Gastro Intestinal Stromal TumorPhase 2NCT01506336
Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib
A Phase 2 study testing masitinib and sunitinib in people with Gastro Intestinal Stromal Tumor, run by AB Science at 1 site in France.
Trial summary
The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Intestinal Stromal Tumor
- What is being tested?
- masitinib and sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Apr 2012
- Phase
- Phase 2
- 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
Who may be able to join
- Histological proven, metastatic, or locally advanced and non-operable GIST
- Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
- C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
- Patients resistant to imatinib at dose of 400 mg/day
Who cannot join
- Patient treated for a cancer other than GIST cancer 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
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib
The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.
- Conditions
- Gastro Intestinal Stromal Tumor
- Being tested
- masitinib, sunitinib
- Keywords
- GIST, resistant, imatinib, gastro intestinal stromal tumor resistant to imatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
masitinibDrug
masitinib 12 mg/kg/day
sunitinibDrug
sunitinib 50 mg/day
| Study group | Role | What they receive |
|---|---|---|
| masitinib | Experimental | masitinib 12 mg/kg/day Receives: Drug: masitinib |
| sunitinib | Active comparator | sunitinib 50 mg/day Receives: Drug: sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall progression free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
Measured: up to 36 weeks
Secondary outcomes (1)
overall survival
From date of randomization until the date of death from any cause, assessed up to 36 weeks
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro Intestinal Stromal TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Le Cesne, MD, Principal investigator, Institut Gustave Roussy, Villejuif, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506336
- Sponsor's protocol ID
- AB07001
- Status last verified
- Dec 2018
- First submitted
- 3 Jan 2012
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adenis A, Blay JY, Bui-Nguyen B, Bouche O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blesius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-1769. doi: 10.1093/annonc/mdu237. Epub 2014 Jul 25.
PubMed 25122671
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. 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 II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib
- ClinicalTrials.gov ID
- NCT01506336
- Acronym / sponsor ID
- AB07001
- Conditions
- Gastro Intestinal Stromal Tumor
- Keywords
- GIST, resistant, imatinib, gastro intestinal stromal tumor resistant to imatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Jan 2012 (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.
The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| masitinib | Experimental | Drug: masitinibmasitinib 12 mg/kg/day |
| sunitinib | Active comparator | Drug: sunitinibsunitinib 50 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological proven, metastatic, or locally advanced and non-operable GIST
- Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
- C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
- Patients resistant to imatinib at dose of 400 mg/day
Key exclusion criteria (2 listed)
- Patient treated for a cancer other than GIST cancer 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
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 |
|---|---|---|
| masitinibmasitinib 12 mg/kg/day | Drug | masitinib |
| sunitinibsunitinib 50 mg/day | Drug | sunitinib |
Primary outcome
overall progression free survival
Time frame: up to 36 weeks
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
1 secondary outcome
overall survival
Time frame: up to 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Results publication: PubMed 25122671Adenis A, Blay JY, Bui-Nguyen B, Bouche O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blesius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-1769. doi: 10.1093/annonc/mdu237. Epub 2014 Jul 25.
- Publication of clinical study resultsLink provided by the sponsor.
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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.
Axel Le Cesne, MD principal investigator
Institut Gustave Roussy, Villejuif, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing masitinib and sunitinib in people with Gastro Intestinal Stromal Tumor, run by AB Science at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall progression free survival (time frame: up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506336, which also lists 1 linked publication.
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 11 Dec 2018.