • Sunitinib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:From day of randomization to death, assessed for a maximum of 60 months
Safety Issue:
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.

Secondary Outcome Measures

Measure:Survival rate
Time Frame:Every 12 weeks until study completion, assessed for a maximum of 60 months
Safety Issue:
Description: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.
Measure:Progression Free Survival (PFS)
Time Frame:From day of randomization to disease progression or death, assessed for a maximum of 60 months
Safety Issue:
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 and/or CHOI criteria.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AB Science

Trial Keywords

  • Gastrointestinal Stromal Tumour
  • GIST
  • non-resectable
  • metastatic
  • second line treatment
  • resistance to imatinib
  • tyrosine kinase inhibitor

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