Gastro-intestinal Stromal TumoursPhase 2NCT00998751
Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
A Phase 2 study testing oral masitinib in people with Gastro-intestinal Stromal Tumours, run by AB Science at 1 site in France.
Trial summary
The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-intestinal Stromal Tumours
- What is being tested?
- oral masitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Jun 2013
- 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
- Male or Female patients, age >18
- Life expectancy > 6 months
- Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST.
- Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy
- C-Kit (CD117) positive tumors detected immuno-histochemically
- Measurable tumor lesions with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan
Who cannot join
- Documented allergy to the similar drug of AB1010
- Inadequate organ function
- Patients with a history of any other malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.
- Conditions
- Gastro-intestinal Stromal Tumours
- Being tested
- oral masitinib
- Keywords
- cKIT inhibitor, GIST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral masitinibDrug
Also called AB1010
7.5 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| masitinib (AB1010) | Experimental | oral masitinib 7.5 mg/kg/day Receives: Drug: oral masitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)
Measured: 2 months
Secondary outcomes (1)
Progression Free Survival
Measured: until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJun 2005
- Primary completionJun 2013
- Study completionJun 2013
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 TumoursStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998751
- Sponsor's protocol ID
- AB04016
- Status last verified
- Dec 2018
- First submitted
- 19 Oct 2009
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Cesne A, Blay JY, Bui BN, Bouche O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naive patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6.
PubMed 20211560
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
- Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
- ClinicalTrials.gov ID
- NCT00998751
- Acronym / sponsor ID
- AB04016
- Conditions
- Gastro-intestinal Stromal Tumours
- Keywords
- cKIT inhibitor, GIST
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Oct 2009 (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 evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| masitinib (AB1010) | Experimental | Drug: oral masitiniboral masitinib 7.5 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female patients, age >18
- Life expectancy > 6 months
- Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST.
- Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy
- C-Kit (CD117) positive tumors detected immuno-histochemically
Key exclusion criteria (3 listed)
- Documented allergy to the similar drug of AB1010
- Inadequate organ function
- Patients with a history of any other malignancy
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 |
|---|---|---|
| oral masitinibAlso: AB10107.5 mg/kg/day | Drug | masitinib (AB1010) |
Primary outcome
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)
Time frame: 2 months
1 secondary outcome
Progression Free Survival
Time frame: until disease progression
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 20211560Le Cesne A, Blay JY, Bui BN, Bouche O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naive patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 oral masitinib in people with Gastro-intestinal Stromal Tumours, 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 6 inclusion and 3 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?
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) (time frame: 2 months). 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 NCT00998751, 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.