A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Imatinib in Patients With Gastro-Intestinal Stromal Tumour in First Line Medical Treatment

This study is currently recruiting participants.
Verified September 2012 by AB Science
Sponsor:
Information provided by (Responsible Party):
AB Science
ClinicalTrials.gov Identifier:
NCT00812240
First received: December 19, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

The objective of the study is to compare the efficacy and safety of masitinib to imatinib in patients with gastro-intestinal stromal tumour (GIST) in first line medical treatment.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: masitinib (AB1010)
Drug: imatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 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

Resource links provided by NLM:


Further study details as provided by AB Science:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 222
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
masitinib 7.5 mg/kg/day, per os
Drug: masitinib (AB1010)
masitinib (AB1010) 7.5 mg/kg/day, per os
Other Name: AB1010
Active Comparator: 2
imatinib 400 mg or 600 mg per day, per os
Drug: imatinib
imatinib 400 mg or 600 mg per day, per os

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812240

Contacts
Contact: Antoine Adenis, M.D. +33 (0)3 20 29 59 59 a-adenis@o-lambret.fr

  Show 43 Study Locations
Sponsors and Collaborators
AB Science
Investigators
Principal Investigator: Antoine Adenis, MD Centre Oscar Lambret, Lille, France
  More Information

No publications provided

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00812240     History of Changes
Other Study ID Numbers: AB04030
Study First Received: December 19, 2008
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration
France: Direction Générale de la Santé
Lebanon: Ministry of Public Health

Keywords provided by AB Science:
Gastro-Intestinal Stromal Tumour
GIST
non resectable
recurrent post-surgery
first line of treatment
metastatic
locally advanced

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014