Gastrointestinal Stromal TumorsPhase 3NCT00812240
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
A Phase 3 study testing Masitinib and Imatinib in people with Gastrointestinal Stromal Tumors, run by AB Science at 41 sites in 3 countries.
Trial summary
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Masitinib and Imatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 41 sitesin 3 countries
- Study dates
- Jan 2009to Jul 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
France29 sites
Centre Hospitalier d'Abbeville
Abbeville, 80142
Institut Sainte Catherine
Avignon, 84000
Hôpital Jean Minjoz
Besançon, 25000
Institut Bergonié
Bordeaux, 33000
Hôpital Morvan
Brest, 29200
Hôpitalo Henri Mondor
Créteil, 94000
Centre Georges François Leclerc
Dijon, 21000
Hopital Bocage
Dijon, 21079
Centre Hospitalier Victor Jousselin
Dreux, 28100
Clinique Pasteur
Évreux, 27000
Centre Hospitalier de Gap
Gap, 05000
CHD de Vendée
La Roche-sur-Yon, 85925
Centre Hsopitalier de La Rochelle
La Rochelle, 17000
Centre Hospitalier Robert Boulin
Libourne, 33500
Centre Oscar Lambret
Lille, 59000
Centre Léon Bérard
Lyon, 69000
Institut Paoli Calmette
Marseille, 13200
Centre Val d'Aurèle
Montpellier, 34000
Centre René Gauducheau
Nantes, 44800
Hôpital de la Source
Orléans, 45000
Groupe Hospitalier Diaconesse Croix Saint Simon
Paris, 75012
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Bichat Claude Bernard
Paris, 75018
Hôpital Tenon
Paris, 75020
Hôpital Robert Debré
Reims, 51000
Hôpital Charles Nicolle
Rouen, 76000
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22000
Centre René Huguenin
Saint-Cloud, 92210
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270
United States7 sites
The Emory Clinic
Atlanta, Georgia, 30322
Ohio State University
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
Cancer Centers of the Carolinas
Greenville, South Carolina, 290605
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Beth Israel Medical Center
New York, New York, 10003
MD Anderson Cancer Center
Orlando, Florida, 32806
Lebanon5 sites
Hotel Dieu de France
Beirut
Hôpital Saint-Georges
Beirut
Makassed General Hospital Tarik Jadide
Beirut
Rafik Hariri University Hospital
Beirut
Hôpital Saint-Joseph
Jdeïdé
About this study
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
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Read the 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.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Masitinib, Imatinib
- Keywords
- Gastro-Intestinal Stromal Tumor, GIST, metastatic, non resectable locally advanced
- Medical subject headings
- Gastrointestinal Stromal Tumors, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MasitinibDrug
Also called AB1010
ImatinibDrug
Also called Gleevec
imatinib 400 mg or 600 mg per day, per os
| Study group | Role | What they receive |
|---|---|---|
| Masitinib (7.5) | Experimental | Participants receive masitinib (7.5 mg/kg/day), given orally twice daily. Receives: Drug: Masitinib |
| Masitinib (6.0) | Experimental | Participants receive masitinib (6.0 mg/kg/day), given orally twice daily Receives: Drug: Masitinib |
| Active Comparator (7.5) | Active comparator | Participants receive imatinib at 400 or 600 mg per day Receives: Drug: Imatinib |
| Active Comparator (6.0) | Active comparator | Participants receive imatinib at 400 or 600 mg per day Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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).
Measured: From day of randomization to disease progression or death, assessed for a maximum of 96 months]
Secondary outcomes (1)
Overall Survival (OS)
Overall survival is defined as time in months from the randomization date to the date of death due to any cause
Measured: From day of randomization to death, assessed for a maximum of 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Sponsor decision based on portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antoine Adenis, MD, Principal investigator, Centre Oscar Lambret, Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812240
- Sponsor's protocol ID
- AB04030
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2008
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00812240
- Acronym / sponsor ID
- AB04030
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastro-Intestinal Stromal Tumor, GIST, metastatic, non resectable locally advanced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on portfolio prioritization
- Enrolment
- 335 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Jan 2009 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Masitinib (7.5) | Experimental | Drug: MasitinibParticipants receive masitinib (7.5 mg/kg/day), given orally twice daily. |
| Masitinib (6.0) | Experimental | Drug: MasitinibParticipants receive masitinib (6.0 mg/kg/day), given orally twice daily |
| Active Comparator (7.5) | Active comparator | Drug: ImatinibParticipants receive imatinib at 400 or 600 mg per day |
| Active Comparator (6.0) | Active comparator | Drug: ImatinibParticipants receive imatinib at 400 or 600 mg per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MasitinibAlso: AB1010 | Drug | Masitinib (6.0), Masitinib (7.5) |
| ImatinibAlso: Gleevecimatinib 400 mg or 600 mg per day, per os | Drug | Active Comparator (6.0), Active Comparator (7.5) |
Primary outcome
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).
1 secondary outcome
Overall Survival (OS)
Time frame: From day of randomization to death, assessed for a maximum of 96 months
Results and safety
The study was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Adenis, MD principal investigator
Centre Oscar Lambret, Lille, France
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Masitinib and Imatinib in people with Gastrointestinal Stromal Tumors, run by AB Science at 41 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in France, United States, Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision based on portfolio prioritization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From day of randomization to disease progression or death, assessed for a maximum of 96 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.