A Phase 2 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01506336
Recruitment Status : Unknown
Verified September 2012 by AB Science.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2012
Last Update Posted : September 26, 2012
Information provided by (Responsible Party):
AB Science

Brief Summary:
The objective is 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.

Condition or disease Intervention/treatment Phase
Gastro Intestinal Stromal Tumor Drug: masitinib Drug: sunitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : September 2011
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: masitinib
masitinib 12 mg/kg/day
Drug: masitinib
masitinib 12 mg/kg/day

Active Comparator: sunitinib
sunitinib 50 mg/day
Drug: sunitinib
sunitinib 50 mg/day

Primary Outcome Measures :
  1. overall progression free survival [ Time Frame: up to 36 weeks ]
    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

Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to 36 weeks ]
    From date of randomization until the date of death from any cause, assessed up to 36 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01506336

Institute Gustave Roussy (IGR)
Villejuif, France, 94815
Sponsors and Collaborators
AB Science

Responsible Party: AB Science Identifier: NCT01506336     History of Changes
Other Study ID Numbers: AB07001
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Keywords provided by AB Science:
gastro intestinal stromal tumor resistant to imatinib

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors