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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT01506336
First received: January 3, 2012
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Gastro Intestinal Stromal Tumor
 Drug: masitinib
Drug: sunitinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by AB Science:

Primary Outcome Measures:
  • overall progression free survival [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
    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:
  • overall survival [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
    From date of randomization until the date of death from any cause, assessed up to 36 weeks


Enrollment: 44
Study Start Date: October 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506336

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

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01506336     History of Changes
Other Study ID Numbers: AB07001
Study First Received: January 3, 2012
Last Updated: September 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Sunitinib
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013