Clinical Trials /

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

NCT00812240

Description:

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

Related Conditions:
  • Gastrointestinal Stromal Tumor
Recruiting Status:

Terminated

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT00812240

Trial Eligibility

Document

Title

  • Brief Title: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: AB04030
  • NCT ID: NCT00812240

Conditions

  • Gastrointestinal Stromal Tumors

Interventions

DrugSynonymsArms
MasitinibAB1010Masitinib (6.0)
ImatinibGleevecActive Comparator (6.0)

Purpose

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

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.

Trial Arms

NameTypeDescriptionInterventions
Masitinib (7.5)ExperimentalParticipants receive masitinib (7.5 mg/kg/day), given orally twice daily.
  • Masitinib
Masitinib (6.0)ExperimentalParticipants receive masitinib (6.0 mg/kg/day), given orally twice daily
  • Masitinib
Active Comparator (7.5)Active ComparatorParticipants receive imatinib at 400 or 600 mg per day
  • Imatinib
Active Comparator (6.0)Active ComparatorParticipants receive imatinib at 400 or 600 mg per day
  • Imatinib

Eligibility Criteria

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

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:From day of randomization to disease progression or death, assessed for a maximum of 96 months]
Safety Issue:
Description: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

Measure:Overall Survival (OS)
Time Frame:From day of randomization to death, assessed for a maximum of 96 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

Details

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

Trial Keywords

  • Gastro-Intestinal Stromal Tumor
  • GIST
  • metastatic
  • non resectable locally advanced

Last Updated

December 4, 2019