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A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastro Intestinal Stromal Tumor

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Trial Information

A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib


Inclusion Criteria:



1. Histological proven, metastatic, or locally advanced and non-operable GIST

2. Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques
or ≥ 10 mm with spiral CT scan according RECIST criteria

3. C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation
of c-kit at any time if available

4. Patients resistant to imatinib at dose of 400 mg/day

Exclusion Criteria:

1. Patient treated for a cancer other than GIST cancer within 5 years before enrolment,
with the exception of basal cell carcinoma or cervical cancer in situ

2. Patient with active central nervous system (CNS) metastasis or with history of CNS
metastasis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall progression free survival

Outcome Description:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks

Outcome Time Frame:

up to 36 weeks

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AB07001

NCT ID:

NCT01506336

Start Date:

October 2008

Completion Date:

December 2013

Related Keywords:

  • Gastro Intestinal Stromal Tumor
  • GIST
  • resistant
  • imatinib
  • gastro intestinal stromal tumor resistant to imatinib
  • Gastrointestinal Stromal Tumors

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