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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by AB Science.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Florida
MD Anderson Cancer Center Recruiting
Orlando, Florida, United States, 32806
United States, Georgia
The Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact    866-627-7616    osu@emergingmed.com   
United States, South Carolina
Cancer Centers of the Carolinas Recruiting
Greenville, South Carolina, United States, 290605
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
France
Centre Hospitalier d'Abbeville Recruiting
Abbeville, France, 80142
Institut Sainte Catherine Recruiting
Avignon, France, 84000
Hôpital Jean Minjoz Recruiting
Besançon, France, 25000
Institut Bergonié Recruiting
Bordeaux, France, 33000
Hôpital Morvan Recruiting
Brest, France, 29200
Hôpitalo Henri Mondor Recruiting
Créteil, France, 94000
Centre Georges François Leclerc Recruiting
Dijon, France, 21000
Hopital Bocage Recruiting
Dijon, France, 21079
Centre Hospitalier Victor Jousselin Recruiting
Dreux, France, 28100
Clinique Pasteur Recruiting
Evreux, France, 27000
Centre Hospitalier de Gap Recruiting
Gap, France, 05000
CHD de Vendée Recruiting
La Roche sur Yon, France, 85925
Centre Hsopitalier de La Rochelle Recruiting
La Rochelle, France, 17000
Centre Hospitalier Robert Boulin Recruiting
Libourne, France, 33500
Centre Oscar Lambret Recruiting
Lille, France, 59000
Centre Léon Bérard Recruiting
Lyon, France, 69000
Institut Paoli Calmette Recruiting
Marseille, France, 13200
Centre Val d'Aurèle Recruiting
Montpellier, France, 34000
Centre René Gauducheau Recruiting
Nantes, France, 44800
Hôpital de la Source Recruiting
Orléans, France, 45000
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Hôpital Bichat Claude Bernard Recruiting
Paris, France, 75018
Hôpital Tenon Recruiting
Paris, France, 75020
Groupe Hospitalier Diaconesse Croix Saint Simon Recruiting
Paris, France, 75012
Hôpital Robert Debré Recruiting
Reims, France, 51000
Hôpital Charles Nicolle Recruiting
Rouen, France, 76000
Clinique Armoricaine de Radiologie Recruiting
Saint Brieuc, France, 22000
Centre René Huguenin Recruiting
Saint-Cloud, France, 92210
Institut de Cancérologie de la Loire Not yet recruiting
St Priez-en-Jarez, France, 42270
Lebanon
Makassed General Hospital Tarik Jadide Recruiting
Beirut, Lebanon
Hôpital Saint-Georges Recruiting
Beirut, Lebanon
Hotel Dieu de France Recruiting
Beirut, Lebanon
Rafik Hariri University Hospital Recruiting
Beirut, Lebanon
Hôpital Saint-Joseph Recruiting
Metn, Lebanon
Middle East Institute of Health- Bsaleem Recruiting
Metn, Lebanon
Hammoud Hospital University Medical Center Recruiting
Saida, Lebanon
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
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014