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Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00812240
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : December 22, 2008
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief Summary:
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: Masitinib Drug: Imatinib Phase 3

Detailed Description:
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit, the juxta membrane domain of c-Kit, and PDGFR. In addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (GIST). Treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Tumor in First Line Medical Treatment
Actual Study Start Date : January 2009
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Masitinib (7.5)
Participants receive masitinib (7.5 mg/kg/day), given orally twice daily.
Drug: Masitinib
Masitinib st 6.0 or 7.5 mg/kg/day, per os
Other Name: AB1010

Experimental: Masitinib (6.0)
Participants receive masitinib (6.0 mg/kg/day), given orally twice daily
Drug: Masitinib
Masitinib st 6.0 or 7.5 mg/kg/day, per os
Other Name: AB1010

Active Comparator: Active Comparator (7.5)
Participants receive imatinib at 400 or 600 mg per day
Drug: Imatinib
imatinib 400 mg or 600 mg per day, per os
Other Name: Gleevec

Active Comparator: Active Comparator (6.0)
Participants receive imatinib at 400 or 600 mg per day
Drug: Imatinib
imatinib 400 mg or 600 mg per day, per os
Other Name: Gleevec




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death, assessed for a maximum of 96 months] ]
    Progression Free Survival is defined as the time from randomization to first documentation of objective tumor progression (date of tumor assessment documenting progressive disease assessed by CT Scan according to RECIST 1.1 and based on central review) or to death due to any cause (whichever comes first).


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From day of randomization to death, assessed for a maximum of 96 months ]
    Overall survival is defined as time in months from the randomization date to the date of death due to any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main inclusion criteria include:

  • 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 by immuno-histochemically or PDGFR positive if c-Kit negative

Main exclusion criteria include:

  • Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812240


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

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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT00812240     History of Changes
Other Study ID Numbers: AB04030
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AB Science:
Gastro-Intestinal Stromal Tumor
GIST
metastatic
non resectable locally advanced

Additional relevant MeSH terms:
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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