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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 Tumour in First Line Medical Treatment


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumors

Thank you

Trial Information

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 Tumour in First Line Medical Treatment


GISTs are uncommon visceral sarcomas that arise predominantly in the gastro-intestinal
tract. Most GIST cells are positive for c-kit (CD117), a cell surface antigen corresponding
to the Stem Cell Factor (SCF) receptor. The receptor has an intracellular tyrosine kinase
(TK) joined by a juxtamembrane domain. It is hypothesized that all malignant GIST cells
harbor a mutation of c-kit, resulting in the activation of c-kit and cell division and
tumour growth. Drugs that can selectively inhibit TKs are likely to be of benefit in GISTs.
Masitinib (AB1010) is a TK inhibitor, selectively and effectively inhibiting c-kit. Imatinib
is also a TK inhibitor indicated in the treatment of GIST. It might be associated with side
effects and patients might develop a resistance to treatment over time. Based on
pre-clinical and clinical studies, masitinib (AB1010) can be considered as a good candidate
in the first line treatment of patients with GIST.


Inclusion Criteria:



1. Histologically proven, metastatic or locally advanced non resectable, or recurrent
post surgery GIST

2. Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who
relapsed after imatinib discontinuation

3. C-Kit (CD117) positive tumours detected immuno-histochemically or PDGF positive if
c-kit negative

4. Man or woman, age >18 years

5. Man and woman of childbearing potential, (entering the study after a menstrual period
and who have a negative pregnancy test) must agree to use two methods (one for the
patient and one for the partner) of medically acceptable forms of contraception
during the study and for 3 months after the last treatment intake

6. Patient able and willing to comply with study procedures as per protocol

7. Patient able to understand, sign, and date the written voluntary informed consent
form at screening visit prior to any protocol-specific procedures

Exclusion Criteria:

1. Patient previously treated by tyrosine kinase inhibitors except imatinib in case of
inclusion criteria 2

2. 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

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

4. Patient with grade III/IV cardiac problems as defined by the New York Heart
Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6
months before baseline) Patient with any condition that the physician judges could be
detrimental to subjects participating in this study; including any clinically
important deviations from normal clinical laboratory values or concurrent medical
events Previous treatment

5. Treatment with any investigational agent within 4 weeks prior baseline

6. Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Antoine Adenis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret, Lille, France

Authority:

United States: Food and Drug Administration

Study ID:

AB04030

NCT ID:

NCT00812240

Start Date:

January 2009

Completion Date:

December 2013

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Gastro-Intestinal Stromal Tumour
  • GIST
  • non resectable
  • recurrent post-surgery
  • first line of treatment
  • metastatic
  • locally advanced
  • Gastrointestinal Stromal Tumors

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226
Beth Israel Medical CenterNew York, New York  10003
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Henry Ford Health SystemDetroit, Michigan  48202
Ohio State UniversityColumbus, Ohio  43210
The Emory ClinicAtlanta, Georgia  30322
MD Anderson Cancer CenterOrlando, Florida  32806