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Completed

NCT Number: NCT01694277

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

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.

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Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Bergonié, Bordeaux, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masitinib

Drug

12 mg/kg/day

Other names: AB1010

Sunitinib

Drug

50 mg/day

Other names: Sutent

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2012
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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