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

History of Changes

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:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

Genetic and Rare Diseases Information Center resources: Gastrointestinal Stromal Tumors

U.S. FDA Resources

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically proven, metastatic or locally advanced non resectable, or recurrent post surgery GIST
Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
C-Kit (CD117) positive tumours detected immuno-histochemically or PDGF positive if c-kit negative
Man or woman, age >18 years
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
Patient able and willing to comply with study procedures as per protocol
Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures

Exclusion Criteria:

Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 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
Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
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
Treatment with any investigational agent within 4 weeks prior baseline
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

Show 43 Study Locations

Sponsors and Collaborators

AB Science

Investigators


Principal Investigator:	Antoine Adenis, MD	Centre Oscar Lambret, Lille, France

More Information


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, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms	Digestive System Diseases Gastrointestinal Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016

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